Author Archives: rammellel

About rammellel

Records management consultant to the life sciences / pharmaceutical industry

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

Are You Drowning in Email?

Whenever I chat with business colleagues, one of the most common issues that gets raised is that of email management: we’re receiving too much and spend too much time responding. Well, I just came across an “Email Charter” and thought … 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

Posted in e-records, TMF | 1 Comment

Search FDA Warning Letters

Did you know that the FDA have recently (26th May 2011) provided an advanced search capability on their Warning Letters web pages? The advanced search page now gives you the ability to search for company name (including wildcard), date range … Continue reading

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Guidelines for GP Electronic Patient Records

The Department of Health have recently (21 March 2011) revised their good practice guidelines for GP electronic patient records. I’ve just been browsing through the document and whilst much of the content is not directly applicable to me, I was … Continue reading

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