Karen Roy was jointly responsible for the development of the CDISC TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She chairs the management of the Model and is currently working for CDISC supporting the transition of the Model to becoming a CDISC Standard.

Karen has also re-joined the Board of the Institute of Clinical Research, a UK-based association focussed on training and being a voice for Clinical Research, she consults for Epista, a team of experts working at the intersection of business priorities and compliance requirements and is on the Advisory Board of Pharmaseal, an eTMF and CTMS technology company.

Karen was previously responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for their Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and then strategy. In her role as CSO, she led all Phlexglobal partnering across the clinical space, had key strategic input into the development of their eTMF, PhlexTMF and served as a Board member.

Karen graduated as a Pharmacist in South Africa and entered the Pharmaceutical Industry working for Eli Lilly in Sales. In 1992, she moved into Clinical Research in the UK with Chiltern International, initially managing the Clinical Development Department. Latterly she started up and globally managed a novel group, EDC Solutions, before joining Phlexglobal.