Countdown to Compliance: Navigating New UK Requirements

As Disclosure Regulations Research Manager at Citeline, Benedict works on the content development and expansion of TrialScope Intelligence, ensuring that sponsors have access to reliable, up-to-date regulatory insights to inform actionable regulatory intelligence. With a strong foundation in science, regulation, and project management, Benedict has worked across the biotech, life sciences, and medical technology sectors, helping organizations navigate regulatory requirements.

Amy is a publishing and research transparency specialist, currently serving as Programme Manager at BMC for the UK’s Clinical Study Registry, ISRCTN.

In this role, she leads the publication of the registry, which ensures that studies and their results are made publicly available, supporting an unbiased and complete evidence base. Amy oversees the editorial team handling clinical study records and results, while working closely with ISRCTN’s board of directors to further develop and futureproof the registry. Her role as Programme Manager also forms part of the WHO’s International Clinical Trials Registry Platform network; fostering global collaboration with other clinical study registry managers, policymakers and researchers. Amy sits within the Advisory Group for Be Part of Research as a Stakeholder Partner, and contributes to other initiatives such as Data Ethics Club, BMC’s brand steering committee, and the Greener Trials Network. Some of these opportunities have led to advisory roles on several ongoing and upcoming research projects on transparency and open research practices.

Previous experience in the publishing industry has included launching and leading F1000’s Life & Medical Sciences commissioning team, and overseeing journal portfolios at BMC and Wiley. Before entering publishing, Amy gained a BSc in Zoology from the University of Bristol.

Kate graduated from Oxford University with a BA in biochemistry and a DPhil in microbial pathogenesis, then completed 2 years’ post-doctoral research at Imperial College London. She left academia to join a growing early-phase CRO in London, where she worked for the next 23 years in a variety of roles, and ultimately, as their Director of Scientific Services, became responsible for regulatory affairs, project management, medical writing, quality assurance, laboratory services, data management, statistics, and computer system validation. In 2021, she joined Quotient Sciences, where she is currently VP, Regulatory Affairs.

Kate has written numerous publications, including the chapter on Good Clinical Practice in the Textbook of Pharmaceutical Medicine.

During 2021, Kate worked with her colleague, Simon Lee, the MHRA, HRA and ISRCTN to devise the UK deferral process for registration of phase I trials, and drafted the ISRCTN guidance on the process. Kate regularly represents the Clinical and Contract Research Association and the interests of the wider phase I community in meetings with the UK authorities.

Clive Collett is the Head of Policy and Engagement within the Health Research Authority’s Policy and Partnerships Directorate. He has over 25 years of experience of research regulation and research ethics committees within the NHS. He has been closely involved in the update to the UK’s clinical trials regulations, including the introduction of new research transparency requirements.