Case Study | March 21, 2013

EDC And Getting Ready For Migration


As the biopharmaceutical industry continues its transition to electronic data capture (EDC), the days of paper-based clinical trials are numbered. Driving this trend are factors such as lengthy study start-up time, high incidence of queries and drawn-out database lock, all linked to inefficient paper-based processes. DATATRAK ONE™ addresses these challenges by improving data quality and making them visible faster, enabling real-time safety reviews, and allowing sponsors and contract research organizations (CROs) to better assess the safety profile of a drug as it is being developed.

These well-established benefits of EDC have resulted in an estimated 60% of new clinical trial starts using the technology, with even higher rates of adoption in pivotal studies. But for companies still on the sidelines, still conducting clinical trials on paper, a short overview of DATATRAK ONE™ uEDCTM features and a case study on the paper-to-EDC migration process are presented. The case study is from a major biotechnology company, which experienced the following positive outcomes:

  • Immediate elimination of queries of omission
  • Proactive handling of serious adverse events (SAEs)
  • Significantly shorter time to database lock