Case Study: a major biotechnology company achieves faster database lock and improved safety tracking with Datatrak Fountayn EDC

a major biotechnology company cuts database lock time from 8 weeks to 4 weeks with Datatrak

A major biotechnology company faced challenges with lengthy, paper-based pivotal clinical trials, including slow data availability, difficulty tracking safety, and a prolonged database lock process. To accelerate timelines and cut costs, they partnered with vendor Datatrak to implement an electronic data capture (EDC) solution, specifically migrating two existing long-term studies to the Fountayn Platform.

Datatrak implemented a structured migration process, mapping existing data into the EDC application and verifying data integrity. The solution provided daily data refreshes, proactive safety monitoring, and mandatory field prompts. The results were immediate: elimination of omission queries, proactive handling of serious adverse events, and a significantly reduced time to database lock—cut from eight weeks to just four. The sponsor gained real-time visibility into safety data and improved operational efficiency.

Major Biotechnology Company