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Implementing a Risk-Based Quality Management Strategy – The Ultimate Guide

By December 10, 2019March 9th, 2022No Comments

Every organization faces unique challenges when it comes to implementing a Risk-Based Quality Management strategy. There’s no ‘one-size-fits-all’ approach that will ensure success, as each organization has specific influencing factors such as therapeutic areas, existing processes, and various technologies. Our latest guide, produced by our Chief Scientific Officer, Steve Young, takes a look at considerations for ensuring not only a successful rollout but its scalability across the enterprise and:

  • The importance of Risk-Based Monitoring/ Risk-Based Quality Management.
  • Best practices based on lessons learned from actual Risk-Based Quality Management initiatives.
  • How to establish your business objectives.
  • Defining your RBQM approach.
  • Managing the change.
Download the Guide


As Chief Scientific Officer for CluePoints, Steve oversees the research and development of advanced methods for data analytics, data surveillance and risk management, along with providing guidance to customers on RBQM methodology and best practices. Steve worked for three biopharmaceutical companies over a span of 15 years where he assumed leadership positions in clinical data management and led the successful enterprise roll-out of EDC at both J&J and Centocor. He spent an additional 6 years with eClinical solution providers Medidata and OmniComm, leading the development of analytics and risk-based quality management (RBQM) solutions and providing RBQM consultation to many organizations. Steve also led a pivotal RBM-related analysis in collaboration with TransCelerate, and is currently leading RBQM best-practice initiatives for several industry RBM consortiums. Steve holds a Master’s degree in Mathematics from Villanova University.


CluePoints offers Sponsors and CROs a better way of identifying, visualizing, managing, and documenting trial risks that could compromise patient safety and delay the approval of Investigational Products. Underpinned by Central Statistical Monitoring, a technique that’s currently being investigated by the Food and Drug Administration (FDA) for selecting sites for inspection, our cloud-based Risk-Based Quality Management software is deployed to support traditional onsite monitoring, medical review and quality to drive a Risk-Based Approach to Study Execution (RBx) and ultimately, to achieve ICH E6 (R2) compliance.

Patrick Hughes

Patrick holds a Marketing degree from the University of Newcastle-upon-Tyne, UK, and a post-graduate Marketing diploma in Business-to-Business Marketing Strategy from Northwestern University - Kellogg School of Management, Chicago, Illinois. Responsible for leading global sales, product, marketing, operational and technical teams throughout his career, Patrick is a Senior Executive with over eighteen years international commercial experience within life sciences, healthcare and telecommunications. In the past, Patrick consulted on corporate and commercial strategy for various life sciences companies and was responsible for successfully positioning ClinPhone as the leading Clinical Technology Organization during his 10-year tenure with the company.