Establishing a reduced source document verification (SDV) strategy is not as simple as it sounds. How do you ensure data quality remains high when SDV is significantly reduced? And how do you determine which data gets verified and which doesn’t?
Join this complimentary webinar to hear TransCelerate and Medidata discuss the results of a data-driven analysis on the relative effectiveness of SDV—which will be published in the November 2014 issue of Therapeutic Innovation & Regulatory Science (TIRS), the official journal of DIA—as well as learn how to turn the findings into real-world practice.
During this one-hour session, the experts will also share:
- An overview of the analysis, methods and results;
- How to apply the results to your risk-based monitoring study design; and
- What’s next on TransCelerate’s RBM agenda.
Stephen Young, Principal Engagement Consultant, Medidata
Stephen Young brings more than 20 years of experience to his role as principal engagement consultant at Medidata Solutions. Since joining the company in 2010, he has led the development of Medidata’s insights and site monitoring solution portfolios, providing customers with turnkey metrics and analytics-driven solutions to improve site monitoring workflows. Previously, he headed eClinical services for J&J Global Clinical Operations. He holds a BS in mathematics from St. Joseph’s University and an MS in mathematics from Villanova University.
Andy Lawton, Global Head of Clinical Data Management, Boehringer Ingelheim
Andy Lawton has extensive experience in Computing, Statistics, Data Management, RDE/RDC, System Design, RBA in CSV and Clinical trials. He has previously worked with Seismic Exploration (1971-1972) and National Health Service (NHS) – Consultant Statistician (1979-1984) and is currently at Boehringer Ingelheim (1984 – present). He became the Global Head of Clinical Data Management on 1st Jan 2013. This is a new strategic role within BI responsible for SOPs, Governance of processes/systems and new initiatives in the CDM area.
Beyond that, Andy is a Founding Committee Member of ACDM, Member of TransCelerate RBM work stream and a Member of EFPIA WG on Data Transparency. His most notable publication is the paper with Dr. Alistair Ross on GP Audit – throughout 80’s and 90’s this was the most quoted paper in the BMJ.
Mark Travers, Vice President, Head of Clinical Study Units, Sanofi
Born and educated in Glasgow, Scotland. Honors Degree in Biochemistry and PhD in Bio-engineering 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.
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, moved to London as a Clinical Research Associate (CRA) with Yamanouchi working on an alpha blocker for BPH. Now launched in the US as FlowMax.
In 1992 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, 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 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.
Who Should Attend?
Senior level professionals involved in clinical operations for pharmaceutical and biotechnology companies
Medidata Solutions is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud™ brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of our global customers, which include over 90% of the top 25 global Pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.