As a Medidata Global Compliance and Strategy Principal, Fiona’s focus includes evaluation of GxP relevant regulatory changes coupled with the regulatory aspects of technological advancements and geo-political dynamics impacting the Life Sciences and Healthcare industries, specifically within in the clinical research domain. In this role Fiona regularly interacts with authorities on emerging patient centric technologies. Fiona is currently the Chair of the ACRO Decentralised Clinical Trials Working Party in the EU, focused on the end to end process, technology, data and regulatory frameworks for virtual clinical trials. Fiona is also a member of the EU Alliance on Artificial Intelligence. Prior to Medidata Fiona was a Director at Deloitte,

Kelly has more than 20 years’ experience in the areas of Quality, Pharmacovigilance, R&D, and Regulatory Affairs with large, global Biotech and Pharmaceutical companies. She is a Subject Matter Expert on the topics of process assessment and gap analyses, governance model design, business process review and redesign, sourcing strategy, training and Standard Operating Management (SOP) development and quality management system design. In addition to being a thought leader, Kelly is also highly skilled at leveraging resources to maximize spend and amplify impact.