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Case Study - Clinical Resourcing

Resource capacity planning model adds value to big pharma

Problem:
Clinical Research division of a large pharma company was looking for a management consultant to critically analyze the existing human resource capacity planning model with a view to identifying gaps and recommending areas of improvement for resourcing Clinical Research Associates (CRA’s) and project managers.

Approach:
After a meeting with the various stakeholders who would be potentially impacted by this analysis, the project scope was defined and the following goals were set:

There was a need to scientifically validate the FTE allocations that were traditionally used to make capacity assessments
It was determined that the Clinical Department lacked the ability to reliably forecast CRA capacity for upcoming studies and this would need to be an area of focus
There was anecdotal evidence of the presence of frustration between the two sub-specialties of the CRA function (project managers and site managers (CRA’s)) due to a confusion of roles and responsibilities.

With this framework in mind, the project was divided into three phases each approximately 3 months in duration. The initial phase included internal and external benchmarking and the definition of project scope and deliverables. In the second phase, the CRA Task List was completed and data collected in a pilot study using a prospective timesheet. In the final phase, multivariate linear regression analysis coupled with inferential statistics was used to critically appraise the current model and derive a new model for capacity planning.

Recommendations:
This project was able to achieve all three deliverables within the timeframe set forth in the work plan.

The project outcomes included:

Scientific validation of the existing model and the construction of a detailed FTE Allocation Template to assist managers in making capacity assessments for CRA’s at a level of detail that did not exist before
CRA Roles and Responsibilities Task List was designed to help clarify roles and responsibilities and job descriptions.
A new resourcing model using Microsoft Access Platform architecture was developed and this model enabled the use of computer-based forecasting tools to predict future CRA capacity.

Results:
As a result of changes implemented, the clinical department realized substantial savings in departmental OPEX and employee frustration was tangibly reduced due to better FTE allocations.