Fiona Maini BSc. MSc.

Principal Global Compliance and Strategy Medidata Solutions a Dassault Systèmes Company

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 and industry bodies on modern tech strategies such as emerging patient centric and clinical platform technologies.

Fiona is currently the Chair of the ACRO Decentralised Clinical Trials Working Party in the EU, focused on the development of the end to end process framework, quality by design guidance and risk assessment criteria for decentralised clinical trials, particularly useful guidance during this COVID-19 pandemic when organisations are switching to more remote strategies for running clinical trials. Fiona is also a member of the EU Alliance on Artificial Intelligence.

Prior to Medidata Fiona was a Director at Deloitte, where she led the Deloitte Global Centre for Regulatory Excellence for Life Sciences and provided governance and oversight of Deloitte services to the European Medicines Agency.

Prior to Deloitte Fiona also has 4 years’ experience as a research chemist working within R&D.

Fiona has an MSc in Chemistry, a BSc in Chemistry, Management Science with French, which included an Erasmus year at the University of Liège, Belgium.

Clinical Trial Design Agenda

Thursday, December 10th, 2020


  • How is the industry reacting to this shift in leveraging remote strategies?
  • How do we balance key factors such as patient centricity, data, regulation, compliance and cost, and should flexibility be the greatest priority?
  • What impact is this having on the regulators and how they operate?
  • Will remote trials affect data endpoints and to what extent?
  • What impact do virtual, decentralised and hybrid trials have on patients and how can we reduce potential burdens?
  • How is this influencing patient engagement strategies?