Sponsor was challenged with lengthy, resource-intensive processes to support compliance in clinical trial registration and results reporting.
A global sponsor organization that develops pharmaceuticals, biologics, medical devices and over-the-counter products, sought a better approach to clinical trial registration and results disclosure requirements in the US. Using templates and spreadsheets, the sponsor team was spending approximately 20 hours to draft, finalize, approve and release one initial study registration to the US clinical trial registry (www.clinicaltrials.gov).
The Company had approximately 200 clinical trials that required registration and ongoing disclosure maintenance. The team needed an additional 20 hours per study to update, finalize, approve and release one update to a study registration. Once results were available, 80 hours of resource time was required to draft, finalize, quality check, approve and release one initial study’s results.