The Future of Risk Based Quality Management for Early Phase Studies with Duncan Hall

Discover how risk-based quality management transforms early phase clinical operations, offers solutions for clinical outsourcing challenges, and enables a more patient-centered approach—so you can optimize your next trial’s quality and efficiency.

Speaker Duncan Hall CEO, TRI Experienced leader in clinical operations and technology innovation for clinical trials LinkedIn

Episode Overview Recorded live at COG UK, this episode features Duncan Hall, CEO of TRI, leading a focused session on risk-based quality management (RBQM) for early phase clinical trials. Presented as part of The COG Review: Building Better Clinical Studies by The PBC Group, this discussion is tailored for professionals responsible for clinical trial outsourcing, CRO selection, and operational excellence in global clinical studies.

The session tackles how RBQM, when applied from protocol design through central monitoring, can close critical gaps in early phase study oversight. Duncan Hall breaks down why traditional site-by-site analytics don’t fit single-center or low-volume studies—and outlines the need for patient-level data review as an operational best practice. He reveals how technology-enabled workflows, validated systems, and centralized reviews help reduce manual review inefficiency without sacrificing compliance or data integrity.

Key topics include RBQM’s regulatory context, practical mechanisms for improving patient safety and data quality, how clinical outsourcing models impact early phase trials, and the considerations for selecting technology solutions that fit the realities of small-scale biotechs. This episode is essential listening for anyone looking to optimize clinical operations and make more informed decisions on CRO selection and clinical trial outsourcing.

Key Moments 00:02:27 – Shifting from routine monitoring to critical, risk-based thinking in protocol design

00:03:33 – Why early phase trials carry more operational risk—and how RBQM addresses it

00:06:05 – Limitations of site-based analytics in early phase studies and implications for clinical outsourcing partners

00:07:14 – Patient-level review as a clinical operations best practice for small or single-center trials

00:08:07 – Compliance challenges posed by manual tools (Excel, email) in clinical study optimization

00:10:24 – Designing technology that prioritizes patient review, streamlines workflow, and reduces repeat effort

00:11:19 – Risks of missed data signals due to inefficient manual review and