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[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Innovation in Therapeutic Areas ,[object Object],[object Object],[object Object],[object Object],[object Object]
Pipeline Merck as of Nov11
Les essais cliniques internationaux  et leur monitoring : Quels sont les facteurs clés de succès ? 
Présentation RPS ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New Model
Les essais internationnaux multicentriques ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Summary
Changes in R&D Models ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Significant Geographic Shift  of Clinical trials to Asia Pacific Region Source: Jefferies & Co. Inc. Survey of Outsourcing Biopharma R&D Professionals, April 22, 2008 Confidential
Outsourcing Strategies to the CROs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Projects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Projects – Conduct ,[object Object],[object Object],[object Object],What is Most Difficult : Local or Global Studies ? ,[object Object],[object Object],[object Object],Local Global
Projects – Monitoring Visits Interim Monitoring Visit Europe China Preparation Travel Time Onsite Time MVR and Follow Up 2h 8h 8h 4h 4h 15h 27h 6h Example  of differences
Difference in Cultures ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Difference in Cultures ,[object Object],[object Object],[object Object],[object Object]
International Monitoring ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
International Monitoring ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
International Monitoring ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Atelier 2 : Essais cliniques internationaux quels sont les facteurs clés de succes

  • 1.  
  • 2.
  • 3.
  • 4. Pipeline Merck as of Nov11
  • 5. Les essais cliniques internationaux  et leur monitoring : Quels sont les facteurs clés de succès ? 
  • 6.
  • 8.
  • 9.
  • 10. Significant Geographic Shift of Clinical trials to Asia Pacific Region Source: Jefferies & Co. Inc. Survey of Outsourcing Biopharma R&D Professionals, April 22, 2008 Confidential
  • 11.
  • 12.
  • 13.
  • 14. Projects – Monitoring Visits Interim Monitoring Visit Europe China Preparation Travel Time Onsite Time MVR and Follow Up 2h 8h 8h 4h 4h 15h 27h 6h Example of differences
  • 15.
  • 16.
  • 17.
  • 18.
  • 19.

Editor's Notes

  1. 2 Slides pour une présentation succinte de MSD France, à insérer selon filage prévu
  2. 4eme point noté « International Monitoring » sur les dernières slides, à harmoniser ?
  3. Je vous laisse cette présentation comme convenu, que je peux bien sûr appuyer ou relancer si questions.
  4. Dommage que ces slides ne mentionnent pas l’Amérique du sud qui en terme d’essais cliniques, est en forte croissance. Les chiffres ne sont pas aussi marqués pour ce qui nous concerne, chez MSD (de 51 à 26% de 2008 à 2011 mériterait une vérification …)
  5. Se mêle à ces considérations une question de Culture d’entreprise, d’expertise : pour simplifier, pour certaines activités (monitoring, ou autres…) un promoteur n’a pas forcement de valeur ajoutée dans l’excellence de la conduite de celles-ci, par rapport à vos structures et peut d’autant plus se concentrer sur des projets/tâches où il misera son expertise.
  6. Claire flexibilité sur le Global et une mise en place accélérée en local
  7. Le titre « Projects Monitoring Visits » ou sommes nous déjà dans la différence de culture ?
  8. Pour précision, le Clinical Research Manager est line manager chez nous des CRAS et des Project Managers, leur rôle est ainsi le management de collaborateur et l’overview de projets locaux ou globaux
  9. Ci-joint donc une slide supplémentaire sur les Sponsor Expectations pour les CRAs qui peut conclure celle-ci, à voir.