Speaker Profile
Karen Roy

Karen Roy

Healthcare Technology, Pharmacy and Medicine
Buckinghamshire, England, United Kingdom

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Karen graduated as a pharmacist in South Africa and entered the life science industry working for Eli Lilly. In 1992, she moved into clinical research in the UK with Chiltern International, initially managing the Clinical Development Department across Europe. Latterly she started and globally managed a novel group, EDC Solutions. In 2007, Karen joined Phlexglobal as Global Business Development Director based at their headquarters in Amersham in the UK. As the Trial Master File Experts, Phlexglobal is a specialist provider of technology-enabled, Trial Master File (TMF & eTMF) document management solutions and support services. With Karen’s significant clinical and EDC experience, she is the driving force for Phlexglobal’s eTMF Solution, PhlexEview and is now Senior Vice President of Client Solutions. Karen helped to spearhead and co-chairs the TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of TMFs. She remains an advocate and spokesperson for the TMF Reference Model, now in version 3, recently released.