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The Clinical Sites and the Regulators have Spoken!

October 16th, 2015.
I am very excited to share that today is the day that the Survey of Clinical Site Staff to Assess Efficiencies is being closed! The response has been terrific! There have been over 115 responses and there are surprises! Some responses I expected to see were not at all what the clinical site personnel had to say. Stay tuned…

It was great to meet up with TMF experts from many organizations this week in London at the Exl Pharma EU TMF Summit. Andy Fisher, MHRA Inspector, shared many insights with the attendees, both in his prepared remarks and when questions came up. One of his current areas of interest? The eISF! Digitizing the investigator site documents, electronic signatures, managing system ownership and control and eArchival were all discussed as part of the next chapter of eTMF. This regulator hasn’t inspected one yet but he’s looking forward to it! The PhlexEisf system is ready for sharing and current clients as well prospective ones are calling for demos. If you haven’t gotten the latest information on this exciting opportunity, please send your inquiry to


"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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