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
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
Supported the asset development by applying statistical programming and data visualization
Data Monitoring Committee (DMC) support
Observational research
Non-interventional studies
Biosimilars
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
Realized 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
Tools & Technologies
SAS
R Language
Python
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