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ICR Ethics & GCP Forum

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 and sponsored by HRA. It attracted nearly three hundred and fifty delegates from a variety of disciplines and institutions; a mix of pharma, biotech and heath service. Our speakers were representatives from the MHRA and from the Health Research Authority and it was enlightening to hear of action rather than intent. Things have changed and are changing. In particular, Janet Wisely and Janet Messer, from the HRA, gave insight to their growing agenda of dealing with National Information Governance, The Over-volunteering Prevention Scheme, Collaboration Groups (training for researchers!), and, of course, everything perfect about IRAS 2013. It was a genuinely optimistic session. Martyn Ward, from the MHRA CTU, gave an insightful deliberation on the status of the proposed EU Clinical Trials Regulation. In short, the current burden of a divergent approach, any proportion for the academic, and lack of global focus, will be compensated by upcoming tacit approvals, two-stage risk adaptive models for monitoring, and transparency at the end of trials. Time was limited for discussion and the marginalia topics such as ‘linguistic poverty in consent’ by Hugh Davies, Research Ethics Advisor to the Health Research Authority (that’s easy for you to say), were given less attention that their subjects deserved. With the biggest research reshuffle in the NHS’s recent history happening over the next month, this was all critical information to giving us confidence that when the balls are thrown up in the air, someone is ready to catch them securely on their decent. It’s not just the people on the inside, at the coalface, who hold crossed fingers behind their backs. The World is watching.

To discuss this in further detail please contact Dr Gareth Hayes:


"There are CROs that have the capability to do it, some do have the electronic systems. But there isn’t anybody I know who provides as good a solution as Phlexglobal."
Senior Director in Clinical Operations, top 20 global pharma
"Phlexglobal has experience in handling eTMF documents and has this as its core competency. It makes sense to outsource to them."
Associate Director of MRP Management, US pharma

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