Stay Informed
Our Members
Toncika Bago
Sr Risk Based Monitor at ERGOMED
Brian Barnes
Director, Risk Management Strategy at BioNTech
Shruti Diggavi
Consultant (QA/QC, RBQM, and Centralized Monitoring, Medical Writing, GenAI)
Stefan Hiess
Head of Digital Operations at Cyntegrity
Dr Efterpi Kardalinou
University Medicine Essen (UME) Studieneinheit Sponsor Oversight Coordinator
Mathias Milici, PhD
Central Monitoring Head at Novartis
Johann Proeve, PhD
Chief Scientific Officer at Cyntegrity
Leslie Sam
President at Leslie Sam and Associates, LLC
Bethann Schrader-Giancarlo, MS
Director Data Management - Prophylaxis Program Lead at Pharvaris
Amandeep Sonik
Senior Director- Risk Pillar Head, Centralized Monitoring at Thermo-Fisher PPD
Alec Vardy
Unicon Pharma, assigned to Cytokinetics
Linda White
Associate Dir Risk-Based Quality Management at Jazz Pharmaceuticals
mindsON RBQM Experts
Working together for the community.
Stay Informed
Q3 2026 Update:
Advancing Practical KRI Implementation
The mindsON RBQM Expert Working Group continues to grow, now with 140+ followers and an expanding group of active contributors.
This quarter’s focus is on study-specific KRIs, where teams face challenges across process, technical feasibility, and alignment. The group is developing a practical process map from KRI identification to evaluation at study close, now progressing toward best practice guidance, with further outputs planned.
A recent session also explored how AI can support parts of this process in a practical way.
DIA Global Forum
Publication | Launching the mindON RBQM Working Group
The mindsON EWG’s path from discussion to actionable RBQM oversight outputs.
Read:
The DIA Spotlight
Let's Meet at SCOPE Europe
The mindsON RBQM Expert Working Group will be at SCOPE Europe 2026, bringing our community discussions into a live industry conversation.
If you’ll be attending, we’d love to meet you. Join our panel discussion, connect with members, and continue the conversation around practical RBQM implementation.
Panel Discussion
Helping to Ensure Your Study-Specific KRIs Are Up to the Job
14 October 2026
Events & Calendars
Stay connected with upcoming events, webinars and community activities across the mindsON RBQM community.
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
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.
The EWG operates autonomously, with operational facilitation from Cyntegrity.
Need a Hand? Meet Keith
Keith Dorricott, MBB
Director at Dorricott Metrics & Process Improvement Ltd | Lead Instructor, MyRBQM Academy
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.
