To lower costs and expedite the clinical trial approval process, government agencies such as the US Food and Drug Administration
(FDA) and the European Medicines Agency (EMA) have implemented electronic document management initiatives that promote the automation and digitization of Trial Master Files (TMFs). For instance, through CFR 21 Part 11, the FDA encourages the use of electronic records and content as well as digital signatures in clinical trials. As a result, US organizations involved in US clinical trials can move from a paper-based TMF to an electronic TMF (eTMF) and still be in compliance with FDA regulatory policies. In response to these initiatives, ABT Medical brings a comprehensive suite of Trial Master File solutions to the clinical studies marketplace through its eTMF platform. Each of the eTMF suite’s seven application/service/solution components relieves one of the uppermost concerns of clinical studies operations: audit readiness at a moment’s notice. This real-time solution contributes to compliance readiness and makes clinical studies more efficient, more cost-effective, and less likely to be stalled by workflow delays. With eTMF, life science sponsors and Pharmas get their products to market more quickly and ultimately into the hands of patients in need.