Realising the True Benefits of Risk Management with Brian Barnes
In this sponsored episode, originally produced as part of CRScube’s Clinical Data Talks podcast, we’re pleased to share a compelling conversation hosted by Sylvain Berthelot, VP of Strategy and Marketing at CRScube. Sylvian welcomes Brian Barnes, Director of Risk Management Strategy at BioNTech, to explore the human and strategic dimensions of risk-based quality management (RBQM).
Drawing from his rich experience across CROs, technology vendors, and now a sponsor organisation, Brian shares how his role as a “risk assessment facilitator” reflects a broader cultural shift: developing a company-wide risk-focused mindset and moving risk management upstream into study design and operational planning. Sylvain and Brian talk about building risk frameworks from the ground up, demonstrating return on investment for RBQM and confronting resistance and misconceptions. Brian offers practical insight into why RBQM is less about the tools and more about people, collaboration, and culture.
Tune in to discover what “good” risk management looks like and how to make it stick –across teams, trials, and organisations.
Meet the Guests
Brian Barnes
Director of Risk Management Strategy, BioNTech
Brian is a seasoned leader in clinical research, specializing in Good Clinical Practice (GCP) process excellence, risk-based quality management (RBQM), and global clinical operations across a range of therapeutic areas. With over two decades in pharmaceutical R&D, he has held pivotal roles at BioNTech, Medidata, and PPD, where he has driven global strategy, led cross-functional teams, and integrated innovative technologies—including AI—into clinical trials. His expertise lies in enhancing data integrity, supporting participant safety, and optimizing operational quality.
Sylvain Berthelot
VP of Strategy and Marketing, CRScube
Sylvain has spent 20 years providing software to the pharmaceutical industry, with 15 years specializing in clinical trials at various eClinical technology vendors. As VP of Strategy and Marketing at CRScube, he champions the company’s mission to make clinical trials more accessible. He’s also passionate about patient advocacy, raising awareness through his podcast On One Condition.
About CRScube
At CRScube, our goal is to make clinical trials accessible to everyone.
We offer a comprehensive suite of cost-effective eClinical solutions, meeting the requirements of regulatory agencies worldwide. Our products are quick to learn, easy to use and help our clients be more efficient in clinical data capture and analysis.
Our unified platform has been used on over 5,400 trials, by 1,000+ clients across pharma, biotech and CRO companies.
Our solutions revolve around cubeCDMS, our flagship EDC system, and include IWRS, ePRO, eConsent, RBQM etc. With a truly unified approach, our solutions exchange data seamlessly to reduce data redundancy, remove the need for data reconciliation, and increase data quality.
To learn more visit: https://www.crscube.io/
