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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
Clinical trials are essential to the development of new medications and treatments. However, enrolling participants can be difficult for even the most experienced parties. This blog post will share four tactics to increase clinical trial enrollment and help you move new treatments and therapies closer to the market.
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. For oversight teams, smarter software holds the key to addressing and solving challenges like 1) More Meetings, 2) More Decisions, 3) Tighter Timeframes, 4) More Complex Data, 5) More Data Streams and 6) Higher Stakes that come part and parcel with adaptive trial design.
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.
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.
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.
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.
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.
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.
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.
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.
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:
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.
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?!?
In the face of shrinking support resources across industries, we're poised to enable our customers to do more with less.
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.
A Look Ahead: 4 Clinical Trial Oversight Trends That Will Guide 2022 and Beyond
Thinking Ahead: 5 Post-Pandemic Priorities for Clinical Trial Oversight
The opportunity for digital cloud transformation to impact the clinical trial oversight ecosystem has arrived, offering myriad advantages to sponsors, CROs and DSMBs. Those who start now can still be ahead of the digital curve. Today, we look at 3 advantages that cloud transformation offers to clinical trial oversight players, if they anchor their transformation in enterprise, integrated platforms.
COVID-19 has deeply impacted every aspect of clinical trial oversight, but we are only now beginning to explore its ongoing impacts and effects. In looking at “the next wave of healthcare innovation,” McKinsey zooms in on how innovation can transform longstanding inefficiencies, and how technology is the key to unlocking a future that accelerates that innovation.
It is clear that innovation driven by digital transformation will drive the future of clinical trial oversight. Not only will the coming years be challenging to navigate, they will also push all of us to work together to create a truly innovative clinical trial oversight ecosystem.
Today, we highlight 3 areas where innovation is called on to address the ongoing impact of COVID-19 across the clinical trial oversight.
While research and study protocols typically only change over long periods of time, when COVID-19 arrived in 2019, these protocols and study models had to change literally overnight. The answers about how best to manage oversight of a study in today’s environment are still far from settled.
Oversight processes need to be optimized for efficient, effective remote work. Optimizing oversight processes will support getting new drugs to market faster, thereby positively impacting patients down the line. At the same time, optimizing oversight processes for remote work creates countless opportunities for reducing costs. This is where oversight innovation -- driven by smart technology -- can impact the bottom line of every stakeholder in the process.
Understanding that smart technology will drive the necessary oversight innovation is one thing. Being the group who researches, understands, and chooses the right solution is the real step that will set you apart from the pack. And staying a step ahead of competitors is critical. We have a whitepaper full of deep insight into exactly why and how.
Getting started in 2021 on the innovations that will serve you in 2022 and beyond is the key to getting ahead of the pack. It is tempting to employ short term tech solutions that work “for now,” but it is the stakeholders who choose to plan for the ongoing impact of COVID-19 who will thrive in the next chapter of clinical trial oversight.
Smarter software and innovative approaches to the impact of COVID-19 does not stop with optimized processes and market advantages. COVID-19 is also impacting the regulatory and compliance environments of every industry.
We need innovative ways for oversight committees to stay updated personally and as a group on these changes. And, we need innovative ways for remote oversight teams to quickly get on the same page about how study protocols and other procedures and requirements for final documents are changing. All of this is best accomplished with smart technology.
The future of clinical trial oversight will be driven by innovation driven and digital transformation. will drive the future of clinical trial oversight -- it’s the only way to stay on top of the ongoing impact of COVID-19.
How is your team jumpstarting oversight innovation in your ecosystem?
Click here to learn more about how
Cloud Concinnity can support your clinical trial oversight
