Thursday,October 10, 2013 | Archive Now Available
Effective monitoring of clinical investigations is critical to the protection of human subjects and the conduct of high-quality studies. Clinical investigations involving human drugs, biological products, medical devices, and combinations thereof are required to provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the clinical trial data submitted to FDA.
During the past two decades, the number and complexity of clinical trials have grown dramatically.
These changes create new challenges to clinical trial oversight, particularly increased variability in clinical investigator experience, site infrastructure, treatment choices, and standards of health care.
This webinar will cover the following with in-depth discussion on:
1.Ensuring the rights, safety of trial subjects
2.Data integrity & management
3.How much monitoring of clinical trial sites is necessary to ensure quality, compliance, and safety of research participants?
4.How to go from 100% source data verification to a risk-based monitoring
5.Increasing the effectiveness of clinical trial site monitoring
6.Cost reduction and improved data quality?
A live Q&A with the audience will follow the main presentation.
Mark Travers, VP, Head of Clinical Study Units at Sanofi-Aventis
Mark was born and educated in Glasgow, Scotland. Honors Degree in Biochemistry and PhD in Bioengineering from the University of Strathclyde in Glasgow & 2 years post-doctoral research in chronic and acute renal failure at the royal Infirmary in Glasgow. MBA in general management from the University of Sussex in Brighton.
Mark moved to Wuppertal (Germany) in 1988 to work with the fibers and Polymers division of Enka (an Akzo company) in the area of clinical Research and Scientific Marketing.
In 1990, Mark moved to London as a Clinical Research Associate (CRA) with Yamanouchi working on an alpha blocker for BPH. Now lunched in the US as FlowMax.
In 1992, he joined the Janssen Research Foundation (Johnson & Johnson) as a senior Project Manager working in the areas of CNS, Neurology and Pain control. Progressed through various management positions to reach the position of R&D Director for the UK, Ireland and Israel and a position on the UK Management Board.
In 2001, he moved to Johnson & Johnson in the US as Head of Global Trial Management for the Global Clinical Operations organization responsible for training and managing Global Trial Managers (GTMs) who in turn managed all of the Phama’ groups clinical trials from Phase 1 through to Phase IV. In 2006, promoted to the position of VP, Head of Clinical Trial and Site Management for the Americas Region – Canada, US and Latin America.
In 2010 he moved to Sanofi to take up the position of VP, Head of the Clinical Study Units. The CSU organization sits within the Clinical Sciences and Operations platform of Sanofi R&D. The CSU consists of over 1700 people in over 40 countries managing and monitoring clinical trials in over 70 countries.