Uncertainty is part of the “new normal” for clinical trials, so anything an organization can do now to help stabilize operations and maximize revenue potential in the new year is extremely important. When it comes to clinical trials during the pandemic, staying operational has often meant ensuring the ability to perform tasks remotely, while finding ways to reduce costs. With COVID cases on the rise, being ready for the coming year needs fast decision making now. Given that it is difficult to work remotely without the right secure and compliant trial workflow technology, below is a guide to some key enabling technologies, their benefits, and what must be overcome to ensure timely deployment:
Clinical Trial Management Systems
Many teams running clinical trials are using a CTMS systems such as CC CTMS acquired before the pandemic to manage what is undoubtedly a complex process. Such a comprehensive system provides tools for multi-site/trial study builds and management, recruitment, enrollment, scheduling, patient management, finances, reporting, and much more. Modern systems being cloud based, many research sites were able to switch many tasks to remote workflows rather quickly. In addition, users of such a comprehensive CTMS also have imbedded remote workflow options for instant payments, two-way texting, and secure video conferencing, which are even more valuable in the “new normal”.
The few organizations unable to acquire a CTMS prior to the pandemic are now scrambling to secure a solution, though the mere thought of deploying such a system amidst the current reality can be daunting. Is there an alternative? The simple answer is that it depends. Though there is no substitute for having a fully functional CTMS, there are big differences in how smoothly a CTMS can be configured and deployed. That is why it is important to obtain a CTMS from a vendor that cares enough to not only adapt the deployment to the immediate needs and study startup timelines of your organization, but that also has the proven wherewithal to ensure deployments that have met the needs of fast paced COVID studies.
However, even with the overall management of the trial process covered by a CTMS, the permanent impact of the pandemic has been a dramatic shift to virtual and hybrid trials. This requires additional specialized eClinical tools for source data capture, regulatory document management, consenting, and more. Luckily, complimentary eClinical systems are much simpler and faster to deploy and make operational, especially when coming from the same vendor as your CTMS.
Electronic Regulatory Document Management
If you want to maintain regulatory compliance in a virtual or hybrid trial workflow, an eRegulatory system is critical to ensuring efficient review and approval processes across distributed organizations, multiple sites, or multiple studies. A comprehensive eRegulatory solution captures and manages 1572s, study policies, staff training and credentials, consents, protocols, amendments, and more. It also includes change tracking of document details, with site driven quality checks and audit trails that ensure only appropriately signed documents are shared for monitoring. Remote monitors can securely login to easy to use study optimized dashboards, check status, comment to site via chat, and attach queries to documents. Secure remote access and document management from any location, automated reminders, and compliant eSignatures also help speed up the review and approval process.
With busy people, time for training and practice are the biggest factor delaying deployment. If staff is allocated time for training with few gaps, after a few days of discovery sessions and study/play time, configuration for your specific workflow can occur soon after. In fact, eRegulatory solutions such as CCeReg have been deployed in less than 2 weeks with the right customer schedule availability. Sponsors will also benefit from the secure access and faster process of eReg, potentially covering some costs if negotiated and justified up front.
eSource Trial Data Collection
If there is any tool that is indispensable at this time, it is an eSource system. Early eSource technology was just simple “electronic data capture”. Modern systems such as CCeSource not only capture source data more efficiently than ever, they enable remote workflows, instantly share visit completion data to a sister CTMS while eliminating the cost of paper, and automate the process of keeping visit completion, compliant eSignatures, and secure remote monitoring on track. With the Bio-Optronics team offering to build the first studies, including the edit checks and skip logic of the system, you could be up and running in 4 to 6 weeks even with full time for discovery and in-depth training. There is an even higher chance that a sponsor will help cover the costs for CCeSource given its remote monitoring capabilities, so it is worth the time to explore how to get a CCeSource up and running right away. In fact, if you sign before the end of this year, you will only need to start the flexible payment schedules a few months into the new year.
eConsent System for Trial Sites
Complimentary to both eReg and eSource solutions is the more efficient eConsent approach to consenting, which secures a more consistent and compliant process with the elimination of paper, in addition to allowing for in-person or remote consenting with parallel HIPAA compliant CCVideo enhancing the quality of the interaction. The easy to use CCeConsent platform provides more engaging multi-media content that ensures understanding and increases retention. It also provides CFR 21 Part 11 compliant remote eSignatures from any device a signer may be using (true BYOD). Basic training and deployment of CCeConsent is so easy, it can usually be done in couple weeks. Bio-Optronics even provides training to help you setup the first few consent flows to submit to an IRB. There are really no barriers to making eConsent an essential part of your workflow right away.
Be Ready Now
The industry consensus is overwhelming! Enabling decentralized trials using technologies that also increase efficiency and lower costs at the same time can help reduce the uncertainty of today. The Bio-Optronics team has been helping those willing to take the risk during these uncertain times, though only those that have taken the plunge have been able to reap the benefits. The choice is yours. Try to remain operational with what you have; or bite the bullet and commit now to what you need to reduce uncertainty and be ready for anything early in the upcoming year!