Removing the “Risk” in Risk-Based Monitoring – What We Have Learnt in the Last 4 Years from the Practical Implementation of RBM

Drug Discovery and Development, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Monday, September 12, 2016

This session details best practices for onboarding RBM that have been gained through implementation involving smaller and larger BioPharma sponsors and CROs.

The presenters will showcase the benefits derived from an integrated solution featuring upfront Risk Assessment, Overall Data Quality Oversight, Key Risk Indicators (KRIs) and the process to drive Targeted Monitoring and Source Data Verification (SDV). They will describe the process, people and technology elements that make for the successful planning and execution of RBM, revealing how best to enable your organization to embark on your RBM journey – taking what on the surface appears complicated and making it much more straightforward.

The webinar will:

  • Highlight best practices for RBM study planning and execution and key pitfalls to avoid
  • Draw a clear line of sight between study risk assessment, operational KRIs, and quality oversight methods
  • Capitalize on the best use of data analytics in central data review
  • Determine how to integrate RBM technology within the new operational process


Francois Torche, Chief Executive Officer, CluePoints

François holds a Master in Business Administration from the ICHEC School of Management, Brussels. Over the past 15 years in the Pharmaceutical industry, he has held positions as statistical programmer, SAS and JAVA developer and IT project leader for companies such as GSK, UCB and IDDI. During his ten year tenure with IDDI as an IT Specialist, Mr. Torche assisted in the development of the SMART™ engine, a patent-pending software solution and the underpinning of CluePoints. Francois has served as CluePoints’ Chief Executive Officer since the company’s inception in 2012.

Message Presenter

Craig Serra Senior Director, Data Management BPO, Clinical Sciences and Operations, Pfizer

Craig Serra is Senior Director and Leadership Team member within Data Monitoring and Management, and Business Process Owner for the data management conduct and closeout process area with accountability for the process across the portfolio of 350+ Pfizer interventional clinical trials. He has over 14 years of experience in Data Management, Clinical Systems, and Strategic Operations, in mid-to-large pharma and small CRO organizations. Prior to re-joining Pfizer, Craig worked at DSP Clinical Research, in both business and biometrics leadership roles. Previous to that, he held project, program, portfolio, and business leadership roles at Pfizer, Roche, Eisai, Schering Plough, and Everest Clinical Research. Craig has been involved in several industry consortia, contributions to white papers/blogs for RBM, and presentations at various conferences. Craig has certifications in data and project management, with a BA in Psychology from Rutgers University, both an MBA in Management and an MS in Information Systems from Fordham University, and an MS in Pharmacology and Toxicology from Michigan State University.

Message Presenter

Who Should Attend?

  • Clinical Operations
  • Data Management
  • Biostatistics
  • Quality Assurance
  • Regulatory

Xtalks Partner


CluePoints is a Central Statistical Monitoring solution that employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial data. By identifying anomalous data and site errors, corrective actions can be taken ensuring data quality and a reduction in overall regulatory submission risk.

Aligned with guidance from the FDA and EMA, CluePoints is deployed to support traditional on-site monitoring and can be implemented as the engine to drive a risk-based monitoring strategy.

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