High clinical trial attrition rates and increasing costs demand a smarter, more efficient approach to drug development.
Information that drives conclusive insights
It all starts with proper design and planning
We work with customers to determine the best methods for collecting, analyzing, and presenting data in keeping with regulatory requirements. From careful up-front planning to protocol design, from calculating sample size to writing and reviewing the clinical study report, we integrate biostatistics activities with the full project plan to deliver studies that are painstakingly designed and meticulously executed.
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Something just wasn’t right
While conducting a Phase 2/3 dose-finding/pivotal study for an adult growth hormone drug, the customer changed its protocol midstream in response to regulatory feedback and was rethinking other aspects of the trial, adding to its complexity.
Ethical considerations of adaptive design
The overall objectives of an adaptive design approach are to make clinical trials more efficient, more informative, or more likely to demonstrate an effect of the investigational product.