Tuesday February 14th, 2012
13:30 PM - 17:30 PM
Microsoft France
39 Quai Prés Roosevelt,
92130 Issy-les-Moulineaux, France
Tél : +33 1 57 75 10 00
Microsoft, Accenture and NextDocs are pleased to invite you to a free seminar for half a day on the benefits of clinical trial management using SharePoint and the feedback of such a project carried out at Sanofi : http://www.microsoft.com/casestudies/Case_Study_Detail.aspx?CaseStudyID=4000010130
Today, pharmaceutical companies face many pressures and constraints including phase clinical trials. Estimated average costs of clinical trials in Phase I are around $20 million against $100 million in Phase III. Therefore, pharmaceutical companies and CROs are trying to optimize their operations by reducing the time and resources to carry out their tests, including removing manual tasks and paper handling.
The implementation of a computerized collaborative work platform allows us both to accelerate the creation of a study and the formation of TMF but also to avoid re-keying of information. It provides an opportunity for investigators to enter data directly on the website of the sponsor while ensuring regulatory compliance with electronic signature and approval circuits. ETMF system and a portal for their investigators ensure the effectiveness and the overall vision of the data they process daily.
In this presentation you will learn how to reconcile respect for the quality and confidentiality, reducing administrative workload of clinical trials, dematerializing of the TMF and the reports sent by the investigators.
Session Agenda:
| Time |
Topic |
13:30 – 14:00 |
Registration |
14:00 – 14:15 |
Introduction
Microsoft Strategy to manage Industry Challenges.
(Philippe de Batz, Microsoft)
|
14:15 – 14:30 |
Compliance without Complexity - 21CFR11 Compliant Document and Quality Management for Life Sciences (Orang Gholikhani, NextDocs)
- Company and Strategy Overview
- Document & Quality Management System
- Regulatory Submission, SOP, Clinical Trial
- Interoperability & Integration
|
14:30 - 15:30 |
Feedback from Sanofi Project (Vincent Le Vaslot, Accenture)
- Business benefits
- Investigators, Sponsors
- What Should be avoid
|
|
|
15:30 – 15:45 |
Coffee Break |
15:45 - 16:45 |
Demonstration of NextDocs Clinical Module (Christophe Benninghoff, NextDocs)
|
16:45-17:30 |
Round Table :
- All questions would be answered by Denis CARDINAL Sanofi R&D Clinical IT Project Manager
|
|
|
Tuesday February 14th, 2012
13:30 PM - 17:30 PM
Microsoft France
39 Quai Prés Roosevelt,
92130 Issy-les-Moulineaux, France
Tél : +33 1 57 75 10 00
Register:
For more information you can contact :
Orang Gholikhani
orangg@nextdocs.com ou +33 601168839