New ways of doing business in a post-COVID world
By Kathryn E. Vinson, MS, CCRC
Clinical research can be thought of like the proverbial well-oiled machine. We have our processes and procedures that are tried and true. We are prepared for a multitude of contingencies – adverse events, non-compliance, and regulatory issues to name just a few. But then came the novel coronavirus and a wrench got thrown into that well-oiled machine. Suddenly clinics were closed to all but non-emergency visits, supply chains were interrupted, and we were forced to change gears with little notice.
In a business that largely depends on personal contact, COVID has forced research professionals to think outside the box in terms of collecting data from trial participants. While some data points require in-person visits, such as labs and radiology, many data points can be collected from the participant. Electronic informed consent documents, patient diaries and even certain vital signs can be obtained digitally, either via scanned documents or video conferencing.
One thing that COVID has taught us is of our amazing ability to collaborate with co-workers from afar. Online meeting platforms such as Zoom, Skype, and Microsoft Teams*, have brought conference rooms around the world together, and in many cases allowed us to work remotely. These programs have given us the ability to conduct site initiation visits as well as monitoring visits remotely.
As discussed in “A Not So Risky Business,” DZS Clinical Services brings you a team that is experienced in not only centralized remote monitoring and risk-based monitoring practices, but also in the development of clinical protocols with such monitoring plans in mind.
Now, more than ever, it is vital that our site selection processes direct us to those sites with proven track records of accrual and performance. With limited abilities for onsite visits, those sites with established histories of successful trial execution or experience with a given device, give sponsors the confidence to know that their trials will be carried out according to plan.
Another area of expertise that is becoming vital is remote monitoring experience as discussed above. While this practice was becoming more mainstream prior to COVID-19, not all sites/studies have utilized these capabilities. Sites that can accommodate such monitoring plans with ease have a leg up on their competition.
Bringing it all together
Here at DZS Clinical Services, our global network of successful research sites, as well as our team of seasoned research professionals are uniquely prepared to assist you with any and all aspects of your clinical trial in a post-COVID world. Our ability to evaluate a site’s ability to participate in trials utilizing virtual site selection and initiation visits, as well as remote monitoring plans helps to ensure that your trial will be run smoothly from the start. Whether you need a site that has experience with a certain device, assistance in developing a remote monitoring plan, or advice on remote data collection, our decades of experience bring your team the knowledge that the well-oiled machine of clinical research will continue to run smoothly.
*Disclaimer: DZS Clinical Services does not endorse a specific remote meeting platform. These platforms are listed for illustrative purposes only.