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Breakfast Seminar: Reduce Site Monitoring Costs with a Risk-based Approach
Dear %%First_Name_%%,
Are
you aware that 100% source document verification (SDV) is not required
by regulatory agencies? Are you considering adopting a risk-based
monitoring approach, but are struggling with what tools and processes
need to be in place? Are you curious to know how industry leaders have
successfully conducted clinical trials with less than 100% SDV?
If you answered yes to any of the above, join us for this informative seminar to learn how:
- Industry experts interpret updates from regulatory agencies;
- Innovative sponsors use a risk-based approach of 15-20% SDV; and
- Medidata’s platform paves the way to adopt risk-based monitoring and streamline monitoring processes.
Date: Tuesday 19th June, 2012 | Time: 09:00 - 13:00 BST
Location: etc Venues Paddington, 57 North Wharf Road, Paddington Basin, London. W2 1LA
| Time |
Agenda |
| 09:00 |
Arrival, Registration & Breakfast |
| 09:30 |
Welcome & Introductions |
| 09:00 |
Regulation Review: FDA & EMA Guidelines, the Opportunities & Obstacles
Tony Hewer
Sr. Director, Quality and Regulatory Affairs
Medidata Solutions |
| 09:00 |
Data integration & modelling solutions to enable risk-based assessment & centralised monitoring
Jon Davidson
General Manager
d-Wise Technologies UK Ltd |
| 09:00 |
Implementing a Total Data Quality Plan in Clinical Trials
Vanessa Tierney
Clinical Operations Professional |
| 09:00 |
Coffee Break |
| 09:00 |
Enable Risk-based Approach with Centralised Monitoring & Streamlined Execution
Emily Carole Moore
Executive Director and Site Head, Data Operations EUAP
INC Research |
| 09:00 |
Medidata's Risk-based Platform: Site Quality Management, Targeted SDV & Monitoring Reporting
Richard Young
Director, Regional Sales
Medidata Solutions |
| 12:30 |
Question & Answer Session |
| 13:00 |
Adjourn |
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If you have questions regarding this complimentary event, please contact:
Rachel Lowrey, [email protected] / +44 (0)1895 275695 |
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