5 Ways to Streamline Multi-Site Clinical Trial Management

Clinical trials are complex and expensive endeavors that require researchers to track enormous amounts of data, manage multiple stakeholders/participants, and communicate efficiently - all while following protocols. And that's just single-location trials!

But what happens if your clinical trial needs to run across many different sites? Then all of this complexity increases substantially, so you'll need to streamline your multi-site clinical trial processes and procedures to ensure it is completed on budget and schedule. Use our tips below to improve your multi-site clinical trial administration.

5 Ways to Streamline Multi-Site Clinical Trial Administration

1. Use a Centralized Cloud-Based Oversight Tool

2. Automate Processes Across Sites

3. Improve Information Sharing and Communication Efficiency

4. Systematize Your Outcome Tracking 

5. Stick to the Schedule

Use a Centralized Cloud-Based Oversight Tool

One of the easiest ways to improve multi-site clinical trial administration is to ensure that you have a single source of truth for the aggregation of information from each of your locations. This enables real time oversight of protocol adherence and results tracking back oversight teams, from safety committees to DMC to sponsor and CRO administrators. Ideally, invest in a cloud-based system that can be accessed by approved individuals from any location that communicates with or replaces other tools. This will provide your team with a centralized system for managing  communications, processes, and reporting. 

Pro-tip, a software like Cloud Concinnity can help in this regard. Our cloud-based platform was built to meet the specific needs of clinical trial oversight committees. 

Automate Processes Across Sites

Introducing automation into your multi-site clinical trial administration is a must for improving the operational efficiency of multi-site trials. With automation, you can eliminate many of the manual aspects of clinical trial administration - scheduling meetings, sharing notes, creating and approving required documentation, etc. Automation can also help to eliminate errors, reduce the risk of delays and noncompliance and ensure standardization. 

Improve Information Sharing and Communication Efficiency

With many different clinicians and researchers across the sites, a strong communication platform is critically vital in efficiently administrating your multi-site clinical trial. Researchers will need to be able to communicate with each other easily and quickly. They’ll also need to be able to share and access critical data files effortlessly.

This is where using the right tool can make all the difference. Make sure your communications and confidential data are being transmitted across secure, Part 11 compliance systems. 

Systematize Your Outcome Tracking

Outcome reporting can be a significant time investment in multi-site clinical trial administration. To improve your management efficiencies, we recommend systemizing your outcome tracking and reporting. Work with all of your different locations to ensure that they are reporting outcomes in a consistent manner - one that can easily be fed into your reporting frameworks.

And make sure that those outcomes make it all the way from multiple sites to the critical safety and oversight teams charged with deciding on trial progression. A system like Cloud Concinnity can help to streamline your outcome reporting, tying outcomes and communications around them to multiple systems and locations in real time.

Stick to the Schedule

Lastly, with so many different variables occurring simultaneously in a multi-site study, it can be easy to fall behind. A consistent schedule of milestones and deadlines is critical to ensure that your team stays on track. 

Be sure to hold your team accountable to these expectations and implement systems to track progress against these milestones. 

Ready to optimize and improve your multi-site clinical trials? We can help! Our system was built to meet the needs of your multi-site clinical trial.

Contact us today for a free demo of Cloud Concinnity to learn more about how our tool can help you streamline your next trial.

3 Ways Your Clinical Trial Software Can Help You Attract and Retain KOLs

Key Opinion Leaders (KOLs) are critical to the success of any research study. The experience and credibility of your KOLs add legitimacy to a clinical trial while also helping to mitigate any potential risks. As such, attracting KOLs to your study, and keeping them engaged for future research studies, is an important element in driving long-term success. Working with our clients, we’ve identified that a driving factor in attracting and retaining KOLs is to improve the quality of life for trial KOLs. The better the experience your KOL has working on your trial, the more likely you are to retain that KOL for future studies. This blog post breaks down three ways a clinical trial oversight system can help you attract and retain KOLs. 

Understanding The Role of KOLs

As you already know, KOLs can be invaluable in meeting trial goals related to: 

• Patient enrollment and retention.

• Clinical trial protocols/processes design.

• Leveraging knowledge from prior studies and work in the field to implement best practices.

To properly support KOLs across all of these areas of responsibility, it’s critical that your clinical trial software provides the data and time-saving efficiencies that improve the quality of life for your KOLs. 

3 Ways Your Clinical Trial Software Can Help You Support Your KOLs

1. Reduce the time it takes to schedule meetings. 

2. Eliminate an overreliance on paperwork. 

3. Let them communicate/engage on their preferred timelines. 

Reduce the Time it Takes to Schedule Meetings

KOLs are in high demand, and their time is valuable. Your software should make it easy for KOLs to schedule meeting times that work for their busy lives. This includes allowing KOLs to see available time slots and providing automated reminders about upcoming meetings.

Your software should also make it easy for KOLs to prepare for meetings. It should provide access to relevant study materials and give KOLs the ability to take notes during meetings.

Clinical trial software, like Cloud Concinnity, allows oversight teams to quickly poll each other for availability and schedule meetings with ease. This eliminates cumbersome back-and-forth so that your KOLs can focus their time on the success of the study. 

Eliminate an Overreliance on Paperwork

Don’t bog your KOLs down with copious amounts of paperwork. Relying on outdated methods of collecting and consolidating data can have an immediate negative impact on your KOLs’ quality of life. 

Instead, take your note-taking to the cloud and empower your KOLs with the tools they need to effortlessly capture and share their notes with their team without the need to scan documents or mail physical copies. 

Further, a tool like Cloud Concinnity allows your team to determine accessibility and security roles so that you can have confidence that only the permitted individuals are able to access the file. 

Let them Communicate on Their Preferred Timelines 

As we said before, KOLs are often busy people with hectic schedules. It’s important to let them communicate on their preferred timelines. Your clinical trial software can help you manage communication with KOLs by allowing you to send automatic updates and reminders. This will ensure that KOLs always have the most up-to-date information about your study and reduce the likelihood of missed deadlines.

Further, your platform should be device-agnostic, meaning that whether your KOL is in front of their desktop device or using their mobile phone, they should be able to drop in comments/notes quickly.  

By making it easy for KOLs to work with you, your clinical trial software can help you attract and retain the experts you need to make your research successful.
If you’re looking for a cloud-based clinical trial oversight tool to help take your KOLs to the next level, look no further than Cloud Concinnity. Cloud Concinnity is a robust platform that empowers your trial oversight teams and data monitoring committees with a single, secure hub that centralizes all patient information, communications, processes, and reporting. If you have any questions or would like to see a free demo, please reach out to us today.

4 Driving Forces: Why Clinical Trial Oversight Committees Need Smarter Software

When demand for new treatments increases, such as the immediate need for a vaccine for a novel coronavirus, it can pressure clinical trials to deliver fast, accurate, and positive results. These pressures have the potential to increase the risk of errors, mistakes, or the mismanagement of data – which is why we have clinical trial oversight committees. They ensure the accuracy and integrity of the study. However, as clinical trials become more complicated, these teams must utilize more intelligent software that empowers them with the tools they need to meet their obligations.

This article breaks down the four driving forces for why clinical trial oversight committees need smarter software to complete their mission effectively.

 4 Forces Driving the Need for More Powerful Clinical Trial Oversight Software

Clinical trials are incredibly complex endeavors that require the management of many different variables, including dosages, outcomes, and the health of possibly hundreds of participants, among others. Without the right tools, it can be overwhelming for an oversight team to meet its obligations to all of its stakeholders, including trial participants.

Driving Force 1: The Need to Maintain Participant Safety

A critical part of any clinical trial is maintaining the safety of its participants. A study that fails to accomplish this most fundamental pillar of clinical trials will lose integrity and respect amongst the medical community. Even worse, it can lead to the injury and even death of its participants.

While the researchers are doing everything they can to ensure participant safety, the oversight committee provides a critical, independent role, keeping track of study outcomes consistent with the protocols devised at the offset of the study. 

Smart Software like Cloud Concinnity allows researchers and committee members to track the progress in real-time, from any location - ensuring that participant safety is maintained throughout the study.

Driving Force 2: Managing Multiple Data Sets

Clinical trials produce enormous amounts of data. From variations in patient health to dosages to dropout rates, it's a lot to keep track of. And that's why oversight teams need a system that can provide a single source of truth for this data.

Further, the right system can also help ensure that the data is only accessible to those with the appropriate permission to access the data.

Pro Tip: We built the Cloud Concinnity platform to empower researchers with a cloud-based system to collect all the data from the trial and store it in a central space. This is imperative for clinical trial oversight committees to quickly review this data and ensure that everything is being tracked properly.

Driving Force 3: Oversee Complicated Study Process and Protocols

At the beginning of a clinical trial, protocols and rules of conduct are established. It's imperative that these protocols and rules of conduct are followed consistently and throughout the course of the study to ensure the accuracy of the data and the results, as well as participant safety.

 The clinical trial oversight committee is responsible for overseeing and ensuring that the researchers follow these protocols and rules of conduct throughout the course of the study. The best way to accomplish this is with software that allows its users to view real-time progress of the study and compliance with these protocols.  

Driving Force 4: Ensure Accurate Recommendations

One of the most pivotal responsibilities of a clinical trial oversight committee is its role in recommending next steps, in real time, as the study progresses. The oversight committee is responsible for making recommendations about the study's continuation, modification, or termination.  

 And what factors go into these recommendations? Everything that we've described above:

• The health of the participants

• The integrity of the data

• The adherence to the progress and conduct of the study  

In this way, smart software like Cloud Concinnity is the most valuable tool that the clinical trial oversight committee has at its disposal since it ensures that the recommendations the committee makes are accurate and based on the most important factors of the study. Manual based processes can no longer keep up with the new pace of clinical trials.

Implementing Cloud Concinnity for Your Oversight Committee

Cloud Concinnity software is custom-built for clinical trial oversight, which makes it the best option for anyone trying to ensure the integrity of a study. For a free demo of Cloud Concinnity, please reach out to us. We are happy to answer any questions that you have, and we're here to help.

5 Tips for Standardizing Your Clinical Processes

Clinical trials are essential to the success of new medical treatments and therapies. They help researchers study the effects of new treatments in a safe, controlled environment before these treatments are made available to the wider public. 

However, running clinical trials can be expensive, time-consuming, and difficult. There are many different factors to manage, data to collect, and patients to monitor. This is why it's so important to develop standardized processes. Process standardization  will drive efficiency as well as enhance safety and ensure compliance as you complete your trial.

In this blog post, we’ll discuss five tips that will help you standardize your clinical trial’s processes.

1: Document Protocols 

Before you begin your clinical trial, it’s important to develop clear and concise protocols. Documenting what must be done when, by whom will ensure that end goals will be met in compliance with SOPs, charters and regulators. These will be the guidelines that you and your team will follow throughout the course of the study to ensure that it’s successfully completed on time.

When developing these protocols, your team should try and account for the goals of the study and the requirements needed to complete these goals. This document should outline the objectives of the trial, the eligibility criteria for participants, and the procedures that will be followed during the study for everything from recruitment to oversight to FDA application and review. 

Begin with the end in mind! By laying this foundation at the beginning and developing a protocol upfront, you will be able to avoid potential delays and disruptions during your clinical trial.

2:  Mapping Processes Is Key

Mapping out your clinical processes is key to standardizing them. By understanding the steps involved in each process, you can identify where improvements can be made and what needs to be done to streamline the process.

Additionally, understanding your processes can help you troubleshoot issues that may arise during a clinical trial. There are many benefits to mapping out your clinical processes. By doing so, you can:

• Improve efficiency and quality

• Reduce variation in how tasks are performed

• Facilitate training of new staff

• Make it easier to identify potential risks

• Improve compliance with Good Clinical Practices (GCPs)

3: Optimize Data Management

One of the most important parts of a clinical trial is data collection, as the data will be used to determine the conclusions that the decision makers are able to draw from the study. But how to ensure that you’re providing all of the right information to the right people at the right time? 

One way is to develop standard operating procedures (SOPs) for the collection, aggregation and dissemination of information to decision makers. SOPs outline the steps that should be taken during each stage of the clinical trial, from screening participants to closing out the study. SOPs also ensure that everyone working on the study is on the same page, as the standardized procedures are widely available to everyone. This can prevent miscommunication and eliminate incomplete data collection at different points in the study.

To further improve your data analysis, the data collected in your study can be aggregated into an integrated software platform like Cloud Concinnity. This will allow for centralized access to and control of information critical to decision makers at key trial stage gates. Cloud based, integrated systems allow you to centralized your research data in one place so research teams can access it whenever and wherever needed.

4: Leverage Clinical Trial Software

Managing the various components of a clinical trial can be complex and challenging,.especially when it comes to communicating standardized processes to the broader team and holding them accountable for adhering to those standards. 

To help simplify this, it’s important to use clinical trial software that actually has a process management engine at its core. Process management engines eliminate the variability inherent in manual processes by automating them. By eliminating as many manual processes or point software solution bottle-necks as possible, you can create an environment where your team is more likely to abide by a standard process. Automating clinical processes improves efficiency and accuracy saving time and money and eliminating process variability that can put your study at risk. 

Cloud Concinnity is purpose built to bring good process to clinical trial oversight. It offers unparalleled advantages to anything on the market today by centralizing, standardizing & automating oversight of key trial elements. Oversight teams need a single secure platform to support decision making at key stage gates to ensure quality, efficiency, accountability and control

5: Create a Budget and Follow It

Clinical trials can be expensive and time-consuming, and it’s easy for costs to get out of hand.  That’s why it’s so important to develop a budget for your trial. An accurate budget should take into account expected expenses as well as costs of similar, previous trials to incorporate a historical basis of how much the study should cost. Expenses can range from participant payments, to research supplies, to software to help you track and complete your research trial.

By detailing all of these costs in a budget before the study begins, you’ll be able to avoid potential financial problems during your clinical trial. This will help to ensure that your study is completed on time and within budget.

In summary, developing the standardized processes for your clinical trial will help you manage all of the different factors of the study. And  software like Cloud Concinnity can help your team manage these factors, collect data, and communicate effectively and easily. For a free demo of Cloud Concinnity, please feel free to reach out to us today. We’re here to help.

Product Update: Get More Out of Your Clinical Trial Meetings

As a leading clinical trial oversight solution provider, our team of experienced subject matter experts and engineers consistently explores new features to build into the Cloud Concinnity® platform. 

In speaking with our clients, we heard time and time again that they were concerned about their meeting efficiency. They felt that with their current tools, getting everyone’s schedules aligned to set a meeting was taking too much time. It was also hard to ensure that the meetings were productive as after the meeting, they had to spend even more time transcribing and distributing accurate minutes.

Time to Maximize Your Meetings with Two New Cloud Concinnity® Product Features

From this feedback, we’re excited to announce two new features to help clinical trial managers get more out of their meetings. 

1) Intuitive Meeting Scheduling Feature 

Are you tired of sending countless emails going back and forth on meeting availability? Cloud Concinnity® has you covered!

With our new intuitive meeting scheduling tool, your team can easily sync their open availability within the tool by polling meeting participants with various possible dates and times (or ask for both availability and preference). 

Meeting participants can even respond to the poll without logging into Cloud Concinnity! Poll results are shared with the other attendees as they are received. After the survey, the meeting is scheduled and pushed to all participants’ calendars. This makes it a breeze to schedule meetings with multiple stakeholders while eliminating costly administrative time. 

2) Improvements to Meeting Minutes Editing

Capture notes, takeaways, and action items easily via the improvements we’ve made to our meeting minutes editing tool. 

Now, on the Cloud Concinnity platform, meeting attendees can simultaneously share comments and annotations on draft minutes. These can be tracked on the draft of the notes, enabling the decision-maker to finalize the minutes quickly. Employing additional Cloud Concinnity features, like integrated electronic signatures, task reminders, and workflows, the finalized minutes can be signed, appropriately shared, tagged, and securely preserved. 

What Do These Menu Enhancements Mean For You?

• Easier time scheduling meetings. 

• Shared collaboration on meeting notes. 

• More efficient communications. 

This means that your team can spend less time dealing with meetings and more time working on successfully completing your trial. Now that you know what the new features are and how they can help you, start taking advantage of them today! Your team will be more productive and efficient in no time.

Our Continued Commitment To Supporting The Clinical Trial Oversight Landscape

At Cloud Concinnity®, we are confident that the future of clinical trial oversight is digital. To support the evolving needs of clinical trials and the expectations of trial stakeholders, oversight committees need to embrace the best possible digital technologies available. If you aren’t already a Cloud Concinnity® customer, now’s the perfect time to learn more about how we help improve the success rate of clinical trials. 

If you have any suggestions for new tools or platform features that you’d like to see become part of the Cloud Concinnity platform, let us know. 

5 Reasons to Embrace Adaptive Design In Your Next Clinical Trial

Most traditional clinical trials operate under a model similar to: design the trial, conduct the trial, and then analyze the research. This has been the model for most medical research in the past and remains the predominant model to this day. But times change.  

There is a newer, more flexible trial structure that is starting to make the rounds through the clinical trial space – adaptive design. Adaptive design offers many benefits to the researchers and the participants in a clinical trial. In this post, we'll break down everything you need to know about adaptive design, along with ways that it can help you improve your next clinical trial.

What is Adaptive Design?

Simply put, adaptive design trials incorporate real-time results from the trial into the trial itself, modifying the trial's design. This feedback loop results in trials that often save time and money by incorporating efficiencies that arise during trial research. An essential requirement for adaptive design is that any changes made during the trial must maintain the validity and integrity of the trial, being careful not to insert any bias into the study results.

Why Aren't Adaptive Design Trials Used More Often?

Despite existing for roughly 25 years, adaptive design trials are still less common than fixed sample trials. This may be due to several reasons, including:

• Confusion around how they can be used.

• Uncertainty on when to use them.

• Not confident in the benefits/results of using adaptive design.

As more people experience the benefits of adaptive design trials, we expect to see more trials embrace this benefit-driving methodology. 

5 Reasons to Embrace Adaptive Design

Reduces the Length of the Trial 

By incorporating efficiencies and evidence as they naturally arise in the trial, researchers can reduce the length of the trial through adaptive designs. In a fixed design trial, the treatment, and doses, of the patients at the beginning of the trial cannot be changed, despite what may arise in the trial.

This can result in time and resources being misused, as certain groups may respond better to specific treatment doses. Or some groups, at a lower dose, may not respond at all. Incorporating this information can lead to abandoning ineffective doses and focusing instead on dose quantities and perhaps groups that benefit more from the treatment.

Reduces the Number of Patients Needed for the Trial.

Similar to how adaptive design can reduce the length of a trial, it can also reduce the number of patients needed for a trial.

For example, let's say that a dose of the drug being researched is found to be ineffective. In an adaptive design study, the dose can be increased and given to the same patient. In a fixed sample study, this change in dose would likely have to occur in a different study if it wasn't planned from the beginning.

This would result in redundancies and a needless delay in collecting information. But the ability of an adaptive design study to incorporate the change into the same patient sooner reduces the number of patients needed in the trial.

Increases the Speed to Market of Pharmaceutical Drugs. 

Since the length of the trial can be shortened, this also increases the speed with which these medicines are made available to the market. This increased speed is invaluable, as it can save people's lives while also resulting in increased revenue for the company.

Reduces the Costs of Clinical Trials. 

In addition to the above factors, adaptive design can significantly impact the cost of the clinical trial. By reducing the number of patients and the trial length, the costs of an adaptive design study are also reduced.

On the other side of the equation, revenue is likely to start rolling in sooner since a shorter trial means that the medicine will often get to the market faster.  

Adaptive Design Can Be Used in a Variety of Trials

We've been discussing how your team can use adaptive design in early clinical trials. But adaptive design isn't limited to those. It can be used in various trials, from standard clinical trials, to early-stage, to post-market. The main limitation is the ability of a team to track the changes and the data that comes out of these adaptations. And that's where Cloud Concinnity comes in.

How to Reap the Benefits of Adaptive Design?

While the benefits of adaptive design are clear, it is more complex and often has more variables to balance than a traditional fixed design trial. An adaptive design trial requires careful consideration, forethought, planning and more intensive oversight. Data will need to be closely tracked and analyzed, and more meetings will need to occur to communicate changes and other important information effectively. However, the benefits are worth it.

We firmly believe that adaptive design is the way of the future, which means that oversight teams will also need to embrace adaptive design. Luckily, Cloud Concinnity offers a streamlined, cloud-based system that will empower your team with the smart tools they need to meet the oversight challenges of adaptive trials. It also allows for asynchronous communication, which will reduce the need for meetings and allow your team to easily and quickly keep in touch.

To request a demo, reach out to Cloud Concinnity today.

Trial Management: Five Benefits of Asynchronous Collaboration

In clinical studies, time is of the essence. Every moment counts, as any delay or misuse of time can directly affect when a potentially lifesaving drug can get to the market. Many factors can squander time during a study. Some are inevitably outside of your control, but others aren’t.

Constant in-person meetings, status checks, and message response delays can eat up valuable time in your clinical trial, distracting your team from focusing on the more significant issues. This is where asynchronous collaboration can help your team save time and finish your study successfully. This blog post breaks down everything you need to know about the benefits of asynchronous collaboration.

What is asynchronous collaboration?

First, let’s define synchronous collaboration. This is any communication where two or more people communicate in real time with immediate responses. In-person meetings, desk chats, and phone calls are examples of synchronous collaboration.

Asynchronous collaboration doesn’t occur in real time and includes forms of communication like emails, project management updates, or, depending on the context, direct messaging.

There are benefits to each type of collaboration, and both are essential to a successful trial. But not all communication needs to be synchronous. Asynchronous collaboration offers a host of benefits for trial management, as it gives your team freedom and flexibility to complete your study efficiently.

4 Benefits of Asynchronous Collaboration in Trial Management? 

1. Increase Focus Time to Increase Productivity 

   One of the biggest reasons to move to asynchronous collaboration is to give your team more time to focus on their work. With synchronous collaboration, a person’s attention is constantly being pulled in another direction. There are always meetings to attend, interruptive messages to respond to, and phone calls to pick up.

   This constant need to collaborate in real-time removes the ability of someone to focus for long periods on a particular problem. These long periods of focus are imperative for addressing the more complex issues that arise in a clinical study and ensuring that your team stays productive during the trial. Key Opinion Leaders (KOLs) on whom your trial depends, are extremely busy physicians and/or academics whose work demands uninterrupted time. Asynchronous collaboration provides everyone with space to focus on their critical work.

2. Reduce Hard and Soft Costs

   Asynchronous collaboration can help lower your trial’s operational costs by reducing the number of in-person meetings, expensive conferencing systems, and other communication distractions. Fewer meetings mean lower travel costs, lower opportunity costs from the loss of productivity (due to the number of meetings), and reduced hard costs in conference software or equipment. The combined effect of the study is lower overall costs.

3.  Increase Decision-Making Speed

   Asynchronous collaboration has the added benefit of increasing decision-making speed by clearing the lines of communication and allowing everyone to contribute.

   Not everyone may have the time, ability, or option to voice their opinion in a face-to-face or teleconference meeting. But with asynchronous collaboration, everyone can contribute, which allows for more diverse ideas and an easier job of making decisions by those in charge.

   Plus, you don’t have to wait around for everyone’s schedules to align before you can talk through a decision.

4. Facilitate Alignment on Key Initiatives 

   Asynchronous collaboration and collaboration, if done on an integrated platform, records the contributions of everyone involved and is available for all to see, aiding in  the final decision-making. This helps colleagues gain alignment on critical initiatives.

   These records also help to create a history of activities, actions and decisions for reference during the trial and auditing after.  This improves consistency and compliance. 

   These four benefits improve clinical trial efficiency, essential to implementing and completing the trial safely and effectively. 

   This efficiency will increase revenue and help those in need by getting the drugs to market faster.  In order to realize these benefits, you will need to utilize an integrated, cloud-based communications and collaboration platform.  

3 Asynchronous Best Practices

Set Deadlines and Communication Expectations

With synchronous communication, the expectation is that someone will respond immediately. But with asynchronous collaboration, things are different. There are no clear rules or guidelines on when someone should or has to respond.

Setting these guidelines is imperative to successful asynchronous collaboration, so it’s essential to set clear deadlines and expectations. Perhaps it’s responding to messages within a day or emails within 24 hours. Whatever your guidelines, set clear expectations to ensure that your study runs as smoothly as possible.

Use Labels and Tags

By the very nature of asynchronous collaboration, there will be different times when messages are sent, received, read, and responded to. Therefore, it’s important to have a system to determine if a communication is in review, needs feedback, requires input, or is approved.

This is where labels and tags come in. These tools can be instrumental in letting colleagues know when a communication has been reviewed or approved. In this way, they also help with decision-making and gaining alignment between colleagues and will help the trial run as smoothly as possible.

Standardize Processes

While asynchronous communication lacks some of the benefits of synchronous communication, it’s important to remember that asynchronous communication is also about collaboration. It’s the review and approval of information in accordance with study protocol.  Standardizing your process will save everyone time and resources and ensure safe and compliant execution. An integrated, cloud-based communications and process management platform will automate your process creating even greater efficiency.  

This is where a platform like Cloud Concinnity comes. Concinnity’s integrated, compliant, process management  platform centralizes all information & communications, standarizes, automates & tracks all required processes adding efficiency, speed and risk mitigation & driving significant positive financial impact.

Implementing Cloud Concinnity for Asynchronous Collaboration

The best way to implement asynchronous collaboration is with a platform like Cloud Concinnity. While other smart programs may offer communication options or large quantities of information, Cloud Concinnity offers a flexible, cloud-based software that is built specifically for clinical trials. It allows researchers to collaborate within the platform and syncs into other trials, ensuring the successful and timely completion of a trial through effective use of asynchronous collaboration.

If you have any questions or would like to request a demo, feel free to reach out. At Cloud Concinnity, we’re here to help.

The Future of Dose Escalation Management

Dose escalation studies have been used as a cornerstone in medical research to determine the most effective dose of a drug. They are usually part of early-stage, phase I clinical trials. But like so many things in our world, the COVID-19 pandemic changed how researchers approach dose escalation management. The immediate demand for a healthy, effective vaccine showcased the need for evolving best practices and spurred researchers to adopt new technologies.

These advances have spread beyond the COVID-19 vaccines and will likely reverberate throughout the field. So to best prepare you for the future of dose escalation management, we break down these changes and the new technologies below.

How Does Dose Escalation Work?

In phase I trials, dose escalation works by finding the most effective dose of a drug; that which prevents patients from being exposed to harmful or sub-therapeutic doses of the drug.

This is a fine line to walk.

As researchers seek to avoid harm, patients are often put on lower doses that are often sub-therapeutic. The dose amount is then increased, to better identify effective doses while minimizing any harmful effects to patients. This process requires diligent management and careful consideration of all the factors involved.

Why Is Dose Escalation Important?

If the dose is sub-therapeutic, precious time and resources are misused, and the patient isn’t given effective treatment as the dose isn’t high enough to be beneficial. On the other hand, if the amount is too high, the patients may be subjected to unnecessary risk, discomfort, and unpleasant side effects.  

Dose escalation seeks to find the effective dose by slowly escalating the doses in different patient groups. However, this requires the expertise and ability to manage and analyze the data of different patients within different groups by researchers while allowing these researchers to communicate effectively and quickly.

That’s a lot to manage! Luckily, this is where the Cloud Concinnity Platform comes in.

The Importance of Technology in Dose Escalation Management

The implementation of dose escalation in phase I clinical trials requires the close monitoring of each patient’s dose and response to these doses, along with various other factors. The necessary data to track quickly adds up. So how can technology help your team manage these factors?

Providing Patient Data at Your Fingertips

Cloud Concinnity offers a solution to these problems through an easy-to-use, cloud-based software that allows an oversight committee, such as the DMC, to see what’s happening with individual patients and their dosing. This clarity of information and detail of data is invaluable when determining the correct dosing for a patient and ensuring that a study’s resources are utilized as effectively as possible.  

It also allows committees and teams to make better decisions about whether or not the study should proceed. If a statistically significant number of patients aren’t responding to treatments or, worse, are reacting negatively, this will be readily apparent. This can save time, resources, and money in ending or reworking ineffective trials early.

Reducing Administrative Burden

Moreover, technologies like Cloud Concinnity reduce the administrative and operational complexity of dose escalation trials by allowing teams to keep track of patient data and communicate quickly and effectively. And, since this is all cloud-based, it’s available for any researcher to access while also providing a central point of access.

Increases Communication

These trials often require more meetings and communication between researchers, as the nuances in the data brought about by dose escalation spur debate or discussion between researchers. Luckily, we’ve created the ability for them to meet asynchronously with the Cloud Concinnity Platform, which saves valuable time and increases the power of the team to communicate effectively.

Standardizes and Automates Processes

Many of the changes brought about by the COVID-19 pandemic aren’t going anywhere any time soon. And while the need for the most efficient, safe, and effective trials utilizing dose escalation management was prevalent before the pandemic, they are even more critical now. Researchers are using dose escalation management techniques in various fields.

This increased focus on dose escalation management means that teams will need smarter process management software to help them navigate these studies designed to find the correct dose for a drug that can potentially save millions of lives. And the best way to manage dose escalation trials is with software like Cloud Concinnity, which provides the cloud-based flexibility and ease of communication that will help your team succeed.  

While other platforms may offer communication or documentation, Cloud Concinnity provides the security and capabilities to meet the compliance requirements of a clinical study. If you have any questions or would like to see a free demo of our software, please get in touch with us. We are here to help.

7 Ways Data Monitoring Committees Can Improve Clinical Trial Trust

Sponsors of clinical trials are under pressure to maintain patient safety and data quality, but the process is time-consuming and challenging to manage. This is where more intelligent clinical trial oversight software comes in handy. The correct clinical trial oversight software can automate many of the tasks associated with clinical trial oversight, improving sponsor trust. This blog post will discuss seven ways smarter clinical trial oversight software can enhance trust between sponsors and investigators.

Improve Communication between Sponsors and Investigators

All trust is built on effective two-way communication. By providing a central repository for clinical data and communication, clinical trial oversight software can help ensure that everyone involved is on the same page by automating email alerts and reminders. In doing so, clinical trial oversight software can help reduce the risk of missed deadlines and communication breakdowns.

Improve Clinical Trial Data Quality 

To effectively build sponsor trust, there needs to be confidence in the data collected during the trial. More innovative clinical trial oversight software can improve data quality by automating data collection and analysis. This can help ensure that collected data is accurate and complete while reducing the risk of human error in data entry and analysis.

Provide Real-Time Data Access

Another way that clinical trial oversight software can help foster sponsor trust is by providing transparent access to real-time data. This means that sponsors can view what is happening in the trial at any given time and can make decisions accordingly. This level of transparency can help to improve communication between all parties involved in the trial and help to ensure that everyone is on the same page.

Provide Data Analysis Flexibility 

With the right clinical trial oversight tool, sponsors can choose the level of detail they want to see in the data and tailor the reports to their specific needs. This customization level can help make sure that sponsors are getting the information they need when they need it. It also enables sponsors to designate access tiers based on the needs of the supporting team.

Streamline Operations

Clinical trial oversight software can automate many of the tasks associated with clinical trial management, freeing up time for sponsors to focus on other aspects of their job. This automation can help reduce the time required to complete a clinical trial and empower the sponsor to bring the clinical drug to market sooner. 

Sponsors are trusting that the sites conducting their trials are following the proper procedures to ensure patient safety and data quality. But with so many moving parts in a clinical trial, it's hard for sponsors to know what's really going on at each site. Clinical trial oversight software can help streamline these operations while providing transparency into the current stage of each clinical trial

Improve Patient Safety By Improving Data Accuracy 

It’s not just sponsors that can benefit from clinical trial oversight software; this software can also improve patient safety. Inaccurate data is one of the leading causes of patient safety issues. By offering a higher degree of data accuracy, clinical trial administrators and sponsors can feel more confident that the data they are gathering is accurate and up to date, empowering these individuals with the information they need to make swift, data-backed decisions for the trial can improve the patient experience.

Increase Data Security

The more secure the clinical trial, the more trust can be built with clinical trial sponsors. This can be done by using clinical trial oversight software that is HIPAA compliant and has been tested for security vulnerabilities. Another way to increase data security is by encrypting all data collected during the clinical trial. This will ensure that only authorized personnel can access the data and that it remains tamper-proof. 

Clinical Trial Oversight software can also help reduce the risk of fraudulent activities. Fraudulent activities can occur at any stage of a clinical trial. However, by using clinical trial oversight software, sponsors can reduce the risk of fraud by increasing transparency and visibility into all aspects of the trial. This software can also help to identify potential red flags that may indicate fraudulent activities and improve the security (and integrity) of the trial. 

Build Sponsor Trust With The Right Clinical Trial Oversight Software

The cost of a clinical trial oversight software pales compared to the rest of the study costs, especially relative to the benefit they can provide. Consider using clinical trial oversight software if you’re looking for a smarter way to manage your clinical trials. Clinical trial oversight software (like the Cloud Concinnity Platform) can help you build sponsor trust by automating many of the tasks associated with clinical trial management, improving data quality, and reducing the time required to complete clinical trials. 

Contact us today to learn more about how our clinical trial oversight software can help improve your sponsor's trust.

5 Considerations for a Successful Pediatric Trial

Pediatric clinical trials are essential for developing new and innovative treatments for children. However, they can be more challenging to conduct compared to standard trials as they require more oversight. There are a few key things to keep in mind when planning and conducting a pediatric trial to guarantee a positive trial experience. This blog post will outline five tips for a successful pediatric trial.

What Makes Pediatric Trials More Complex?

Pediatric trials are more complex than adult trials for a variety of reasons.

Smaller Patient Pool 

Children make up only 22% of the US population, and they generally have less severe illnesses. These considerations reduce the number of available participants in a pediatric study.

Data Collection in Pediatric Trials

Compared to trials with adult participants, who may only collect data by having the participant complete it, pediatric patients may not be able to complete the questionnaires or submit the data. This can easily lead to the data being captured in different ways, sometimes by different parents, a guardian, or healthcare professional.

Collecting Informed Consent from Children

Collecting informed consent for children can be more difficult, as children are not old enough to legally consent to a study. They might be able to provide consent through assent, but a parent’s consent is almost always necessary and appropriate. Acquiring these different types of consent will take time, as well as caring, compassionate conversations with both the patients and their parents.

5 Tips for A Successful Pediatric Trial

Allocate Enough Budget for Patient Recruitment & Trial Technology Support

Due to the complexities of a pediatric trial, it’s crucial to allocate enough funds to cover both patient recruitment and the technology that will be used to support the trial. Not only is the population of potential patients for pediatric trials smaller, but there can also be higher dropout rates as parents or patients find the study too demanding. It may be necessary to begin with a larger pool at the beginning of the study, which may require more investment than a standard trial recruitment effort.

You also want an appropriate budget for your trial technology support. Issues arising from technology that is either unknown to participants, or error-prone, can lead to delays and frustration in both participants and their parents - and these issues can easily lead to patients dropping out of the study. It’s important to invest accordingly in technology support to decrease the likelihood of dropouts.

Centralize Your Data Collection

As we mentioned above, the data collection in a pediatric study will likely be more diverse than in an adult study. Therefore, it’s important to collect and centralize the data gathered from various sources so that it can be analyzed effectively with the results from the rest of the study. Failure to do so could result in inaccurate results and conclusions from the study.

Utilize Child-friendly Protocols. 

As all of the participants in the study will be children, it’s imperative to have protocols that are best suited for them. These can manifest in different ways but could be as simple as having sessions that are no more than a couple hours long, or having breaks during the sessions. Along with the other tips listed above, these types of child friendly protocols will help decrease dropout rates.

Work With Caregivers and Parents to Eliminate Friction Points.

Raising children is already a difficult and stressful activity for most caregivers. And if a study adds additional stress to a family’s life, it can increase the likelihood that a patient will not complete the study.

To help reduce stress, it’s imperative that there are open lines of communication between trial staff and caregivers/parents. Do your best to identify and eliminate potential friction points before they become a problem for your study.

Be Aware of Your Timeline - Eliminate Unnecessary Meetings and Ensure Asynchronous Alignment to Avoid Costly Delays.

Timelines are implemented to help ensure the successful completion of your study. Adhering to them will increase the probability that your study comes in at or under budget. And revenue considerations aside, failure to complete your study on time could delay getting the medicine to those who need it the most. 

It’s important to streamline your communications to avoid unnecessary meetings to prevent these delays. By leveraging asynchronous alignment, you can be sure that everyone’s time is utilized effectively and efficiently - keeping your study on budget and on track.

One note of caution, while there are plenty of asynchronous tools on the market (email, messaging, document management apps, etc.), many lack the security, integration, and compliance-required tracking/reporting capabilities needed to meet the requirements of the clinical study. To ensure compliance, it’s important to select an asynchronous toolset that meets the traceability, auditability, and reportability required of a successful pediatric trial. 

Pro-Tip: Our asynchronous communication tools are a key feature of the Cloud Concinnity Platform. Through Cloud Concinnity, your team can comment and respond to critical questions, data notes, and action items in a secure, cloud-based environment – eliminating redundancies and helping to streamline communications. Learn more and schedule your Cloud Concinnity demo today.

By following these tips, you can increase the chances of a successful pediatric clinical trial. If you have any questions or concerns, please contact us. We are here to help. We are happy to give you a free demo of our cloud-based software that promotes collaborative communication, easy-to-follow processes, and transparent outcomes that help you complete your pediatric trial.

Introducing Collaborative, Real-Time Editing: Updates to The Cloud Concinnity Platform

Recent Updates to The Cloud Concinnity Platform - Collaborative, Real-Time Editing

As a leader in clinical trial oversight solutions, our team of dedicated engineers and subject matter experts are constantly improving Cloud Concinnity®, our integrated platform for centralizing, standardizing and automating data, communications, processes & reporting.   

We’re excited to announce the following enhancements to the Cloud Concinnity Platform designed to to better serve the needs of our current and future customers.

Improved Platform Feature: Collaborative, Real-Time Time Editing with Tracked Changes

We’re excited to announce the release of live editing with track changes functionality!

These new tools will empower your team with the opportunity to collaborate on finalizing board or committee meeting minutes and other critical documentation simultaneously. They’ll also have the ability to submit minutes for approval at the same time. 

A robust track changes feature will enable your team to see what edits have been made to a document (and by whom), allowing your approval team to accept additions to the minutes at their discretion.

How is This Helpful for Clinical Trial Oversight Boards, Teams, Committees and Administrators?

We’ve heard from several sponsors, CROs and administrators that asynchronous documentation can be a huge time-suck as well as introduce human error/risk to documentation. This is especially true if multiple individuals need to add their data/findings to the same document. 

In legacy systems, board members would need to send around the same document files to add their individual thoughts or make any edits, often through insecure email systems.

The result? 

Too much time wasted waiting on “your turn” with the document. Even worse, ensuring you were working with the latest version of a document could quickly get confusing as multiple versions of the same document would be passed around and renamed by recent editors (version 4 becomes version 6, etc.).

Our solution eliminates both the time-sink and version confusion. Now your entire team can work simultaneously on critical documents through our collaborative, cloud-based technology.

Our Commitment To Improving The Clinical Trial Oversight Landscape

We firmly believe that the future of clinical trial oversight is distinctly digital. Clinical trial oversight committees need the best tools to address today’s challenges. If you have any suggestions for new tools or platform features that you’d like to see become part of the Cloud Concinnity platform, let us know. 

Not yet a customer? See for yourself how Cloud Concinnity is improving operational efficiency and supporting the needs of clinical trial oversight boards and committees.

4 Ways Oversight Boards Can Operate More Efficiently

Oversight boards and committees play a critical role in ensuring the safety and efficacy of clinical trials. Given this responsibility, clinical trial oversight boards must function at peak performance. The more efficient the day-to-day operations of these boards, the more likely the study will be successfully completed on time and under budget. In this blog post, we will discuss four methods for ensuring your oversight boards can execute its duties more efficiently.

Improve Your Oversight Committee's Operational Efficiency With These Four Best Practices

Best Practice 1: Ensure Your Board Is All On The Same Page

An effective oversight board or committee is one that has a mix of medical and scientific expertise, as well as experience in clinical research. Ensuring that you have the right combination of skills around the table will help you accomplish more during internal meetings and reduce the need to bring in outside support to fill a skill gap. 

All members should have a thorough understanding of the study protocol and be up to date on any changes that have been made. They should also be able to have open, frank discussions about the study without feeling like they are being judged.

Honest communication is key to identifying and resolving potential issues before they can negatively affect the clinical trial.

Best Practice 2: Establish A Digital Homebase

If you want to improve the operational efficiency of your oversight board, it’s time to think beyond Dropbox files and shared Google or Microsoft Drives. Look instead for a central, shared, cloud-based home where your team can create, collaborate, approve and store your standardized documents. Ensuring important information like charters, agendas, minutes, and SMP letters during a clinical trial can save days, if not weeks, in labor time spent searching archives and emails for these files.  

Remember, time is money for sponsors and CROs. Time also represents quality of life for patients and families. Improve your communication cadence by ensuring your digital homebase can also act as a one-stop shop for all of the oversight activities that your committee is required to perform around that information.

Best Practice 3: Automate Where Able

DSMBs,DMCs, SRCs and other oversight committees often have to review large amounts of data during clinical trials as a critical function of their role. This can be a time-consuming process, particularly if the data is not organized in an easily accessible way. One way to make this process more efficient is to automate key processes. 

This is another instance where choosing the right clinical trial management platform can improve the operational efficiency of your clinical trial. Eliminate wasted time by automating repetitive tasks like meeting scheduling, document review, decision making and activity documentation with role-based workflows, task deadline alerts for more efficient execution of study oversight protocol steps.

Best Practice 4: Create End-to-End Transparency

To quickly make informed decisions, oversight boards need instant access to relevant data collected during the study. All participants in oversight processes  also need transparency into the current state of any outstanding tasks, assignments, or projects that team members are working on to reduce operational redundancies and eliminate the need for ad hoc status checks. 

Not only does complete transparency vital for improving oversight operational speed, it can also save time in proving security and compliance during the trial to regulatory bodies. A solid clinical trial management platform should come equipped with the tools you need to provide end-to-end transparency, including: 

Global Dashboards: Aggregate important information within and across your study.

System Integration: Make data from multiple sources more accessible.

Robust Reporting: Track and measure a multitude of metrics and activities through automated reporting.

Bonus Best Practice: Choosing The Best Software to Manage Your Clinical Trial

To operate as efficiently as possible, oversight boards and committees deserve the best possible software tools. Cloud Concinnity® was built specifically to meet the unique needs of clinical trial oversight boards. Our platform delivers facilitated access, controlled process, and transparent outcomes that support oversight committees and patient safety while bringing life saving therapeutics to market.

Schedule your free demo of Cloud Concinnity® to learn how our system can help make your next clinical trial a success. 

By far the number one way for oversight boards to operate more efficiently is to be proactive in identifying their needs instead of reactive when problems arise. Whether you're planning your next clinical trial, or you’re in the middle of one, now is the time to examine your systems and processes to identify ways to improve your operational efficiency.

Why Choosing the Right CRO Makes All the Difference

If you want to improve the success rate of your clinical trial, choosing the “right” Contract Research Organization (CRO) is critical. Several factors go into making this decision - from the experience and expertise of the CRO to their ability to meet your specific needs. In this blog post, we'll take a closer look at some of the most important considerations you should keep in mind when choosing a CRO and why finding the right fit can make all the difference in ensuring a successful clinical trial.

4 Benefits of Finding the Right CRO

The right CRO complements your strengths and fills in the gaps of your organization’s expertise.  They add invaluable capacity, while allowing you cost flexibility.  To the extent that a full service CRO is right for you, they can provide you with a wide range of services, including finding and vetting qualified vendors. 

By working with a CRO, you can focus on the core aspects of your clinical trial while ensuring that you get the best possible support and service from your vendors.

1) Expanded Capacity and Expertise

When able, try to work with a CRO that has experience relevant to specific characteristics of your trial - demographic being studied, the technology of the trial, the disease being studied, etc. This way, even if it’s your first clinical trial, you can lean on their experience to drive clinical success and avoid costly mistakes. 

A strong CRO can also provide you with access to their extensive network of contacts in the pharmaceutical and biotech industries, which can be instrumental in helping your drug development efforts.

2) Immediate Access to Patients & Trail Participants

A great CRO fit has the ability to provide a wide variety of clinical trial patients/participants for your clinical study. Discuss the  CRO’s pre-screen process to ensure that you’re enrolling the best possible candidates, which will help you avoid delays in the study due to patient recruitment.  Understand how they meet and monitor enrollment goals and their systems for enhanced patient engagement.

3) Help You Manage Your Budget

A Contract Research Organization can help you stay within your budget by providing accurate cost estimates up-front. This can also help you avoid spending more money than you intended, which can be especially helpful if you are on a tight budget. 

Additionally, a Contract Research Organization can help you speed up the research and development process by providing access to their extensive networks of experts and resources, which can help you further manage your costs. 

4) Access Leading Edge Technology

Regardless of your CRO selection criteria, your final choice needs to be digitally enabled. In this day and age it is probably impossible to overstate the importance of engaging a “Digital-First” CRO.

A strong digital toolset will help your CRO:

• Improve information security, control, and access

• Increase process efficiency and speed

• Improve profitability

• Mitigate risk across the entire ecosystem of the trial

• Facilitate stronger collaboration between EOCs, DMCs, DSMBs, SRCs, Ad Boards

Time is money in clinical trials.  A week delay can cost in excess of $100,000 trial expenses.  On the other side of the ledger, delayed time to market can cost $100,000 a week of lost revenue.  Revenue aside, the benefits to getting life changing treatments to market faster is priceless from the standpoint of patients and their families.  

From a patient safety perspective, strong digital capabilities lead to greater process consistency and communications, both of which contribute to enhanced safety and security.  Understand your CROs full suite of digital capabilities and how they will enhance your study.

Need Help Finding the Right CRO? 

At the end of the day, choosing the right CRO is essential to a successful trial. By partnering with an experienced, reliable, digitally enabled CRO, you can ensure that your trial runs smoothly and efficiently - resulting in better outcomes for patients and sponsors alike.

For more information on choosing the right CRO, contact us today! We have an amazing network of CRO partners. We’d be happy to make introductions and recommendations tailored to meet your specific needs.

5 Common Clinical Trial Management Mistakes (and How to Avoid Them)

Clinical trials are a critical part of the drug development process. Unfortunately, many organizations make common mistakes that can lead to delays or even failures of their trials. Avoiding these mistakes takes awareness, preparation, and an effective trial management process. In this blog post, we will discuss six common clinical trials management mistakes and how to avoid them.

5 Common Clinical Trial Management Mistakes to Avoid

Mistake 1) There is No Project Plan

Project plans are an essential component of a successful clinical trial. At its core, a project plan should include your trial:

• Timeline

• Budget

• Task  List

• Data Collection Strategy

• Oversight plan

• Staffing plan

Timelines and task lists can help your team stay on track so that all tasks are completed on time. An agreed to data collection plan will help ensure your entire team understands the specific data points that need to be tracked. 

Mistake 2) Insufficient Recruitment Plan

One of the biggest mistakes that clinical trial management teams can make is not having a solid plan for patient recruitment. Missing trial recruitment deadlines can lead to delays in enrolling patients, which can impact the overall timeline of the trial. 

For even more insight into developing a recruitment plan, read our recent blog post detailing ways to increase clinical trial enrollment.

Mistake 3) Inadequate System for Patient Tracking and Communications

Another common mistake made by clinical trial management teams is not having a good system to track patient participation and communications. Without these systems, it can be challenging to keep track of each patient’s status within the trial and keep patient engagement high. 

Speak with your management team and make sure they have a system to track patients. You’ll also need to ensure that they have a process and strategy for updating the system regularly. If you must rely on manual systems, investing in exceptional, experienced clinical trial project managers is a must.

Mistake 4) Overlooking Stakeholders

Clinical trials are complex. Frequently you’re juggling multiple entities (EOCs, DMCs, DSMBs, SRCs, Ad Boards, etc.), each representing multiple stakeholders. This can often lead to problems when everyone has a different idea or agenda for how to manage the trial. Stakeholder support and engagement is critical to a successful trial. 

Avoid potential mishaps by having a clear and concise trial management plan that everyone can get behind. Additionally, it is essential to assign specific roles and responsibilities to each partner to help avoid confusion and ensure that everyone knows what they need to do.

Mistake 5) Failure to Invest In Project Management Tools

Project management tools can help you stay organized and on track, essential for any clinical trial. There are many different project management tools available, so find one that fits your needs.

At a minimum, look for clinical trial management tools that:

• Integrate with or serve as your communications hub.

• Accessible via a cloud-based platform.

• Integrate with your existing tech-stack . 

• Can scale with your trial management needs to support multiple, simultaneous trials.

Do your homework and reach out to us.  We’d love to help. The  Cloud Concinnity platform not only does everything described above, it centralizes, simplifies and automates crucial information, processes and tracking that significantly impact the course of a program.

Learn more and schedule your demo here.

By avoiding these common trial management mistakes, you can help to ensure that your clinical trial is successful. If you're not sure how to avoid them, we can help. Reach out to our team of professionals today. 

4 Ways to Increase Clinical Trial Enrollment

Clinical trials are essential to the development of new medications and treatments. However, enrolling participants can be difficult for even the most experienced parties.

The percent of the population that is enrolled in clinical trials is remarkably low. The “high” end of includes the US and the EU at just 5.4% and 4.3% respectively.  From there participation rates drop to around 1% or lower. In addition, a significant percentage of trials do not reach their patient complete participation goals,  nearly half – 40 percent – of cancer trials.  

With both recruitment and retention of adequate trial participants as significant barriers to successful development of new treatments, focusing on better ways to manage clinical trial enrollment is critical. 

This blog post will share four tactics to increase clinical trial enrollment and help you move new treatments and therapies closer to the market.

Increase Clinical Trial Enrollment With These 4 Tactics

1) Set, Measure and Share Enrollment Goals with Partners

You can't improve what you aren't measuring. Before you start integrating new tactics and recruitment efforts, it's critical to establish baseline metrics to determine your enrollment goals. 

At a minimum, you want to ensure you set an initial enrollment goal that aligns with the minimum number of patients required to achieve definitive results. From there, you can establish additional goals. 

Quick tip - be sure all your goals align with your overall objectives. Don't select a number just because,iIt'd be great to hit it. Make sure your enrollment goals have meaning in the trial. 

After defining these goals, please don't keep them hidden away! Communicate them to your team and all partners. Make everyone an active participant in reaching the goal and keep them updated on how enrollment tracks these goals (preferable through a digital platform like Cloud Coconnity).

2) Understand and Plan for Common Objections/Barriers to Participation

By far, the biggest obstacle to driving clinical trial enrollment is trust. If potential participants don't trust any aspect of the trial (from the physicians to the medications), it will be harder to encourage them to participate. 

Trust is a direct result of communication. The more efficient and open you are with your communications about the trial (the independent physicians overseeing the trial, the FDA protocols being followed, etc.), the more likely you will build trust within your recruitment efforts.  

Another way to build trust in your trial is to highlight the role of your oversight committee in your communications. Some potential participants may have a distrust of pharmaceutical companies or of the medical providers associated with them. However, as an oversight committee acts Independently of sponsors and providers, it can help to ease concerns and foster trust in the trial. 

Trust isn't the only obstacle standing in the way of patient enrollment success. Other common obstacles include:

• Location

• Transportation

• Finances

• Competing Obligations

As an exercise, put yourself in the shoes of a potential participant. Identify the potential roadblocks that might interfere with their participation. Then outline how your trial and recruitment plan will address these objections.

3) Optimize Your Recruitment Efforts

Increasing enrollment can be boiled down to one factor for many clinical trials - a high-performing recruitment effort. The better optimized your recruitment strategy, the more likely you are to attract and engage trial participants. Below, we've laid out five key factors of a robust recruitment effort.

1) Zero In On Your Target Demographic

Age/Gender/Medical History are all critical demographic factors in recruiting your ideal audience, but be sure to include additional demographic and psychographic data into your messaging strategy. The more you understand about your ideal participant, the greater the opportunity to tailor your recruitment messaging and trial experience to their needs.

2) Increase Awareness of Your Clinical Trial

No one will be able to join your trial if they don't know anything about it! Dedicate the resources you need to develop and manage a  multi-channel strategy that drives awareness of your clinical trial among your target audience. 

3) Streamline the Application Process

Making a potential enrollee aware of your clinical trial is just the first step in securing a successful enrollment. Cut back on costly ad wastes and reduce form abandonment by streamlining the trail application process and providing a user-friendly enrollment experience. 

4) Provide Incentives for Enrollment

Supercharge your recruitment efforts by offering incentives to participants. As a general rule of thumb, the higher the value of the incentive, the more significant its influence on a participant's decision to enroll. That said, there are diminishing returns. Experiment with various levels of incentives to determine which delivers the best value to your trial. 

5) Engage with Participants Throughout The Trial to Avoid Drop Off

The cost of attracting clinical trial participants can quickly add up. As such, you want to do everything in your power to reduce drop-off and keep retention levels high throughout the trial. One of the simplest ways to improve engagement is to provide consistent communication. The more you're talking with your participants to encourage their ongoing participation, the less likely they will drop off. Consider deploying patient engagement software to do this effectively.

4) Create a Single Source of Truth to Measure and Communicate  Enrollment Information

Siloed data is expensive data.  And it does not provide timely decision support information.  The more barriers to tracking and sharing your data that exist, the less likely your team will be able to promptly analyze and respond to enrollment challenges. Effective measurement and communication of enrollment information requires better access. An integrated software platform can create a single source of truth for decision makers and reporting, as well as eliminate data leakage, loss, and expensive administration. 

Be sure to incorporate a single source of truth for your enrollment data that is available to decision-makers anywhere and anytime. Cloud Concinnity is a powerful cloud-based, integrated platform that drives a higher level of efficiency, speed and risk mitigation while unlocking the value of big data for better decision making.. 

Improve Communication. Enhance Transparency. Drive Enrollment. 

Whether it’s through your Safety Review Committee (SRC), Clinical Trial Steering Committee (TSC) Data Monitoring Committee (DMC/IDMC/DSMB), Clinical Trial Advisory Board, or CRO Oversight,  the more accessible your enrollment data, the more opportunities you have to optimize your recruitment efforts. Strong enrollment comes from having a powerful communication strategy that aligns with data transparency. 

Purpose-built for trial oversight optimization, Concinnity is a single, secure platform where processes that significantly impact the course of a program are managed, executed, and recorded. 

How to Up Your Clinical Trial Data Monitoring Game

Whether you are planning for the data needs of your Safety Review Committee (SRC), Clinical Trial Steering Committee (TSC) Data Monitoring Committee (DMC/IDMC/DSMB), Clinical Trial Advisory Board or CRO Oversight, consistent clinical data monitoring and oversight is critical to a successful clinical trial. Regularly capturing and monitoring your trial's clinical data puts your teams in the position to better understand your trial's status and empowers your team with the information they need to make real-time changes as necessary to optimize your program. 

This post breaks down five steps to defining a successful clinical data monitoring strategy. Following the steps below can save your programs time and money and reduce risk to patients and the program overall.

5 Steps To Defining A Successful Clinical Data Monitoring Strategy

Step 1: Identify Your Most Important Data Points

Clinical trial data can be overwhelming, and it is easy to lose focus on the more essential aspects of the study. A successful data monitoring initiative starts by defining which data points are most important to the analysis, goals, and organizational strategy. 

Consider early the information reporting needs of your oversight teams, both formal and informal, and ensure that the data is timely, reliable, and structured for easy interpretation. Don’t forget to consider relevant data emerging outside of your trial. Data and processes around them spelled out in DMC/DSMB charters and SOPs should be factored into your workflow.

These data points can fall into several categories, including: 

• Patient Count

• Patient Recruitment

• Completed Trials

• Participating Facilities

Step 2: Establish Data Context Format 

Clinical trials increasingly generate more and more complex data. That means more reading and more digesting. This makes developing a way to get a sense of things at a glance more difficult if not more important than ever. The length and content of data requirements for your oversight teams will vary. Committees should define their data content and format needs upfront, bearing in mind the importance of time, trends, and comparisons in their analysis. 

Collecting critical data is essential, but data points themselves aren't a reflection of success or progress. Comparison data points help to provide context to your raw data points. 

By comparing your captured data points to the right metrics, your teams can better determine if the clinical trial is on the path to success or if additional measures are needed to ensure a positive outcome. 

Standard benchmark metrics include: 

• Historical Data & Trends

• Industry or other Comparative Benchmarks

• Internal Goals & Targets

As data presentation is defined, consider the value of providing summary information from past data reviews, interim data, protocol, amendments, recommendations, and any complex medical or statistical issues that influence data interpretation.

Step 3: Implement and Test a Data Capturing Methodology

What good is identifying your critical data points if you're unable to track and capture this information? Before signing off a data monitoring strategy, walk through the collection process for each data point. 

Take the time to identify potential roadblocks and bottlenecks. Are you relying on manual actions to collect your critical data? Or is the collection automated? Where possible, eliminate any manual collection. 

This will help to ensure a smoother data collection process while also eliminating the potential for human errors. 

Step 4: Educating Your Teams on How to Analyze the Data 

Think through your monitoring and oversight teams and identify the individuals that would most benefit from the clinical trial data you're monitoring. Take the time to ensure that they understand how to interpret and analyze the data points they are looking at to support and improve their area of responsibility.

Don’t presume that all participants come to the table ready, willing, and able to understand both the data and the process that they will be engaged in.  Committee members, including DMCs, often have a wide range of experience and training.  Left unaddressed, training needs will impact the cost and success of your program.  

Training programs do not need to be formal or time-consuming. They do have to be well suited to the team or committee itself, so be sure to determine your teams’ training needs upfront.

Critical Components of a Data Training Process Includes:

1. An understanding of why the specific data points have been chosen.  

2. A walkthrough of how the data is collected.

3. Guidance on how the data points relate to established goals/benchmarks.

4. Recommendations on how to analyze the data. 

5. Workflows on any actions needed based on the data.

6. Key elements of data security, including the importance of protecting unblinded data

Step 5: Select The Right System for Your Data Needs

The clinical trial oversight ecosystem is complex and highly regulated. Unfortunately, the work of most monitoring teams and committees is mired in 20th-century point solutions - creating data and process insecurity and variability. 

These systems are often home-grown, dated & generic, disconnected, highly manual, and error prone. They increase costs, risks & delays at a time when we need trials that are fast, safe, and efficient. 

Clinical trial oversight depends on accurate, up-to-date information that is securely and quickly available to decision-makers. Centralizing this information securely in the cloud means the right people will have instant, 24/7 access to the right information they need. 

What’s more, rather than trial updates needing to be sent over insecure connections, the information can be uploaded or updated automatically, when it’s ready, and is immediately available. At the same time, the information is more private and protected than ever because it is only being shared within a single, secure platform that has high-level privacy protection.

Improve Your Clinical Trial Data Monitoring with Cloud Concinnity 

Cloud Concinnity is an integrated platform that centralizes, simplifies, and automates control of data, communications, process management & reporting while unlocking the value of big data. Systems like Cloud Concinnity can make it easier for your team to review the data collaboratively while providing a centralized hub for data capturing processes, measurement strategies, and reporting. 

Data collection, monitoring, and reporting are critical to a successful clinical trial. By taking the time to define your data collection intentions, you're more likely to experience long-term clinical success.

The Concinnity Company Partners with Neuren Pharmaceuticals

“We are extremely happy to be Neuren’s partner in improving the lives of people with neurodevelopmental disabilities” said Nancy Falls, Concinnity Company CEO. Neuren Pharmaceuticals is developing new therapies for highly debilitating neurodevelopmental disorders that emerge in early childhood. Currently there are no highly effective or disease-modifying drugs approved for these conditions. Because these are serious medical conditions with unmet need, speed, as well as quality, is of the essence.

In addition to seeking regulatory fast tracks, Neuren sought to ensure superior security and efficiency in its clinical trial oversight process.  In search of the best software solution for managing these important clinical trial oversight committees, Neuren found The Concinnity Company and its Cloud Concinnity® platform. 

“Concinnity is extraordinarily functional and comprehensive clinical trial oversight software: a single, secure platform where all meetings, documents and processes can be centralized, automated, monitored and generate a complete audit trail.” said James Shaw, Vice President, Clinical & Regulatory Operations. “By partnering with outstanding CROs and Concinnity, we can be assured of speed, security and efficiency in our oversight processes.”

Neuren’s  use of Concinnity’s innovative software supports the Data Safety and Monitoring Committees’ oversight of 3 trials testing the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with  3 syndromes: Pitt Hopkins Syndrome, Phelan-McDermid Syndrome and Angelman Syndrome. Implementation of the Cloud Concinnity platform is expected to reduce any administrative burdens so that the DSMC can complete its work securely, thoroughly and quickly by improving  meeting coordination, document sharing and general workflow practices.

“The future of clinical research depends on the kind of improvements in information and communications access and control, process consistency and tracking and outcomes transparency that are only achievable with smart technology,” said Falls. “This is especially true trials for our most vulnerable patients, ones that involve complex or adaptive trial designs, tight monitoring of dosing escalation, the analysis of multiple and complex data streams, and rigorous regulatory involvement.”

About Neuren:

Neuren is developing two new drug therapies to treat multiple serious neurological disorders that emerge in early childhood. The lead drug compound, trofinetide, is currently in a Phase 3 clinical trial for Rett syndrome and has completed a Phase 2 clinical trial in Fragile X syndrome. Both programs have been granted Fast Track designation by the US Food and Drug Administration (FDA). Neuren has granted an exclusive licence to ACADIA Pharmaceuticals Inc. for the development and commercialisation of trofinetide in North America. Neuren plans to initiate Phase 2 trials for a second drug candidate, for each of PhelanMcDermid syndrome, Angelman syndrome and Pitt Hopkins syndrome in 2022. Because of the urgent unmet need, all five programs have been granted “orphan drug” designation in both the United States and the European Union

Why Adaptive Design Clinical Trials Demand Stronger Digital Capabilities

Clinical trials are moving faster than ever, and decisions about starting, stopping, continuing or changing protocols are happening in real time, across geographies. It is critical to have a digital home that centralizes, simplifies and automates all of the crucial information, processes and tracking that can significantly impact the course of a program. 

Conventional trial design and oversight has been pushed to evolve and change in the two years since the FDA first released their “Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry,” and the Covid-19 pandemic has only hastened the shift, pushing adaptive trial design to the fore. 

As adaptive trial design emerges as part of the new normal, clinical trial oversight design must embrace smarter software like Cloud Concinnity® to adapt and thrive.

Adaptive trial design takes clinical research to the next level, yet it presents some key challenges that come with speed and responsiveness. Challenges and demands like 1) More Meetings, 2) More Decisions, 3) Tighter Timeframes, 4) More Complex Data, 5) More Data Streams and 6) Higher Stakes come part and parcel with adaptive trial design.

For oversight teams, smarter software holds the key to addressing and solving many of these challenges. Here’s how: 

6 Ways Smarter Oversight Software Meets the Demands of Adaptive Trial Design

1. More Meetings? Smarter Software Means Better Process Automation

Adaptive trial design means more data and more decisions to make — and that means more meetings to discuss and make those decisions. With an oversight team spread out across the world and across time zones, manually managing standard operating procedures and charter mandates can create significant delays. Using a platform that automates meeting management end to end gives administrators broad and deep capabilities like automated scheduling, invites, reminders, data aggregation and decision documentation making less work for everyone, and more time for deep thinking. 

2. More Decisions? Smarter Software Lets You Stay Connected, Secure & Well-Informed

The data, information and consideration it takes to successfully oversee and manage an adaptive trial means lots of reading and questions. Every bit of that information must be kept confidential, which is easy with smart software that has the most advanced security protocols. What’s more, smart software can keep all communication during the decision-making process secure, so there’s no need to risk email, text, or video chats that could be hacked or leaked. 

3. Tighter Timeframes? Smarter Software Centralizes & Streamlines Everything 

We know that “Adaptive clinical trials can be completed sooner than trials with conventional (non-adaptive) designs,” so there is every reason to expect this faster, more nimble trial design to be widely adopted. And with the potential for speed comes tighter timeframes. Centralizing access, process, and outcomes means everyone on the oversight team need only check and stay updated on a single platform. Centralized means simpler, and simpler means faster. In addition, getting together as a team simultaneously to discuss everything, every time can be unrealistic. That’s why the secure, asynchronous communication that smarter software offers is critical. Share documents, have conversations and send messages across time zones and geographies. 

4. More Complex Data? Smarter Software Simplifies Everything with a Master Dashboard

Adaptive trials deal with and generate more complex data than conventional ones. That means more reading and more digesting, but it doesn’t change the fact that we all need a way to get a sense of things at a glance. A single, secure hub for the aggregation, review and submission of data for oversight committees, sponsors & regulators makes that possible with a master dashboard and analytics. Customizable, global dashboards that aggregate key information within and across studies gives unprecedented visibility to key study results and metrics 24x7.

5. More Data Streams? Smarter Software Offers Powerful Data Integration

Adaptive trial design means more data streams, more information, and more decisions to make. A platform that is integrated across the eclinical ecosystem ensures data integrity from trial planning all the way through regulatory approval and beyond. Confidently create a single source of truth for your trial oversight activities that securely connects all points of information, from EDC to eTMF. 

6. Higher Stakes? Smarter Software Delivers End to End Process Management

“Unlike conventional designs, where the learning typically occurs after the trial is completed, adaptive designs intend for continual learning as the data accumulate.” Continual learning and adaptive decision-making means more to manage, and that’s why the process management engine of smarter software is so critical. End to end process management is the ideal vehicle to power continual learning for a dispersed oversight team.

In the end, it’s clear that adaptive trial design is the way of the future, which means oversight teams will need to be more adaptive as well. Smart software is the only answer that lets teams step up to the next level while also maintaining or improving quality. 

6 Data Security Benefits We Deliver for Clinical Trial Oversight

At Concinnity, our #1 concern is data security for clinical trial oversight. 

As the world woke up to the dawning new normal of 2022, we saw thought leaders across healthcare pointing toward a digital future. Aman Khera, the Global Head of Regulatory Strategy at Worldwide Clinical Trials, cited “Digital Health” and digital transformation as the top trends shaping clinical trial regulations in 2022, noting that everyone from the WHO to the FDA and EMA are looking closely at how digitization tools should be used, and at how data is stored and used. BCG recently proclaimed that healthcare’s new reality is dynamic, digital, and here to stay. 

Security for digital data and communication is what makes the digital future of clinical trial oversight possible.

At Concinnity, we have focused on data security from day one. We know that digital security for all stakeholders at every level of the process — from study sponsors and CRO’s all the way down to each individual study participant — is an inherent and primary need to pave the way for this digital future. It is our security features that make our platform a game-changer, by making Cloud Concinnity the  most secure platform available for clinical trial oversight management.

Concinnity is structurally designed to adhere to the highest standards of data security, including the special protections required by law for health information by HIPAA and other related regulatory requirements. 

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Here are the top 6 data security benefits we deliver for clinical trial oversight:

1. Separate Workspaces for Blinded and Unblinded Study Teams

   At the very core of clinical trial oversight is the need for certain iron-clad data separation. To ensure this, Cloud Concinnity creates a “physical” separation of blinded and unblinded data that eliminates the risk of any stakeholder sharing unblinded information. In short, we make it virtually impossible for oversight data accidents to happen. 

2. Superior UI/UX (usability) that Improves Security

   The simple, clean, intuitive user interface that makes Concinnity a joy to use also makes it more secure. Our superior UI/UX and deep structural platform integrity dramatically reduces any risk of user error and of any individual using the software incorrectly or accidentally going around the system. 

3. Patent Pending Workflow Engine that Safeguards Processes and Data

   We understand that procedures and processes are as important to data security and compliance as software structure. Manual processes by nature are subject to human error and vulnerable to the loss of institutional knowledge during staffing transitions. Our proprietary workflow engine includes features that easily automate best practice processes across a portfolio of studies, protecting data and reducing the risk of variability or non-compliance. 

4. Comprehensive Oversight Solution Protects Patient/Sponsor Data

   We built capabilities and productivity integrations that allow participants to do all of their clinical trial oversight work on a single, secure platform. This eliminates the significant risk introduced by transmission of sensitive information into and out of various non compliant applications, from email on multiple servers to scheduling, video conferencing, eSignature and document editing apps where data insecurity is rife.

5. Integrated Platform Ensures Data Integrity from trial planning all the way through regulatory approval and beyond

   Confidently create a single source of truth for your trial oversight activities that securely connects all points of information, from EDC to eTMF. Robust data integrations remove the risk of data loss, leakage, and unblinding. Automated data integrations protect clinical trial data and security on the way in, eliminating the need for manual or episodic uploads. Direct integrations with reporting and document management systems protect critical decisions and auditability on the way out. 

6. Regulatory Compliance That Goes Above and Beyond

   Cloud Concinnity is compliant with all ​​21 CFR Part 11 regulations, and maintains a host of further regulatory compliance credentials. We maintain SOC2 compliance, and use further information security elements or setup elements like 2-factor authentication for login, plus role-based and configurable permissions to control access to specific data/content/information.

The bottom line? Cloud Concinnity is by far the most secure choice to manage clinical trial oversight operations, and the only clinical trial oversight software on the market equipped to fully make the digital future of clinical trial oversight possible. 

The Year Ahead: Big ideas for the future of clinical trial oversight.

What does it take to build the future? What mindset does a team need to create breakthrough clinical trial oversight software that will impact millions of patient outcomes?  

It takes innovation, commitment & the courage to lead. 

While the world continues to wrestle with Covid, we at Concinnity have grown even more committed to our role in bringing life changing treatments to market more quickly, safely and efficiently. The future of clinical trial oversight is undoubtedly digital, and utilizing smart software to facilitate information access, process control and outcomes visibility is imperative. 2022 will be a pivotal moment for our industry. We feel like it is our moment. Why? As one of our team posted this week: 

“The challenges of the clinical trial oversight ecosystem feel like they were created for us; a place where we can be innovative and idealistic where the ceiling will be created and determined by us.”

To start off 2022, we asked ourselves: What excites us about the future of clinical trial oversight? There were too many good ideas and insights to publish everything, so we’re offering a condensed look behind the scenes at what our team is thinking. 

Here are a few of the big ideas driving our work as the calendar turns to the new year:

DOING OUR PART TO HELP HEAL THE WORLD

Given that the revolution/evolution of the clinical trial ecosystem continues, we’re excited and motivated by the impact Concinnity's technology can make on helping to heal the world. We'll be providing crucial services to pharmaceutical companies and DSMBs that will be called upon to make faster decisions about the safety and efficacy of clinical trial results.

MAKING A DIRECT HUMAN IMPACT

We are proud to be part of an industry that is making a direct impact on the human race. One of our customers is the first pharmaceutical company ever to show positive results in a phase 3 neurological disorder. We are delighted to be working with such passionate, innovative professionals. Need we say more?!?

HELPING CUSTOMERS DO MORE WITH LESS

In the face of shrinking support resources across industries, we're poised to enable our customers to do more with less.

MAKING TECHNOLOGY THAT CHANGES THE WORLD

As Covid becomes endemic and more a part of a new normal, we anticipate seeing a rapid uptick in drug trials. We see this year as the time when both sponsors and the CROs recognize the need to use technology to make the management of DMCs both more secure and more efficient.

In the year ahead, we know that changes and challenges to the industry will continue. But the good news is, we are powering the smart, digital future of clinical trial oversight with the most functional and comprehensive clinical trial oversight software on the market. And thousands of women and men across the globe are committed to the success of trial operations in the midst of unprecedented hardship.

Our belief in the power of our collective hard work and innovation gives us faith in our shared future. We believe we will look back on 2022 as a year of great progress. Let’s lead and innovate together!  

Learn more about how Cloud Concinnity can support your clinical trial oversight. 

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Want more forward-looking insight? Here’s a sample of our deepest insights on what 2022 will bring: 

A Look Ahead: 4 Clinical Trial Oversight Trends That Will Guide 2022 and Beyond

Thinking Ahead: 5 Post-Pandemic Priorities for Clinical Trial Oversight

Beyond COVID: 3 New Standards for Clinical Trial Oversight