Developed an outsourcing strategy for a large pharmaceutical company to conduct effective clinical studies

Case Studies:Mu Sigma
Published On: 28 July 2016
Views: 5882

What We Did:  Enabled the client with an outsourcing strategy for conducting effective clinical studies


The Impact We Made: With the new outsourcing strategy, productivity of clinical studies was improved, leading to 2% cost savings


Summary - Outsourced clinical trials

The client, a leading pharmaceutical company has a rapidly growing portfolio, owing to many molecules in the development pipeline. However, budget constraint for conducting clinical trials was proving to be a challenge. Mu Sigma suggested that outsourcing the clinical studies will be cost effective. A strategy was developed, in harmony with the marketplace, where certain studies and activities were outsourced. The strategy was not only effective and less time consuming, but also led to 2% cost savings for the client.


About The Client - Large pharmaceutical company

The client is one of the leading pharmaceutical company in the world which manufactures prescription drugs across several therapeutic areas like diabetes, internal medicine, oncology, etc. The client’s portfolio also includes some Over The Counter (OTC) drugs.


The Challenge - Lacked quality & a holistic approach

Although there is significant rise in pharma companies that outsource their studies, the exercise lacked the following:

  • An integrated approach towards the project, focused on measuring success

  • Feedback incorporation for refinement of future strategies

  • Data was still dispersed and quality was unreliable


The Approach - Efficient data collection and operational analysis

Mu Sigma took a structured approach to better plan and execute the clinical trial outsourcing strategy:

  • Various operational activities were bucketed into groups

    • Study planning, study mix, execution, FTE utilization and vendor management were major groups

    • KPIs were identified for each of the group

  • A hypotheses matrix was created and required variables were mapped

  • Then Analytical Data Set (ADS) were prepared, followed by hypotheses testing

  • Various analytical models of cross correlation, regression analysis and time series were run to analyze operational areas/ groups

The findings helped the client improve their overall clinical trial process and also set realistic expectations from the outsourcing partner.


The Outcome – Successful partnership

Mu Sigma’s recommendations helped the client identify outsourcing models which worked best for different studies:

  • Improved project planning and shortened timelines by 12%

  • With relevant metrics, productivity of clinical trials was improved and led to 2% cost savings

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