Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

Is the Clinical Database part of the Trial Master File (TMF)?

Posted on July 27, 2015

This was a question posed recently on the MHRA GCP Forum (see http://forums.mhra.gov.uk/showthread.php?1858-Database-and-TMF).  I posted a response (though it wasn’t published by the Forum Moderator) pointing out that for several reasons the clinical database should not be considered an “essential document” … Continue reading →

Posted in Compliance, e-records, Technology, TMF | 2 Comments

Vacancy: Ass. Director – TMF (Biogen Idec)

Posted on July 23, 2015

  This position is responsible for managing overall Trial Master File (TMF) operations including third party vendors and TMF systems. Act as a single-point-of-contact for all vendor inquiries and for all TMF vendor management activities (e.g. performance management, issue resolution, … Continue reading →

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Vacancy: Head of Trial Master File (INC Research)

Posted on July 2, 2015

Do you want to be a part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical … Continue reading →

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Vacancy: Head of Clinical Documentation (GSK)

Posted on June 24, 2015

Requisition ID: WD31952 Position: Full time Open date: Jun 2, 2015 9:25:42 AM Functional area: Medical and Clinical Location: Uxbridge, Middlesex Upper Providence, Pennsylvania Required degrees: Bachelors Experience required: Not Indicated Relocation: Yes APPLY NOW Basic qualifications:  Bachelors Degree Preferred qualifications:  Masters … Continue reading →

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Now is the Time for the Electronic Investigator Site File (eISF)

Posted on June 23, 2015

The latest issue of Applied Clinical Trials included an article with some interesting statistics regarding clinical trial sites (see ‘Characterizing the Real Cost of Site Regulatory Compliance’ by Kenneth A. Getz). The statistics quoted come from a survey conducted at the … Continue reading →

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EMA Cancels Revision of Reflection Paper on Trial Master Files

Posted on June 17, 2015

On 1st February 2013 the European Medicines Agency (EMA) released for public consultation a draft reflection paper on GCP compliance, including management of trial master files. After a three month consultation period which ended on 30th April 2013, industry has … Continue reading →

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Thoughts from the DIA EU Electronic Document Management Conference

Posted on December 4, 2014

[Also posted on LinkedIn Pulse] I have just attended the 15th Drug Information Association (DIA) European Electronic Document Management conference in Berlin. Here are a few thoughts and observations that came to mind as I sat through some of the … Continue reading →

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