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The Workshop
| Pre-Conference Workshop |
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About the workshop: |
Optimising the process efficiency and cost effectiveness of an e-clinical trial
Monday 22nd May 2006, London, UK
Led by:
David Dworaczyk
King Pharmaceuticals |
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As the industry is moving towards a fully-implemented electronic clinical trial system, many companies are making the mistake of simply swapping paper over to EDC without reviewing the key roles of the clinical groups within the clinical trial process. Another challenge companies face is justifying and measuring the cost-effectiveness of an e-Clinical trial as well as gaining maximum benefits from the technology. This workshop will identify some of the common pitfalls of implementing EDC without process change and then lead you through an optimal EDC workflow, highlighting tried and tested systems, and identifying the roles that need to be changed internally. The workshop will uniquely involve a mix of Big Pharma companies and EDC vendors presenting and addressing the key concerns and preconceptions around EDC implementation for you to gain maximum insight and knowledge of effective EDC implementation procedures and industry best-practices from leaders in the field. |
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| Speakers include: |
| Leonie Christianson |
Global Clinical Operations |
GlaxoSmithKline |
| Elaine Job |
Executive Director, Data Management |
Covance |
| Gary Tyson |
Vice President |
Campbell Alliance |
| Graham Bunn |
Vice President, Strategic Alliances |
Medidata |
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| Workshop agenda: |
| 14:00 |
Registration |
| 14:30 |
Session One |
- Paper vs. e-Clinical: effectively using EDC data for optimising efficiency and cost effectiveness
- Comparing and contrasting the study start-up practices for a paper and an EDC trial
- Re-defining the approach: making sure that you don’t simply try to “e” a paper process
- Re-engineering an entire study start-up process: what has to change internally to make EDC work to get the benefits expected?
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| 15:30 |
Refreshments |
| 16:00 |
Session Two |
- Creating actual metrics to measure the cost and time benefits of using an EDC approach rather than a paper approach
- Analysing the results: is there real data to show that EDC is cheaper than paper?
- Are some studies better run with paper than EDC?
- Analysing the examples where it is assumed that paper is better and understanding the results
- What can you get with paper that you can’t get with EDC or the other way around?
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| 16:45 |
Session Three |
- Perceptions vs. facts: defining and addressing concerns on EDC implementation
- Defining the actual concerns and reluctance of some manufacturers to why they don’t want to use EDC
- Looking to the next level, why EDC is only a starting point for effective use of technology in a heavily paper driven and isolated process within a Big Pharma company
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| 17:30 |
End of workshop |
| Supported by: Medidata |
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About your workshop leader: |
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David A. Dworaczyk has direct responsibility for the global clinical development of the King R&D project/product portfolio (Phase I-IV) as well as new business strategic assessments. Prior to joining King Pharmaceuticals, Inc., Dr. Dworaczyk was at AAI Pharma, as Sr. Vice President Clinical Services and Quintiles, where he was Vice President of North American Clinical Operations, and then Sr. Vice President of Integrated Technologies where he had global responsibility for two technology based business units. In addition, he was responsible for identifying and implementing the effective use and application of various technologies across the organization for improvement of internal operational efficiency, improved quality and increased customer service. |
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