UK-based contract research organisation Phlexglobal has launched a consulting group to provide expertise on all aspects of records management in clinical trials, with a specific focus on Trial Master Files (TMFs), electronic TMFs and the migration from paper to electronic records.
The new eTMF Consulting Group is led by Jane Clarke, who joins Phlexglobal from Wyeth. Noting that electronic data capture (EDC) is now “firmly embedded in the clinical research arena”, Clarke said eTMFs are “following the same pathway, with many companies embarking on eTMF programmes”.
Unlike other platforms, though, eTMFs “are only partially about the system”, Clarke added. The people, processing and workflows involved “are equally important aspects to get right. Phlexglobal specialises in the whole package and I am excited to be joining at this critical stage”.
As well as running the new group, Clarke will be responsible for enhancing the functionality of Phlexglobal’s bespoke eTMF solution, PhlexEview, drawing on customer requirements and the company’s vision for the future of eTMFs.
During her time at Wyeth, Clarke gained significant experience in the development, integration and support of clinical research platforms such as eTMFs, EDC, clinical trial management systems, electronic patient reported outcomes and interactive voice response systems through the creation of a division dedicated to these activities, Phlexglobal noted. She also successfully implemented electronic data capture at Wyeth, with a 90% take-up in 11 months.
Phlexglobal specialises in five core areas of clinical research, including electronic document management and resourcing. It has been pioneering the use of TMFs since its inception in 1997 and for the past eight years has focused on support for, and development of, eTMFs, working with more than 100 companies in the field.