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The Inspectors Just Left….What Happens Now? A Post Inspection Toolkit.

May 24, 2017

By Chris Seifarth, Director, Client Solutions. Managing inspections is one of the most challenging requirements across the life science industry today. Many companies struggle with developing internal capabilities and infrastructure for proactively managing inspections and the remediation of observations. Contributing …
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EMA New TMF Guideline

April 26, 2017

A new TMF guideline on GCP compliance in relation to TMFs was recently published by the European Medicines Agency (EMA). The guideline incorporates previous guidance in the EMA draft reflection paper on TMFs and includes guidance based on industry experience, …
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CEO Rick Riegel Nominated for PACT Enterprise Award Healthcare CEO of the Year

March 28, 2017

Phlexglobal is proud to announce our CEO Rick Riegel has been nominated for the 2017 PACT Enterprise Award Healthcare CEO of the Year. The 24th annual Enterprise Awards bring all the top local entrepreneurs and leaders together in one venue …
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Fast but Not Furious!

March 8, 2017

Phlexglobal is certainly not furious to be named as one of the fastest growing privately owned pharmaceutical businesses in the UK. The Catalyst Pharma Fast 50 ranking includes companies that have had at least £5 million worth of revenues in …
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Another Successful EU User Group Conference!

February 7, 2017

Early feedback shows that this year’s PhlexEview and eTMF EU User Group Conference, held last week at London Heathrow, was a huge success! The conference kicked off with a full day eTMF Workshop run by THE industry TMF Guru’s Karen …
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Our 2016 PhlexEview and eTMF User Group Conferences Deemed a Huge Success!

March 17, 2016

The conferences, at the Hyatt at The Bellevue, Philadelphia US and the Hilton Heathrow Terminal 4 UK had high numbers of attendees from over 35 life science organizations. eTMF tutorials were held on the 1st days, by Subject Matter Experts …
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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 (http://tmfrefmodel.com) 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 (https://www.magiworld.org/) 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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Phlexglobal Project Management Academy Update

August 6, 2013

Written by Lynn Ferguson, Operations Team Lead This year, Phlexglobal has launched a new and exciting programme called the Project Management Academy (PMA). The aim of this endeavour is to build high performing Project Management staff while providing Phlexglobal employees …
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International Clinical Trials Day

May 20, 2013

By Dr Gareth Hayes, Head of Training and Personal Development, Phlexglobal. Because “It’s okay to ask”. That’s the short slogan for the wonderful team at the Nottingham group of hospitals as they go about promoting clinical research to their patient …
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ICR Ethics & GCP Forum

April 2, 2013

Written by Dr Gareth Hayes, Head of Training and Personal Development, Phlexglobal. How refreshing to see a full house at a session on GCP! Well, this was the year’s first Ethics & GCP Forum, organised by ICR, hosted by UCL …
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Proposed changes to the EU Directives

January 21, 2013

Written by Liz Hooper, Records Management and Archiving Consultant, Phlexglobal and GCP-RMA President. When the 2001 EU Directive was introduced there were high expectations of increased patient safety, improved data from a streamlined process, harmonised across all the member states …
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