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.
The labor intensive process was burdened by extensive manual data entry and required numerous quality checks to ensure the accuracy. Uncontrolled review and approval processes would often linger for months waiting for comments, approvals and final signatures. The resulting process required 180 days (calendar time) to submit a study registration and almost a year (300-360 days) to submit clinical trial results.
The sponsor team enlisted TrialScope to help them transition to a more systematic approach to compliance. The sponsor and TrialScope teams collaborated on the implementation of the PharmaCM solution to help reduce data entry and add appropriate controls to their review and approval processes. Users entered data directly into PharmaCM, removing the need for data entry templates. Review and approval workflows were implemented in PharmaCM with corresponding alerts and notifications tied to any deadlines that were in jeopardy. Escalation workflows were also used to “raise the bar” in meeting compliance deadlines.
The sponsor recognized huge efficiency gains as they centralized all of their disclosure data and processes on the PharmaCM platform.
1 Assumes one initial study registration, two updates for protocol amendments and one requested update, one initial study results submission and one requested update to results.