Current Edition

The Key to Inspection Readiness: Using Your eTMF as a Process Too

Any clinical team for a sponsor or contract research organisation (CRO) can relate to the long hours and sleepless nights leading up to the inspection of a trial master file (TMF). Paper-based processes, still prevalent in many clinical operations, result in inefficiencies and errors in exchanging and storing accurate trial documentation. Rik van Mol, Vice President of European R&D Strategy at Veeva Systems, outlines how the shift from paper to eTMFs can deliver measureable benefits to the entire clinical operations, including improved inspection readiness, centralised monitoring, and better visibility into performance.…pdf