5 Ways To Streamline Virtual Trial Management With The Right Tech Stack

As the world becomes increasingly reliant on technology, it is no surprise that the clinical trial field is following suit. Virtual trials, also known as remote or decentralized clinical trials, involve using technology to collect data and monitor patient health remotely instead of in a traditional brick-and-mortar clinic setting. Successful virtual trials are built on a technology stack that meets the critical needs of virtual trials. This blog post outlines five essential technical requirements that your tech stack must support to drive successful virtual trial completion. 

The Advantages and Risks of Virtual Trials

While virtual trials have been around for several years, their use has significantly increased during the COVID-19 pandemic. With social distancing measures in place and concerns about exposing vulnerable patients to potential viruses, many pharmaceutical companies have turned to virtual trials as a safer alternative. 

Not only do virtual trials offer a solution to current crises, but they also bring with them several advantages. These include increased diversity in trial participants, reduced costs, faster recruitment and data collection, and improved patient compliance and satisfaction. 

However, virtual trials do come with some challenges. These include the potential for technical issues or data inaccuracies, difficulties in monitoring adherence to trial protocols, and a lack of hands-on interaction between researchers and participants. 

Despite these hurdles, it is clear that virtual trials are here to stay. As technology advances and more companies turn to remote options, we can expect to see even greater use of virtual trials in the future.

5 Ways to Use Technology to Streamline Your Virtual Trial

Virtual Oversight and Monitoring

Virtual clinical trials require efficient and secure methods for remote site oversight and monitoring. This includes virtual visits, remote source data verification, and virtual document management. 

When building your virtual trial tech stack, it’s critical that you include a system that can manage each of these core needs. As a best practice, ensure you choose a system that is:

• Easy-to-use.

• Effective at meeting your core oversight and monitoring needs.

• Bug-free (or as close as you can get). 

Virtual Patient Recruitment, Treatment, and Monitoring

Your virtual trial tech stack must provide a platform for virtual patient recruitment, treatment, monitoring, and adherence. This includes online questionnaires, eConsent forms, remote data collection, and virtual appointment scheduling. 

One key aspect is having a platform that allows for accessible communication and information sharing between patients, healthcare providers, and researchers. This can involve video conferencing capabilities, secure messaging systems, and electronic data transfer. 

Additionally, a robust remote monitoring system is crucial for properly tracking and documenting patient progress without in-person visits. This may involve wearable devices or mobile apps for self-reporting symptoms and collecting other health metrics. 

Virtual & Asynchronous Oversight Ops, from Safety Programs and Committees to DSMBs

Virtual clinical trials require virtual and asynchronous oversight operations, including virtual safety programs and committees and remote Data Safety Monitoring Board (DSMB) meetings. 

Your tech stack should support these functions through: 

• Streamlined Communication.

• Process Automation and Review. 

• Secure Data Sharing Capabilities.

Additionally, it is crucial to have a solid plan for training all team members on using the selected technology. This will ensure smooth implementation and efficient virtual operations during the clinical trial. Ultimately, investing in the right technology for virtual and asynchronous oversight operations can make all the difference.

Easier & Greater Access to & for KOLs

We’ve written before about the critical impact that Key Opinion Leaders (KOLS) can have on your trail. You can read more about our tips on attracting and retaining KOLs.

The important thing to keep in mind when it comes to supporting your KOLs is that your tech stack can either be a benefit or a liability. Your virtual trial tech stack should help to reduce the friction experienced by KOLs in virtual trials. 

Some examples of friction reduction include:

• Using collaborative scheduling to streamline meeting schedules. 

• Eliminate an overuse or overreliance on paperwork.

• Support asynchronous communication. 

Real-time Study Metrics & Performance Reporting

Finally, your virtual trial tech stack should include real-time study metrics and performance reporting tools. This allows sponsors to identify any potential issues or roadblocks quickly, and take immediate action to address them. It also helps ensure that data is consistently and accurately captured, meeting regulatory compliance requirements.

Consider implementing an eSource system for the electronic collection of subject data at the point of care and a centralized data management platform to aggregate and analyze this information. This type of technology allows for more efficient virtual monitoring visits, where remote reviewers can easily access all necessary study data in one place.

You can drive successful remote clinical trials by ensuring that your virtual trial tech stack meets these five essential needs. If you’re looking for a jump-start for your virtual trial management, consider Cloud Concinnity. 

The Cloud Concinnity platform was built to meet the specific clinical trial management needs of CROs,Sponsors and oversight committee members (DSMBs, DMCs, SRCs, etc). Our cloud-based systems provide vested trial parties with a centralized communication, collaboration, and data management tool. 

Learn more about how Cloud Concinnity can help drive success for your virtual trial. Schedule a demo today and get started.

5 Reasons Why Your General Counsel Will Love Cloud Concinnity®

3 minute read

As the role of the General Counsel evolves, the technology needs of GCs evolve as well. It is no longer enough to weigh in when the business team identifies the need for contractual, compliance or regulatory assistance; a GC must be informed, proactive and a driving force behind critical conversations.

We know that the earlier a GC gets involved in a project, the better the likelihood of avoiding legal repercussions. And we also know that in order to be counselors in the truest sense of the term, GCs need to offer innovative strategies that legally support the business goals. Indeed, savvy legal advice is critical business acumen.

Here is why your Legal Team will love Cloud Concinnity®.

1. Discovery Prepared. Keeping up with regulatory requirements and corporate compliance, let alone preventing and managing litigation, is a complex, consuming and resource-demanding task. That’s why we’ve automated documentation of regulatory compliance in Cloud Concinnity®. Instead of having to gather records from disparate email or messaging accounts and calendars, every task accomplished, every meeting and message on topic is automatically logged in a searchable database. When you need to demonstrate compliance with regulatory or litigation duties of care, it’s where you can easily find and produce it. When you need to prove that your board has exercised its fiduciary duties in the face of potential litigation, the records are there.

2. Simplified Oversight. We prioritize and simplify oversight. Your board and your company’s senior leaders need to discuss governance, risk, and compliance (GRC) & boardroom matters at a high level, with the reassurance that they have the information they need, when they need it. Our ability to automate workflows that both conduct and document the oversight of GRC activities enables the board to oversee management’s reporting systems that spot anomalies and red flags. There is no other tool out there designed specifically for these needs: secure, documented and simple. With Cloud Concinnity®, GCs and other senior users monitor mission-critical activities and communications on a single dashboard, fed by data sources of your choosing. No more silent risk creeping up when you least expect it.

3. Automated Processes. Certain seasons of the year mean sleepless nights and stressful weekends for the entire executive team, but especially the legal team. So we designed Cloud Concinnity® to make it easy to get all those whose participation is needed on the same page about key filing dates for regulatory compliance and enterprise risk management. Work that can be automated is made easier. Rather than spending hundreds of hours manually producing and managing tasks, our software transforms checklists and spreadsheets into automated workflows. You can reliably simplify the monumental task of coordinating and obtaining everything you need from everyone in the company on schedule. This will free up swaths of time and mental energy so you can focus on substance, rather than rushing to meet due dates every year.

4. Proactive Prevention. GCs have historically been the “defenders in chief,” and that role will of course continue to be as important as it has ever been. But in today’s legal climate, getting out in front of risk is the way to win. Because Cloud Concinnity® is designed for high level conversations, it is a powerful tool to create the tone at the top, which will drive the prioritization of compliance throughout. Setting the bar for ethical and legal compliance, and initiating important risk conversations that are months or years ahead of others in your marketplace is much easier when there is a tool that exists for just such conversations. The habit of high level conversations means more team agreement and better proactive communication around identifying and neutralizing risks.

5. A Place for Culture. Considerations about having a healthy corporate culture have never been more critical — even when they are not popular. And for better or worse, it often falls to GCs to bring up thorny topics. Conversations about issues like sustainability, #MeToo, trade policy and diversity have always been important, but in today’s climate, senior leaders ignore or minimize them at their peril. Again, creating a place where those conversations can be ongoing rather than periodic, and can make room for all voices over a period of time means that those conversations can evolve and make room for the research and interactions they truly need. Corporate culture, the company’s reputation, and things that may be “legal” but not advisable in light of stakeholder interests all find a home here as well.

As GCs and legal teams become more visible and influential with the business leadership, we are proud to provide a technology that powers real change. If your senior leadership team is ready to step into discovery preparedness, simplified oversight, proactive prevention and better conversations about culture, we’d love to hear from you.

Click here to send our co-founder and CLO Heidi Allen an email and hear about why she has made Cloud Concinnity® her mission, or click here to watch a brief overview of Cloud Concinnity®.