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Dealing with Electronic Trial Masterphobia…

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

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 / Servicesand 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.

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Category: analytics  clinical-development  compliance  eclinical  gartner  it  pharma  pharmaceutical  product-development  rd  regulatory  science  

Tags: clinical  cro  etmf  pharma  rd  

Michael Shanler
Research VP
5 years at Gartner

Michael Shanler covers life science R&D technologies. Read Full Bio

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