Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

Fire at Iron Mountain Facility in Aprilia, Italy

A large fire struck Iron Mountain’s document storage warehouse and headquarters in Aprilia, Italy late on Friday 4th November 2011. According to news reports, the entire building was enveloped in flames causing substantial damage to the building and, presumably, to … Continue reading

Posted in Document Storage | 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

Questions a Sponsor Should Ask a CRO

While I was browsing through my website analytics, I came across the above question that was entered into a search engine which in turn directed somebody to the website. It got me thinking what a great question it was! So, from … Continue reading

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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

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

PDF/A Standard Now Uses PDF v1.7

The International Organisation for Standardisation has just released the second part of its standard for long-term digital preservation of documents, ISO 19005-2:2011. The first part of the standard (ISO 19005-1) was issued in 2005 and describes the file format PDF/A … Continue reading

Posted in Document Storage, e-records, Technology | 1 Comment