eTMF: Delivering Unexpected Benefits

By Sharon Ames, Enterprise Program Director, NextDocs

Maybe it’s just me. Maybe it’s just because I’m so involved in helping firms involved in clinical research. But as I stand at the counter at the pharmacy and look all the containers of medications lining the shelves, I can’t help but think, “Wow, most of these drugs were brought to market without an electronic Trial Master File (eTMF).  Most those drugs came to market on a trial made of paper.”

This should not astonish me, but it never fails to do so. Why? Because my experience with companies using an eTMF has exposed how many challenges and pitfalls lie in the path of a paper-based approach. It’s so easy for things to go awry in a paper-based world. It’s also so confining – in ways that are sometimes hard to understand because they’re so familiar.