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The Clinical Sites and the Regulators have Spoken!

October 16, 2015

October 16th, 2015. I am very excited to share that today is the day that the Survey of Clinical Site Staff to Assess Efficiencies is being closed! The response has been terrific! There have been over 115 responses and there …
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The Development of eISF Continues…..By Betsy Fallen

September 4, 2015

As Phlexglobal continues to develop the electronic Investigator Site File (eISF), feedback from clinical site personnel was sought as they are valuable stakeholders. A goal of the survey is to understand what the Clinical Site personnel feel are considerations in …
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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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