The 2nd UK PhlexEview and eTMF User Group was opened by Managing Director Stella Donoghue, who welcomed our client attendees and Phlexglobal staff, and provided an update on Phlexglobal and the TMF landscape. She also expressed the company’s goals to maintain their leadership position as TMF experts, to match the roadmap to client requirements and uphold our excellent customer relationships whilst expanding our customer base; building toward continued global growth.
The sessions kicked off with a panel discussion on regulatory inspections using eTMF systems. Guest panellists were Wendy Trimboli from Eisai and Marin Thorley from Pfizer, who shared their recent inspection experiences from Inspector access and training to the differences between US/Japanese and European/MHRA Inspections. This session proved very interesting to attendees, who asked a number of questions and provided their input and observations.
Wendy then gave some insight into how Eisai works with PhlexEview and its strategic partner CROs; the key takeaway points from this presentation were to get it right with the CROS contractually; define a measurable timeline for the submission of documents to the eTMF and conduct a risk based eTMF QC.
The next session included some content from our hugely successful webinar on TMF QC, and was co-presented by Senior Resource Operations Manager Alison Hussain and Global Director of Business Development Karen Redding. This gave everyone an idea of how we QC in both paper and electronically, and interestingly a quick poll of attendees revealed no-one does enough QC of their TMFs to be comfortable!
Lunch was followed by one of the most important sessions of the day- the PhlexEview roadmap; key for all our existing clients particularly, to showcase planned features and products such as PhlexEmetrics and eQuery. This involed a lot of interest and discussion, mostly around roll out and when clients can have it!
The day concluded with presentations from Records Management Consultant Eldin Rammell and eTMF standards and Karen Redding on electronic Investigator site files; the latter again exciting great interest.
I wrapped up the meeting by reviewing and ensuring everyone’s objectives had been met and thanking all for their attendance. General feedback so far is that the day was a huge success! I think everyone left feeling better informed about the huge advantages to having a good eTMF. The main ones that came up again and again were oversight, quality, timeliness and completeness.
Unfortunately due to a Lufthansa airline strike, a number of German clients were unable to attend, so the plan is take the user group to Germany in the coming weeks; hopefully it will be as well received as this one!
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