Risk-Based Monitoring – What We’ve Learnt in a Year, a Large Pharma Perspective From Sanofi

Clinical Trials, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • May 28, 2014

Hear from Sanofi Aventis how intelligent Central Statistical Monitoring techniques have been harnessed to improve data quality and oversight. This session will also showcase the impact that Sanofi has had on enhancing this technology-driven approach.

Sanofi started to investigate general issues around scientific misconduct back in 2008 with IDDI (CluePoints’ parent company) and then implemented CSM with CluePoints since 2012.

Keywords:

Speakers

Eric Genevois-Marlin, Vice-President of Biostatistics and Programming, Sanofi

Eric holds a degree of statistician from institute of Statistics from university of Paris (ISUP). Over the past 23 years, he worked as a clinical statistician at Rhone-Poulenc-Rorer which became Aventis, and joined Sanofi 10 years ago. He worked on multiple therapeutic domains, including anti-infective, oncology, cardiology/Thrombosis, neurology from phase I to phase IV. He is now Vice-President of Biostatistics and Programming at Sanofi.

Francois Torche, CEO, 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.

Karen Fanouillere, Biostatistics Project Leader, Sanofi - Biostatistics & Programming

Karen has 14 years industry experience as biostatistician, after holding a degree of statistician from then Institute of Statistics from university of Paris (ISUP). She started her career mainly on Neurological and Psychiatric projects before joining Sanofi in 2006 as biostatistician project leader on cardiology/Thrombosis area. She is currently working on a vaccine program within Sanofi-Pasteur.

Who Should Attend?

Senior level executives from companies currently conducting clinical trials

  • Pharmaceutical
  • Biotechnology
  • Medical Device
  • CROs

Xtalks Partners

Cluepoints

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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