Contributed Commentary by Ty Quinn

November 4, 2020 | The current pandemic has necessitated a drastic shift for remote site access in clinical trials, leading to a flood of technology vendors in the market with solutions to assist sponsors and CROs. Vendors that provide Electronic Investigator Site File (eISF) and Remote Site Access technology solutions are experiencing a mass scramble of sponsors and CROs looking for solutions to support a pivot due to COVID—a pivot to remote processes that is here to stay far beyond the pandemic.  

Why would a sponsor or CRO choose to permanently adopt remote site access and monitoring technology when their business model has historically been based on onsite visits? And, furthermore, will CROs and sponsors adopt a remote site monitoring and access platform and forgo onsite visits?

The answer is a resounding “Yes.”

Many sponsors and CROs are turning to remote site access solutions not because of a temporary panic, but because they understand the significant benefits adoption a solution would bring their organizations. Below are the top five benefits for sponsors and CROs after adopting a remote site access and monitoring platform to manage their clinical trials.

1. Improve Study Start-Up Timelines by 40%

   Getting a study up and running quickly not only keeps you ahead of your competition but also has the potential to get your product to market faster.

   Sites are required to gather an enormous number of documents, like site contracts, IRB submissions, and 1572’s before they are ready to enroll patients. Managing these documents, either manually or via email, is time-consuming and very difficult to track.

   Utilizing a remote site access solution enables a site to provide its sponsors and CROs with a “portal” for real-time document exchange which significantly reduces timelines and enables documents to be tracked throughout their respective execution processes.

2. Increase Available Time to Monitor Documents for Quality

   When utilizing a remote site access solution, your Clinical Research Associates (CRAs) no longer have to rush through their document review process due to onsite visit restraints, like room reservations, site personnel allocations or travel deadlines.

   CRAs may access documents at their leisure and review without the pressures associated with onsite visits. Allowing CRAs to review documentation on their own time enables enhanced focus on document quality, which ultimately results in a significantly improved value and completeness of the Electronic Trial Master File (eTMF).

3. Lower Clinical Research Associate Turnover Rates

   One of the most valuable positions within a sponsor or CRO organization is the one that consistently experiences the highest levels of turnover. CRAs are managing increasing numbers of sites and must visit those sites with some level of frequency.

   Travel logistics often present a challenge and are directly linked to turnover rates. When the same documents and data can be accessed through a remote site access solution, the challenges of travel requirements and CRA turnover no longer exist.

   CRAs can continue to do their job of monitoring site and patient data from the comfort of their office or home and demonstrate a much higher level of job satisfaction as a result.

4. Cost savings through the utilization of alternative resources
   

   While CRAs typically serve as the “Site Ambassadors,” a remote site access solution allows other employees to manage site data and documentation.

   Easy site access allows tasks, like document management, review and approval, to be reassigned to well-trained but more junior staff within an organization. Task reassignment provides the CRA with more time to focus on the strategic elements of the site relationship while the document-related tasks can be handled by other resources.

   Reallocating resources results in headcount cost-savings and will likely yield process efficiencies over time.

5. Improve research site relationships
   
   Sponsors and CROs rely on sites to enroll, treat, and care for the patients associated with a given trial. Despite this, there are situations in which unrealistic expectations regarding Investigators, dedicated workspaces, binder access, and response times are placed on sites. Through an always on, digital connection, these expectations change. The sense of urgency due to limited time on site goes away. Documents may be viewed at the CRA’s discretion while minimizing the need for dedicated time with site staff. Additionally, the requirement for dedicated workspace is eliminated. Site staff previously committed to attending to these needs can now dedicate more time to patient care/safety, which is the best use of their time.
   
   The deployment of a remote site access solution is critical, especially with the current limitations and restrictions to site access due to COVID-19. A remote strategy will carry sponsors and CROs into the next phase of their business’ evolution.

Ty Quinn is Vice President and General Manager for Contract Research Organizations (CROs) and Sponsors at Florence, the leading eISF + Remote Site Access platform in clinical trials with more than 8,000 study sites in 27 countries connected to the platform. Ty works with industry sponsors and CROs in research to create collaborative technology solutions that advance research. He can be reached at ty.quinn@florencehc.com.