Organising Committee

Karen Roy

Karen Roy was jointly responsible for the development of the CDISC TMF Reference Model, an industry driven initiative to standardize the content, naming and structure of Trial Master Files. She chairs the management of the Model and is currently working for CDISC supporting the transition of the Model to becoming a CDISC Standard.

Karen has also re-joined the Board of the Institute of Clinical Research, a UK-based association focussed on training and being a voice for Clinical Research, she consults for Epista, a team of experts working at the intersection of business priorities and compliance requirements and is on the Advisory Board of Pharmaseal, an eTMF and CTMS technology company. Karen was previously responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for their Clients’ TMF challenges

Sally-Ann McDowell

Dr Sally-Ann McDowell has worked in Clinical Research for almost 30 years. She has worked for large and mid size CROs in positions ranging from Data Co-ordinator, Biometrics Project Manager, Clinical Project Manager, Director of Project Management, Therapeutic Area Lead and is currently a Senior Clinical Development Strategy Director. She has global experience in many different therapeutic areas, including CNS, Neurology and Oncology. Sally-Ann has been a member of ICR for many years and was involved in the Project Management Special Interest Group and helped organise the ICR PM Forum in 2022. She is currently the Co-Chair of the ICR Board as well as being a STEM Ambassador.

Stacey Edmondson

I have 15 years’ experience in clinical development, spanning roles of increasing seniority within sponsor and CRO organisations. With a background in project management, I led phase I-IV trials globally in a variety of therapeutic areas. I am also experienced in outsourcing and vendor management and have built operational teams and oversight processes to meet growing business needs. Most recently, I have spent 5 years within decentralised clinical trials, overseeing delivery of mobile research nursing and patient concierge services. I also led business expansion and regulatory intelligence, driving new business offerings globally and ensuring all activities were compliant and conducted to the highest standards of quality. I am passionate about promoting clinical research and motivated to create a best-in-class clinical trial experience for patients and sites. I strongly believe in patient-centric approaches to clinical trials in order to offer patients a flexible trial model, providing convenience, reducing burden and enhancing their trial experience. I am enthusiastic about industry-wide collaboration, knowledge sharing and training and am looking forward to using my skills and experience to help transform ICR, bringing new offerings to our members and the wider clinical research community.

Peter Davidson

Peter Davidson holds a BSc in Biochemistry and has worked in Clinical Research for 27y in Business Development including some management positions in the CRO industry. During this time, he has gained experience of Phase I-IV trials including several years working within clinical pharmacology. Peter has also gained some experience of medical device trials. More recently he became very involved with DCT and the use of data and AI in the clinical trial arena.

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