Trial Master Files (TMFs) are meant to tell the story of a clinical trial for regulatory inspectors; they are the go-to place for all relevant details on how a trial was designed and conducted.
Electronic versions of TMFs (eTMFs) are increasingly common, although there are still a number of companies using paper-based systems or some hybrid approach. In this case, however, “digital” doesn’t always equate to “better.” Just because a TMF is electronic doesn’t mean that it is automatically intuitive, interoperable, configurable, and well designed. Many eTMFs are, as Janet Woodcock, Director of the US FDA’s Center for Drug Evaluation and Research (CDER), described, little more than “electronic paper.”1 In other words, they are mere repositories that lack all the functionality and benefits one can expect from today’s advanced technology. Indeed, if it is not done properly, digitizing a TMF can actually make matters worse.
The next generation of eTMF systems, however, are coming into their own. They use Artificial Intelligence and Natural Language Processing (NPL) to improve efficiency, preserve one version of the truth, and maintain audit readiness.
The following paper covers the current state of eTMF technology and the future level of functionality that users can now expect.