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Health Services

Case Study – Health Care Sector - Clinical Trials

health_case_studyCustomer request / needs:

The client is a Company based in the USA specialised in running clinical trials, outsourced by pharmaceutical companies in the US.

 


A typical trial is made up of:
1. Protocol, the new drug to be tested.
2. Sites, which are the medical centers that agree to find patients to try the new drug,
3.
Controllers, which are people from the company visiting the sites and collecting the evidence of how the drug is working or the patients.

The target was to improve the quality of the service provided to one specific outsourcing company, with the goal of becoming best in class in clinical trials and win other pharmaceutical contracts over competitors.

Overall Goals of the project:

The goal of the Project team was to provide a quick but accurate assessment of the current clinical trials process. The assessment would include:

  • Capacity Models 
  • Input / Output Analysis 
  • Value stream maps Recommendation for “Future State” Capacity solution.

Specific goals of the project were:

  • Increase the speed of completion of the clinical trials / Assure on time completion of the clinical trials;
  • Increase the quality of the data collected from the patients and assures timely transmission back to the pharmaceutical companies for drug effectiveness analysis.
  • Reduce cost of trials management, specifically:
    • cost of travel to sites for data monitoring,
    • cost of low patients enrolment levels

 Analyse:

 From the analysis of the value stream map and the data provided at a regional level for the capacity and demand, we were able to define the following opportunities for improvement:

  • Track
  • Develop/Improve sites approval process to avoid protocol delays from the outset;
  • Develop site plan at site approval, which the site would be held accountable for;
  • Measure sites performance against plan and react quickly to poor site performance;
  • Visit sites based on data collected;
  • Use data to estimate time required for data verification 􀍴 and forecast site visits based on this;
  • Broaden the skills set of the controllers and improve knowledge and sharing of work within regions.

 Improve:

 We developed a new planning tool to help monitor the performance of the sites within each protocol.This tool works at different levels:

  • At a controller and site level,
  • At a management level:
  • At a Company level:

The tool was piloted on 1 protocol to understand the impact to a trial and to ensure the improvement was controllable due to the sheer geographical spread of sites and controllers across Northern America.

Project Results:

The pilot is delivered impressive results. Having the tools to manage the controllers and the ability to respond quickly when site performance drops, has given the protocol owners, the clarity they need to make fact based decisions. The planning tool we designed is being progressed into an online system and will be one of the first tools in the space of clinical trials management.