Epista Life Science announces Karen Roy joining the Clinical Team

Hørsholm, Denmark - April 22, 2024

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Epista Life Science is excited to announce the addition of Karen Roy to Epista’s Clinical Expert Team. Karen joined Epista as a consultant, providing subject matter expertise in the Clinical field with a specialisation in trial master files. With her expertise and dedication, Karen will play a vital role in driving expansion and success at Epista.  

Karen brings a wealth of experience and knowledge to Epista. Until recently, Karen was 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 was also 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 – a Model used by most pharmaceutical companies and CROs. She is furthermore working for CDISC managing the transition of the Model to becoming a CDISC Standard.

Epista’s Chief Growth Officer, Flemming Kjoeller, welcomes Karen to the growing team: “We are thrilled to have Karen on board of the Epista Team. We are confident her industry insights and excellent skills will significantly contribute to Epista’s success and goals.”

Karen has also re-joined the Board of the Institute of Clinical Research, a UK-based association focused on training and being a voice for Clinical Research. She expressed her excitement about joining Epista as well: “I am happy to join Epista and to be part of such a dynamic team. I look forward to bringing my expertise and skills to the company and to help Epista grow in the clinical field.”

For more information please contact:

Flemming Kjoeller, SVP & Chief Growth Officer – email: FLK@epista.com

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About Epista

Epista Life Science (Epista) is an IT service and consulting company with 150 employees that assists life science companies worldwide with digitalization, validation, and quality assurance. They are headquartered in Denmark and have subsidiaries in Sweden, Germany, and Switzerland. The company works at the intersection of business and compliance to anticipate the impacts that changing technology and regulatory requirements will have on the industry. By implementing technologies and pioneering methodologies, Epista helps their clients adapt while also increasing their performance. In this way, they help the industry drive the innovations that improve health care around the world.

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