Project Description

The challenge

A leading global vaccines business sought to transform its Clinical Operations to bring performance in line with its overall mission.

The Clinical Operations team needed to be assessed for its suitability in a more project focused organisation and ensure it was flexible enough to cope with future demands.

The team was challenged by:

  • Poorly defined roles and responsibilities.

  • A lack of clarity of decision making authority

  • Complex and inconsistent processes and systems.

  • A lack of basic management information.

  • Inconsistent delivery of change efforts.

  • Inconsistent and complex global, regional and local structures.

Our approach

We conducted a series of diagnostic interviews, with employees within Clinical Operations and with other stakeholders in the rest of the organisation, to identify key areas for improvement.

As a result, joint client-Kinapse teams were put in place to design solutions for each area of improvement. That included creating deliverables such as a RACI, a CRO governance model, scientific and operational health checks for clinical studies.

We agreed priorities with the programme sponsor and supported their implementation. We also detailed our implementation and communication plans, as well as supporting the delivery of training.

The result

Now, the client’s Clinical Operations team is more customer focused, more flexible, more efficient and more productive.

The transformation has achieved annual savings exceeding €15 million and Kinapse continues to provide consulting support for the implementation of the proposed solutions.

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