By Cristina Guerra Laurie, Country Manager, TransPerfect
Last year, we had the opportunity to spend time with many life sciences leaders at TMF Summits in London and Amsterdam and OCT Barcelona. Cristina Laurie, Country Manager, Spain, also had the opportunity to play the role of juror in a panel, titled Vendor Spotlight – Welcome to the Dragon’s Lair!, that challenged groups of attendees to identify the perfect eTMF.
Unsurprisingly, a large percentage of discussions revolved around what the future of TMF would look like. Most, if not all, of the attendees agreed on the importance of the use of an electronic content management system and striving for a paperless environment. An inspector at one of the conferences mentioned that he didn’t understand why some sponsors would continue to use paper on top of an electronic format. It is important to observe the expectations of inspectors. It is clear that this one, in particular, would raise an eyebrow at a team that is maintaining paper and electronic documentation simultaneously. Since keeping paper documents is no longer a regulatory requirement, it is becoming increasingly antiquated. Inspections are slower when documents have to be copied and sent to inspectors. Maintaining digital documentation in a central system is much faster and much friendlier to the inspection process. Additionally, maintaining both paper and electronic records only introduces extra costs: