University Of Louisville Improves Regulatory Efficiency With Veeva SiteVault

By Anna Argyris

Clinical research sites, sponsors, and CROs fill the room at Veeva R&D Summit to hear how Lale Akca and Rachel Sheppard of the University of Louisville set out to transform their regulatory operations to promote efficiency and collaboration across their teams and study partners.

With 150 active trials and 60 new studies in the pipeline across 30 specialties, the Clinical Trials Unit at the University of Louisville manages a complex research environment.

A growing pipeline of clinical studies is a good thing for clinical research sites. But for sites that rely on paper-based processes, portals, and shared drives to manage studies, growth can be difficult to manage.

“We were having a lot of trouble keeping up all the new trials opening across multiple locations, all using paper processes,” said Rachel Sheppard, MBA, CCRA, CCRC, Clinical Regulatory Director at the University of Louisville. “Each team was following a different process. Information access was a real problem due to lack of standardization.”

Rachel found that each of their 20 clinical staff were spending two to three hours a week chasing investigators for signatures – amounting to 50 hours of time each week.

Sponsor provided portals weren’t helping the situation. “We had no control over their systems and they take a lot of time to learn,” said Rachel. “We got to the point where couldn’t keep track of which portal went with which study.”

The University of Louisville needed to get studies opened fast and efficiently – and remove any barriers to that goal.