The COVID-19 pandemic has underscored the need to adopt new approaches to manage and administer clinical trials that are less susceptible to known and unknown disruptors.

Clinical research sponsors are now requesting information about the Office of Research Affairs’ abilities to remotely monitor clinical trials at the University of Florida College of Medicine – Jacksonville. These include updated strategies for recruitment, enhanced safety measures for patients and flexibility in the processing of regulatory or contractual amendments and modifications. As such, it has become evident that the office must evolve its regulatory and implementation processes to include an expanded ability for remote monitoring and virtual access to documentation and data, as well as enhanced environments that allow for proper social distancing for patients and sponsors.

CLINICAL RESEARCH OFFICE

Motivated by the need for change, the Office of Research Affairs has established the Clinical Research Office, or CRO, which features a hybrid of virtual and traditional services. The CRO is built on a strategy designed to address challenges associated with pandemics and other catastrophic events. It will offer technology-driven operational platforms for regulatory processes, easy access to data and study documentation for remote monitoring, virtual patient engagement platforms and an electronic clinical trial management system integrated into our enterprise’s electronic health record.

As a key component of this more robust environment, the Office of Research Affairs has initiated a new partnership with Veeva Systems, a San Francisco-based company that provides operational solutions to academic medical centers and clinical research sites. SiteVault will be Veeva’s first product implemented at the office. This secure cloud platform is a full eRegulatory system that will reduce administrative burdens, provide efficient administrative workflows, enhance remote monitoring capabilities and deliver customized dashboard and reporting capacities.

The office has plans to become an early adopter of MyVeeva, a multichannel patient portal that helps clinical research sites conduct virtual patient visits, enabling patient-centric and paperless clinical trials. MyVeeva integrates seamlessly with SiteVault and will help increase efficiency and provide a more personalized experience for patients who enroll in research studies.

The office is strengthening the CRO’s infrastructure by hiring additional clinical research study personnel, including research coordinators, nurses and assistants. Services provided will include start-up activities, execution of studies, data capture and entry into Redcap or sponsor-dedicated databases.  The CRO has enhanced the office’s collection of information and resources, such as SOPS, budget templates, protocol development and institutional review board assistance.

Visit this link to find the updated resources and access to the Office of Research Affairs portal.