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 impact on patient safety

00:12:20 – Aggregating data for holistic review to enable more proactive trial management

00:18:29 – Need for purpose-built technology (not repurposed late-stage tools) in early phase clinical operations

00:19:31 – Measuring quality through protocol adherence, data timeliness, and meaningful data ranges

00:20:12 – Strategies for managing RBQM system costs for biotechs with limited budgets in clinical outsourcing models

Top 3 Takeaways

Patient-level Data Review: For early phase studies, adopting a patient-centric review model—rather than site-to-site comparison—enhances safety oversight and aligns with RBQM principles, marking a clinical operations best practice.
Validated Technology vs. Manual Tools: Relying on spreadsheets and email for clinical study optimization risks non-compliance and inefficiency; purpose-built, validated systems improve both operational outputs and regulatory readiness.
Adapt Technology and Pricing: Technology vendors should offer flexible pricing and purpose-designed platforms to enable smaller sponsors and biotechs to implement RBQM without prohibitive costs, supporting better CRO selection and clinical trial outsourcing outcomes.

Links & Resources

The PBC Group – Event agendas, blog, and resources from Clinical Outsourcing Group meetings
ICH E6(R3) Guidance – Latest regulatory guidance on GCP and RBQM
TRI – TRI company site and technology solutions for clinical trials

Quotes

"RBQM starts at protocol design, not at monitoring visits—critical thinking up front drives quality throughout the study lifecycle." – Duncan Hall

"Early phase is where the risks are highest, but site-by-site analytic models don’t add value; patient-level focus is needed for operational efficiency." – Duncan Hall

"Validated technology, audit trails, and access control are now mandated by GCP—Excel and email just aren’t fit for clinical study optimization anymore." – Duncan Hall

"The cost of manual, low-value checking is high and unsustainable. Technology should enable smarter reviews, not repeat the same work." – Duncan Hall

"We always work with companies to tailor pricing; the goal is to partner early and roll successful approaches into larger trials in the future." – Duncan Hall

Further content and agendas: hhttps://thepbcgroup.com

-----------

Further content and agendas: hhttps://thepbcgroup.com

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