On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.  We were able to achieve such success when we completed 12 virtual, customized, site feasibility assessments of facilities located throughout the U.S. for a respiratory study. Given the current resurgence of COVID-19, the safety of site staff and our study team was paramount. To minimize the risk to the sites and our CRAs, we elected to conduct the site qualification visits virtually, which required creating hybrid approaches to utilizing our virtual platforms.

Pre-planning

Advance preparations were critical when it came to planning our virtual Site Qualification Visits (SQV). Based on our prior decentralized trial experience, we were able to quickly assess the data we needed from our virtual visits to make the most confident decisions selecting our sites.  After reviewing each site’s feasibility questionnaire, we emailed the site asking them to provide their scheduling availability over the next few weeks. In addition, we realized the value of having all the stakeholders together in the meeting and requested that the following key site personnel attend the visit, which we expected to take 3-4 hours.

• Principal Investigator (required, approximately 1 hour)
• Research Coordinator(s) (required, entire call)
• Pharmacist (required, 30 minutes)
• Sub-Investigators (optional)
• Regulatory staff member (optional)
• Contracts/budgets Manager (optional)

We were able to manage expectations by noting the amount of time each person would be needed on the call and we offered flexible scheduling options to accommodate staff that were unavailable on the primary visit date/time.

Virtual Platform Solutions

During the remote SQVs, we wanted to tour the facilities and equipment, including the pharmacy, and made sure that the sites had the ability to conduct a video tour of the noted facilities during the call. Our CRA confirmed access to alternative video-conference technology with the site that we could use as “back-up” if platforms such as WebEx or FaceTime didn’t work or weren’t available. Some platforms may compromise organizational security and confirming which technologies are available and/or accessible per institutional IT policies are key to ensuring a successful virtual visit.

The assigned CRA set up a WebEx session with web camera capabilities as one method of conducting the virtual tour. One of the sites had pre-recorded a video tour of their facilities and had the link accessible to preview via YouTube, which the CRA was able to view as an additional resource. The live tour was conducted during the SQV to confirm that all study specific requirements were met. Clearly, sites are adjusting to this COVID-world and are proactively finding ways to address the standard request.

The main presentations were conducted via WebEx and then the Site Coordinator/CRA had the option to switch to FaceTime for the tour, which proved to be a more convenient option using a smaller device to conduct the tour. Of note, there are other virtual platforms, such as WebEx, that have robust phone applications, which may be preferable to carrying a laptop around a facility. The transition from WebEx to FaceTime took some extra time, but once that happened, the CRA communicated this change to site personnel for subsequent visits, so that they were prepared and timelines weren’t impacted.

Of the 12 SQVs we completed, we selected 8 viable sites and 2 alternative sites based upon the nuanced criteria we collected during the tour. We leveraged our past experience to adapt our preparations for the SQVs. The virtual platform strategies we employed significantly shortened the SQV time period within the study start up timelines, reduced travel costs, created user friendly assessment options and flexibility, and above all, protected all staff from any COVID-related risks.

Hybrid virtual applications in clinical trial processes can positively impact the course and integrity of the trial. To realize the advantages and benefits of a well-executed virtual clinical development program, it’s critical to partner with a CRO with experience planning and implementing successful decentralized solutions.

Nancy Woody, MA, PMP, Senior Project Manager, has over 8 years of CRO project management experience supporting and leading Phase 1 through 4 global and regional trials. She has provided leadership to cross-functional clinical research projects and teams, virtually and co-located, in a wide variety of indications including Rare Disease (cystic fibrosis), CNS (Alzheimer’s, Multiple Sclerosis, spine pain, women’s pain, etc.), endocrinology (Diabetes) and oncology (Multiple Myeloma). She has a background in intercultural training and conflict resolution, which has helped to inform her work in risk management and mitigation on complex trials and within diverse teams. Ms. Woody is a certified Project Management Professional and received her Master’s degree in Intercultural Relations from Lesley University and a B.A. in Communication Studies from the University of North Carolina at Chapel Hill.

Fran Sawyer, Clinical Team Lead, has over 13 years of industry experience including serving as a lead on a Vaccine, Cardiovascular, Pain, COPD, and Osteoarthritis trials. Her other study indications include high risk vascular disease and lowering LDL, atrial fibrillation, asthma, graft versus host, breast cancer, and sickle cell disease. She joined Rho in 2014 and is a seasoned leader with training and mentoring experience. Ms. Sawyer has a strong understanding of clinical trial management and delivery requirements that has allowed her teams to successfully meet data timeline deliverables for various multi-center trials. She is also adept in all aspects of GCPs, regulatory requirements, and site management. Ms. Sawyer earned her BS from North Carolina State University in Raleigh.