Improving Safety Reviews in Clinical Trials Through Tech-Enabled Centralization

Imagine having all your data seamlessly integrated in one place! A recent Oracle survey revealed that 50% of clinical data managers rely on up to five different data sources, making it challenging to draw meaningful insights from trial data. The complexity of managing multiple platforms creates data silos, isolating information and making it difficult for data managers to achieve a comprehensive view. This fragmentation not only increases the risk of data inconsistencies but also slows down the decision-making process, hampering the overall efficiency of clinical trials. 

Beyond data consolidation challenges, the use of disparate systems leads to broader operational complications. Disparate solutions designed for specific tasks are often not scalable or adaptable to new technologies, requiring costly modifications to remain compliant with evolving regulations. Additionally, managing communication through unsecured methods like email increases the risk of data privacy issues—a critical concern in today’s digital transformation in healthcare, and corporate cross-contamination. This fragmented user experience undermines operational quality and increases inefficiencies, as more time spent on management and training drives up costs and reduces trial management effectiveness. However, with Cloud Concinnity®, costs could potentially be reduced, leading to a 30-50% ROI and enhancing overall efficiency.

The pharmaceutical industry is moving away from traditional point systems—discrete tools designed for individual tasks—towards centralized cloud platforms. These unified platforms centralize all trial-related data, eliminating inefficiencies and improving data integrity. This shift represents not just a technological upgrade but a fundamental rethinking of how trials are managed, offering the potential to enhance overall research quality. 

Cloud Concinnity® is at the forefront of this transformation, serving as a centralization hub for safety review activities. By offering streamlined access to essential tools from any location, Cloud Concinnity effectively resolves the complexities of managing multiple disparate systems. Its key features include:

  • Automated Task Alerts: Keeps teams aligned with timely reminders, ensuring tasks are completed efficiently and on schedule

  • Time-Saving Safety Listings: Streamlines safety data review, reducing manual effort and speeding up the process

  • Document Distribution via Standard Workflows: Automates the distribution process with consistent workflows, minimizing administrative workload

  • Role-Based Access Control: Ensures secure access control and seamless user transitions while minimizing data breach risks. Cloud Concinnity also includes a 21 CFR Part 11 compliant login with 2-factor authentication for enhanced data security

  • Robust Notification Center: Sends automated reminders to keep teams informed, enhancing coordination across dispersed teams

  • Centralized Dashboard: Provides a real-time overview of all studies and processes

Cloud Concinnity’s centralizing features offer several overarching benefits, like.

  • Seamless Collaboration: Teams across different locations can collaborate in real time with unified access to up-to-date data, speeding up decision-making and fostering greater coordination

  • Data Accuracy and Consistency: Centralized management eliminates redundancies and ensures data integrity, so every site operates on accurate, updated information without duplication or confusion

  • Data Safety: By mitigating breach risks and maintaining regulatory compliance, Cloud Concinnity safeguards sensitive information, ensuring secure data handling throughout the trial process

  • Faster Execution: With automated alerts and faster safety reviews, Cloud Concinnity reduces the time spent on manual tasks, accelerating the clinical trial process 

  • Cost Savings and Resource Optimization: By reducing administrative burdens and avoiding duplicative work, Cloud Concinnity helps streamline operations, ensuring that trials remain on budget while improving overall outcomes


There has always been a clear need for centralized platforms in clinical safety review processes, but sponsors were hesitant to adopt them due to various factors, particularly data privacy concerns. Impact of COVID-19, however, drastically changed this perspective. With social distancing and remote work becoming widespread, the limitations of fragmented systems became apparent. Centralized platforms quickly emerged as the more reliable and efficient solution, offering streamlined data handling, and a cost-effective approach. As a result, leveraging centralized technologies has become critical for the future success of clinical trials. 

Looking ahead, the future of clinical research will be increasingly shaped by the integration of advanced technologies, with AI in Healthcare and machine learning playing a central role. These advanced technologies will enable automated data quality checks, statistical analysis, and visualization techniques, rapidly identifying patterns, inconsistencies, and missing data. Centralized platforms, powered by AI and automation, will play a pivotal role in making clinical trials faster, more reliable, and more secure, ensuring that research adapts to the growing complexities of the healthcare landscape.

Transforming Clinical Trials’ Coordination Through Automation

Transforming Clinical Trials’ Coordination Through Automation

Discover how automation in clinical trials tackles delays and inefficiencies by streamlining data management, enhancing collaboration, and ensuring regulatory compliance for independent safety review committees. Learn how this shift optimizes resource use, accelerates time-to-market, and supports more reliable trial outcomes

Platform Update: Improvements to Tasks and Workflows

As the premier clinical trial oversight solution provider, we welcome feedback from our active user base and use this feedback to enhance and improve our cloud-based platform. We are proud to announce improvements to the tasks and workflow functionality within our Cloud Concinnity Platform.  

Time to Get To Work With UI/UX to The Tasks Functionality 

Tasks are a critical feature and function of the Cloud Concinnity Platforms. In an increasingly decentralized space, our task functionality empowers teams with insights into each other’s workloads along with the collaboration tools to meet their obligations. 

We’ve made a host of updates to the Tasks user experience that makes managing and creating tasks now, even more, user-friendly for our current and new customers. How? 

  1. We’ve eliminated clicks - now each task’s details are visible from the Task page.

  2. We’ve improved the time it takes for users to see a task assignment. 

  3. We’ve improved the viewability of tasks by putting all task details front and center for the users. 

The result? A more intuitive user experience that eliminates a bit of user friction while providing a heap of improved usability. 

Poll Your Patients - Votes, and Surveys Are Now Easier to Conduct

Greater visibility in Task details now includes any vote or survey details. These can now be displayed on the task itself, eliminating the need to open a separate survey or vote document to view the results. This makes it much easier (and faster) for the user to take necessary actions based on the results of the vote or survey.

What Do These Improvements Mean For the Team?

  • Easier time collaborating across tasks. 

  • More efficient implementation of surveys or vote findings.

  • Swifter response and improved work output.

Now your team can spend less time digging for task details and more time getting to work completing your next clinical trial. 

Cloud Concinnity is Built Specifically for Clinical Trial Oversight Committees 

At Cloud Concinnity®, we’ve seen firsthand that the future of clinical trial oversight is digital, which is why we are currently working on functional improvements to the platform. If you haven’t yet experienced Cloud Concinnity® customers, now’s the perfect time to see for yourself how our premier platform can help you 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 Best Practices to Improve Clinical Trial Oversight in Hybrid and Decentralized Clinical Trials

The clinical trial field is changing rapidly. Some of these changes have been spurred by the pandemic, while others have been in the works for several years as technologies and trial needs evolve. One of the most recent changes is the rise in hybrid and decentralized clinical trials. In this blog post, we summarize five tools and tips that can help the best practices you need to support clinical trial oversight across a hybrid decentralized clinical trial.

5 Tips and Tools to Improve Clinical Trial Oversight in Hybrid and Decentralized Clinical Trials 

As you may be aware, hybrid and decentralized clinical trials allow researchers to successfully conclude a clinical trial while conducting it partially or primarily remotely. What you may not know is that a recent EY-Parthenon survey found that respondents estimate that 50% of clinical trials will be hybrid or decentralized by 2024. While hybrid or decentralized clinical trials bring with them a host of benefits, they do introduce new difficulties based on their differences from traditional clinical trials. 

Here are five best practices to keep in mind to help mitigate these differences and enhance the benefits of hybrid and decentralized clinical trials:

  1. Centralize Your Data Collection 

  2. Segregate Blinded Vs. Unblinded Data

  3. Communication is The Key to Success

  4. Use Software To Automate Meeting Scheduling

  5. Standardize Your Reporting

Centralize Your Data Collection

Hybrid or decentralized clinical trials aren’t perfect, and their most decisive benefit – the remote aspects that benefit the patients and the researchers –requires thoughtfulness and preparation to empower your team to collect and store critical clinical data.

As a starting point, we recommend selecting a centralized data collection tool that includes:

  • A cloud-based system that can be accessed from each location. 

  • Strong security measures to ensure that only authorized.

  • An intuitive user experience that promotes adoption across all of your clinical sites. 

If you’re on the hunt for just such a system, The Cloud Concinnity Platforms has you covered. This tool was built specifically for clinical trial oversight committees and integrates with your trial’s electronic data communication platform to help centralize and systemize your data. You can learn more and sign up for a demo here.

Automate Blinded Vs. Unblinded Data Segregation

As your clinical trial is taking place across a hybrid or decentralized landscape, it’s critical to introduce automation to help you manage the segregation of blinded and unblinded data. Not only does automating data segregation replace the work that goes into the manual management of sharing blinded/unblinded data with stakeholders and participants, but it also helps to mitigate any risks that can come from manual data sharing and reporting. 

Communication Is the Key to Success

Since your research team will be communicating remotely - across cities and even time zones - strong communication guidance is a necessity for success. Given the remote aspects of hybrid decentralized clinical trials, you should anticipate higher levels of asynchronous communication – note review, comments, emails, etc. We recommend utilizing a system like Cloud Concinnity to help support these needs.

Use Software To Automate Meeting Scheduling

A key challenge for managing hybrid and decentralized trials is that your administrative team is disconnected across locations, which means getting meetings scheduled can be a bit of a pain. There’s countless back and forth, which can introduce costly delays. Instead, we recommend using available tools (like Cloud Concinnity) to automate meeting scheduling and remove the friction that comes with manually scheduling meetings. 

Standardize and Batch Your Reporting

By now, you should be aware of the benefits of centralizing your data and using automation to help eliminate some of the friction that can come from hybrid or decentralized clinical trials. Work with your team to standardize the reporting that you deliver to the clinical trial oversight committee, then use a system (like Cloud Concinnity) to automate and batch report creation. 
To best implement your next hybrid or decentralized clinical trial, you’ll need software like Cloud Concinnity, which offers remote data collection all in one place, along with the ability to communicate efficiently and virtually.

For a free demo, please reach out to us today. We’re here to help.

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.

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.