by Michael Shanler | April 5, 2016 | Comments Off on Dealing with Electronic Trial Masterphobia…
There’s an eTMF monster hiding under the bed…
Well, not really…but I did recently have a conversation with a pharma R&D CIO (btw- he pre-approved me to blog about this) who mentioned that his clinical and TMF stakeholders were afraid of the consequences of moving away from a hastily implemented, resource-intensive, SP-based solution onto a new platform. AFRAID! The picture below sums it up….
(Source: Google Images, The Monster Under the Bed https://analienparisienne.files.wordpress.com/2010/06/monsterunderbed.jpg)
Everyone in IT deals with similar nightmares from time to time. Some of the nightmares are about implementation and validation. Others are about investing in the wrong vendor. A large number are worried about eTMF cost escalation as sites expand. That being said, everyone eventually needs to rip out an old system and put in a new one. In the case of many eTMF environments, folks need to first be comfortable moving beyond the “compliance-only” strategy. Some need to first be comfortable moving from paper to electronic. At any rate, moving off of existing systems can be nerve-racking. Looking beneath the platform might reveal some unexpected and startling findings. We need to face the fear. Slay the dragon, etc…
Many eTMF systems offer serious advantages that deal with end-to-end eTMF process, quality, and insights. However, how far you extend your eTMF needs to be consistent with the business strategy, IT Model, and your organization’s TMF maturity. If you select the wrong strategy for your environment, the wrong technology, or the wrong vendor…and other nightmares will intensify and cause you to loose even more sleep. But, if you select the right approach for the right reason with the right partners? …Then catching those eTMF Z’s won’t require Ambien.
Here’s a link to the note: Electronic Trial Master File Strategy Alignment ( G00281134)
It goes into
- The main eTMF strategies – “applications” vs “platforms” vs “ECM-centric” vs “Outsourcing / Services” and the pros and cons.
- The very wide spectrum of Cloud deployment models. (I just love it when vendors simply say they have a “cloud solution”)
- eTMF org maturity– a kind of self-assessment/ litmus tool.
- eTMF “Solutions” list – All those vendors & consultancies (e.g. Veeva, CSC, Documentum, PhlexGlobal, ePharmaSolutions, Transperfect, Wingspan, etc.)
Reducing anxiety starts with strategy first. Then the technology and vendors. Then, you’ll find that the monsters under the bed really aren’t monsters at all.
Read Complimentary Relevant Research
Four Ways for CIOs to Cultivate Digital Dexterity in Leadership and the Workforce
To thrive in the digital era, enterprises need digital dexterity as an organizationwide competency. CIOs can boost their value by developing...
View Relevant Webinars
Comments or opinions expressed on this blog are those of the individual contributors only, and do not necessarily represent the views of Gartner, Inc. or its management. Readers may copy and redistribute blog postings on other blogs, or otherwise for private, non-commercial or journalistic purposes, with attribution to Gartner. This content may not be used for any other purposes in any other formats or media. The content on this blog is provided on an "as-is" basis. Gartner shall not be liable for any damages whatsoever arising out of the content or use of this blog.