Technology & Data Driving Europe’s ClinOps Forward

Clinical research and regulatory science professionals in Europe are currently dealing with implementing the Medical Device and In Vitro Diagnostic Regulations, the new clinical trial data transparency framework, big data, and framing how new artificial intelligence and other new tools can improve drug development. “We are very conservative as an industry, and obviously there’s always concerns about things like data protection, data integrity, and whatever we do with artificial intelligence has got to be within the bounds of data protection and data integrity guidelines,” explains Karen Roy, Senior Vice President, Client Solutions, for Phlexglobal, a provider of electronic Trial Master Files (TMFs). Ms. Roy co-chairs the DIA TMF Reference Model, an industry-driven initiative to standardize the content, naming and structure of Trial Master Files, and also serves on the program committee for DIA’s first Clinical and Regulatory Operational Excellence Forum in Europe.