Running Your Trial In Your eTMF

By Jacki Petty

In the third installation of this Trial Master File management series, industry expert Jacki Petty educates readers on the last crucial part of implementing an eTMF: people.

To get to this point in the series, your team has likely already invested some significant time and money. Perhaps you’ve even won the business case for implementing an eTMF and selected a system that’s right for you. Or maybe you’ve started writing your new SOPs and processes, with what feels like countless revisions and edits in the vain attempt to get V1.0 finalized before the eTMF goes live (spoiler alert – you’ll be writing V1.1 within a week)!

While you're probably busy defining the metrics and discussing thresholds, your team feels ready to keep a close eye on the trial’s TMF Health. All the foundations are now in place to be eTMF superstars, right? However, there is more to consider before taking the next step.