* Rationalized Study/Research Plan

• Approach validation, project design integrating existing internal research activities,
• State of existing resources and means of outsourcing,
• Support establishment of an integrated and rationalized project,
• Support choice of technologies and resources (internal versus external),
• Our knowledge of national and worldwide CRO market
• Project design and execution within budget.

* Writing URS and specifications…

• Phasing of the project if necessary
• Collecting expectations of the scientists and of the project’s sponsors
• Implementation of applications to enable and support informed decision making
• Precisely define functional needs
  • Which kind of data are expected, what are the questions?
  • Project’s extent and limits
  • Priority identification and ranking.

• Evaluate needs and, if necessary, identify outsourcing strategy and partners
• Evaluate outsourcing costs/benefits
  • Suggest outsourcing platforms
  • Seek competitive offers
  • Decisions and preparation of contract,
  • Project Realization: Define actions and individual responsibilities within a precise time plan.
    

• Project plan, time lines, alternative approaches in case of difficulties
• Writing the final URS by PharmaBio