Electronic Trial Master File (eTMF) Fact Sheet

The estimated cost of bringing a new drug to market can range from hundreds of millions to billions of dollars, with approximately 90% of the cost devoted to large, multi-center Phase III trials. These staggering costs are driving the industry to seek ways to reduce the costs of drug development through changes in protocol design, trial management, and innovations in technology.

The Trial Master File (TMF), the backbone of every clinical trial, supports the quality, integrity, and validity of the data collected in the trial. With TMF contributors and consumers now positioned around the globe, there is an obvious need for companies to move towards eTMF technology. Adoption of an eTMF solution can provide transparency to all stakeholders, reduce direct and indirect costs, improve the quality of the files, and position an organization for success with other innovations such as targeted or remote monitoring.