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The TMF Reference Model Version 3.0 and the ISF – By Betsy Fallen, Consultant, eInvestigator Site File Project

July 27, 2015

By now you’ve heard the recent announcement released by the TMF Reference Model (TMF RM) working group ( regarding the availability of the latest version of its best practice model. It’s been a couple years since the last update and, …
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Spread the word! By Betsy Fallen

May 18, 2015

This week, I am very excited to return to the MAGI Conference East ( to speak on ”Risk-Based &Centralized Site Monitoring: Implementation”. I’ll be presenting the model that Phlexglobal refers to as Document Risk-Based Monitoring.  The audience for the MAGI …
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The Season of Seminars and Conferences is Upon Us! Written by Betsy Fallen, Consultant, eInvestigator Site File Project

April 29, 2015

Many industry colleagues will participate in the Phlexglobal TMF Innovation Seminar tomorrow in Cambridge, MA, USA. I’m looking forward to speaking along with Vinita Leslie, Trial Master File Process Owner, Biogen Idec & Karen Roy, Chief Business Development Officer, Phlexglobal.  …
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The Next Episode: Extending the eTMF: Electronic Investigator Site File – written by Betsy Fallen, Consultant, eInvestigator Site File Project

December 18, 2014

Progress! The advancement of the eISF and its capabilities continues! As I see it, there are three significant opportunities in this platform. One key value is enhancing inspection readiness. If the full complement of expected Site Essential Documents is identified …
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Extending the eTMF: Electronic Investigator Site File – written by Betsy Fallen, Consultant, eInvestigator Site File Project

December 2, 2014

The Healthcare arena is quickly becoming digitized with the adoption of Electronic Health Records and the subsequent Electronic Data Capture. The submission of marketing applications to regulatory authorities is on plan to be entirely digitized.  The digital management of Essential …
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Spotlight on the TMF Reference Model!

September 2, 2014

Industry accepted reference model for Trial Master File content Version 3.0 development starting imminently – get involved! Other initiatives – Usability, Metrics, Interoperability Quality The Trial Master File Reference Model (TMF RM), a supported initiative of the Drug Information Association’s …
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2nd UK PhlexEview and eTMF User Group – written by Gillian Gittens, Head of Marketing

April 16, 2014

The 2nd UK PhlexEview and eTMF User Group was opened by Managing Director Stella Donoghue, who welcomed our client attendees and Phlexglobal staff, and provided an update on Phlexglobal and the TMF landscape. She also expressed the company’s goals to …
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Phlexglobal being Disruptive! – written by Gillian Gittens, Business Development & Marketing Manager

March 18, 2014

John Lazenby, Technical Development Director; Carl Rhone, our newest Business Development Manager and myself, Gillian Gittens, attended and exhibited the inaugural Disruptive Innovation in Clinical Trials Conference in London last week. This conference was marketed with headlines such as “Discover …
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What to Expect When the MHRA are Inspecting…….by Liz Hooper, Archiving & Records Management Consultant, Phlexglobal

November 14, 2013

I was lucky enough to be invited to join the first MHRA Stakeholders Engagement Meeting; a meeting replacing the previous separate GCP, GLP, GPvP and GMP meetings, as some of the information the MHRA want to pass onto industry representatives …
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Project Management Academy Update

October 2, 2013

Written by David Saunders The Phlexglobal Project Management Academy (PMA) was launched in February 2013 and I was fortunate enough to be included in the first intake of students. We are now around six months into the program and I …
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