Category Archives: TMF

eTMF Vendors – Who Has the Largest Market Share?

This is a question just sent through to us….. which vendor has the largest market share of the eTMF solution vendors? I guess the answer will depend on whether we’re talking about most client licenses/seats or highest volume of sales and whether … Continue reading

Posted in e-records, TMF | 2 Comments

Documentation Risk Adaptations in Clinical Trials

A paper has recently been published under the joint auspices of the UK Department of Health (DH), the Medicines and Healthcare products Regulatory Agency (MHRA) and Medical Research Council (MRC) describing risk-adapted approaches to the management of clinical trials of … Continue reading

Posted in Compliance, Records management practice, Regulations, TMF | Leave a comment

Why Good Records Management Is Key

Authors: Eldin Rammell & Karen Redding (Phlexglobal Ltd) The past year has seen significant consolidation of mid-size CROs, with many of them being bought or put up for sale. In particular, the top six or seven CROs seem to be … Continue reading

Posted in Records management practice, Technology, TMF | 1 Comment

eTMFs from your Contract Research Organization (CRO)

I was recently asked what happens at the end of a clinical project when the CRO managing the study wants to hand over an electronic trial master file (eTMF). The sponsor may not have an existing eTMF to take the … Continue reading

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What solution for my eTMF?

We often get asked what technology solutions are available for the management of electronic trial master file content. There are countless companies that provide bespoke IT development services to build your own system, often based around Sharepoint or Documentum. However, … Continue reading

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Financial Disclosure to FDA – New Draft Guidance Available

Yesterday, 24 May 2011, the Food & Drug Administration (FDA) released for public review and comment a draft revision of the guidance for financial disclosure by clinical investigators. This will replace the last guidance issued back in 2001. The revised … Continue reading

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Use of the DIA TMF Reference Model by CROs

Here’s a quick plug for a great article about the use of the DIA TMF Reference Model by CROs. The Reference Model is a standardized model for the structure and content of the essential documents that comprise the trial master … Continue reading

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