A pharmaceutical client needed pharmacovigilance services for two investigational medicinal products across nine clinical trials, plus multiple compassionate use and expanded access programs. Safety cases had to be transferred from the previous vendor’s database into the client’s Veeva Vault Safety System without disrupting an active global study. Worldwide stepped in as the transition vendor, migrating legacy cases intact while keeping expedited and periodic reporting compliant across six regions. The team maintained SUSAR and DSUR submissions to Health Canada, the EMA via EudraVigilance, and the MHRA, coordinated local SUSAR filings where a local entity was required, and provided QPPV support alongside the pharmacovigilance system master file demanded by the EMA. What began as a transition study became a long-term partnership. The client moved from vendor complications into a transition to market approval in the U.S. and Europe, with Worldwide continuing to deliver clinical trial and post-market case processing and reporting.
Read the full case study to learn how Worldwide stabilized a live pharmacovigilance program, migrated legacy data without a gap in compliance, and carried it through approval and beyond.
