Case Study: Ludwig Institute for Cancer Research achieves automated end-to-end pharmacovigilance and faster SAE reporting with Medidata Solutions

Ludwig Institute for Cancer Research Turns to Medidata and EXTEDO for End-to-End Pharmacovigilance Solution

The Ludwig Institute for Cancer Research, a nonprofit running international oncology trials, faced inefficiencies and safety risks from a paper-based serious adverse event (SAE) reporting process. Manual data entry and reconciliation across clinical and safety databases slowed workflows and became unsustainable as studies grew worldwide.

To address this, Ludwig implemented an end-to-end pharmacovigilance solution integrating Medidata Rave EDC and Rave Safety Gateway with EXTEDO’s PcVmanager, using E2B/AS2 standards for a fully electronic SAE workflow and regulatory submissions. The integration created a single source of truth with in‑EDC medical coding and query resolution, eliminating duplicate entry, speeding site onboarding, reducing reconciliation time and queries, and delivering significant time and resource savings while improving safety oversight.

Ludwig Institute for Cancer Research