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Case Study

Biostatistics as a service model for the development of insights and reduction in clinical studies cost

Client Background

A global Fortune 500 research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need.

Client Need

The client experienced a substantial challenge for managing biostatistics needs, and an unpredictable requirement for statistical analysis expertise. The Client was looking for a partner in order to tackle the following challenges:
  • Deeper expertise in Biostatistics
  • Reducing cost of clinical operations
  • Difficulties in managing requirements and ensuring quick turnaround times due to unanticipated needs
  • Lack of adequate internal resourcing to meet demands

Our Solution

Innova Solutions developed a tailored solution to deliver a flexible and cost-efficient service that effectively met our client’s needs. This included:
  • Biostatistics as a service model that supported:
    • Smarter trial design
    • Group-sequential and adaptive trial design
    • Data Monitoring Committee (DMC) support
    • Observational research
    • Non-interventional studies
    • Biosimilars
  • Supported the asset development by applying statistical programming and data visualization
The service included submissions in all major regions, working together with key groups like Global Regulatory Affairs, Safety, Project and Data Management, and Medical Writing

Tools & Technologies

SAS, R Language, Python

Key Benefits

  • Development of insights with improved efficiency and accuracy by 20% to 25%
  • Reduction in clinical studies cost by 30% by better protocol design
  • Improved resilience of the team by providing managed service than resources
  • Better collaboration and effective communication with colocation of biotechnicians with client’s clinical team
Case Study KeyPoints

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