mindsON RBQM Experts
Working together for the community.
Stay Informed
Why We Exist
The mindsON RBQM Expert Working Group was formed in 2025. It is an autonomous, volunteer-run community of RBQM and QbD specialists from sponsors, CROs, academia, consultants, and regulators. We meet to debate real-world challenges such as Oversight of RBQM, the Dos and Don'ts of AI for RBQM, CTQ alignment, and Centralized Monitoring Oversight. We publish open-access tools that any organization or study team can use. All discussion, direction, and outputs stay member-owned and vendor-neutral.
What We Do
- The Business Case for Wellness: Why happier employees drive better results
- Strategies That Work: Practical tips for integrating wellness programs into your workplace
- Mental Health Matters:
Create a psychologically safe environment - Combat Burnout: Actionable ways to reduce stress and fatigue among your team
- The Future of Wellness: Emerging trends that companies are adopting now
- Tackle our inaugural theme: Oversight of RBQM (including outsourced models)—unpack day-to-day hurdles and turn them into workable, inspection-ready solutions.
- Co-author open-access resources—guidance briefs, infographics, checklists—that any organisation can apply immediately.
- Monitor related work of other organizations (e.g., ACRO, PHUSE, TransCelerate, ICH) and liaise as necessary to focus on significant unaddressed industry gaps.
Director at Dorricott Metrics & Process Improvement Ltd | Lead Instructor, MyRBQM Academy
Need a Hand? Meet Keith
SCOPE Summit Florida
RBQM Needs Oversight - A Practical Approach
The EWG developed practical learning resources to support right-sized RBQM oversight, enabling teams to adjust oversight levels based on trial performance, whether RBQM is outsourced or managed in-house.
Date:
February 4th, 2026
The EWG operates autonomously, with operational facilitation from Cyntegrity.
Our Members
Toncika Bago
Sr Risk Based Monitor at ERGOMED
Brian Barnes
Director, Risk Management
Strategy at BioNTech
Dr Efterpi Kardalinou
University Medicine Essen (UME) Studieneinheit
Sponsor Oversight Coordinator
Leslie Sam
President at Leslie Sam and Associates, LLC
Johann Proeve, PhD
Chief Scientific Officer
at Cyntegrity
Bethann Schrader-Giancarlo, MS
Director Data Management -
Prophylaxis Program Lead at Pharvaris
Alec Vardy
Unicon Pharma,
assigned to Cytokinetics
Linda White
Associate Dir Risk-Based Quality Management
at Jazz Pharmaceuticals
Keith steers the mindsON RBQM Expert Working Group. He is a recognized industry expert in QbD and RBQM and has a background in manufacturing, CROs, and consultancy to sponsors, service providers, and consortia.
DIA Global Forum
Publication | Launching the mindON RBQM Working Group
The mindsON EWG’s path from discussion to actionable RBQM oversight outputs.
Read: