Fran Ross is an R&D Consultant at CGI Life Sciences. Focused on operational efficiency and quality risk management, she has 30 years industry/academic experience, including compliance, TMF, trial operations, CTMS, QMS, risk and records management. Fran is active in industry groups including Women in Bio, and is on the Steering Committee of the TMF Reference Model. Fran is resolutely focused on robust compliance without process complexity, and using the best-fit solution for trial speed and efficiency. Ask Fran about ICH E6 R2 and relishing risk.