Regulatory Affairs & Product Development Services

The Application of Strong Scientific Understanding

Scenario planning

The completion of a fully-integrated global project plan will also allow the outcome of different scenarios to be determined. Scenario planning is useful for senior management to make strategic product development decisions, and also serve as a communication tool for internal stakeholders to the project team.

a well-constructed project plan can be used to answer senior management questions

For example, answers to questions such as:

  • what will be the impact of delaying the pivotal clinical trial by 3-months to the final delivery date?
  • How could costs and resources be phases to optimise output?
  • How will different regulatory approval timelines impact on product launch plans?
  • If patient trial recruitment in the pivotal clinical study is falling 10% behind plan how much additional stability data could then be included in the submission?
  • How many additional clinical sites would need to be initiated to bring the trial on-track, and what would be the cost and resource implications?

In essence, a well-constructed project plan can be used to answer senior management questions. BioVentures Consulting Limited is able to discuss and address these questions with you and develop the different scenario outputs for strategic decision-making.

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