Biostatistics

Founded by a statistician, Biostatistics is a fundamental service we offer our sponsors. We provide innovative trial designs informed by statisticians and statistical programmers with years of industry experience and therapeutic knowledge. Our Biostatistics team identifies the best method of analysis for each individual protocol, determining efficient and accurate pathways to positive trial results leading to product approval. With our parallel processing method, statistical analysis is completed within 24-48 hours after database lock.

Our statistics team has conducted hundreds of trial analyses for many different drug, medical device, and diagnostic products. We have created hundreds of statistical analysis plans and protocols. We began creating adaptive trial designs before the FDA published its guidance on this approach, and we use adaptive designs as often as possible.

Services include:

• Study sample size calculation
• Statistical programming
• Statistics section of a protocol
• Endpoint selection assistance
• Adaptive study design
• Statistical analysis plan (SAP) development
• Randomization
• Statistical simulations of clinical trials
• Statistical analyses and presentation to DSMC
• Analyses and statistical report writing
• Interim and exploratory analyses
• Integrated Summaries of Safety and Efficacy (ISS/ISE)
• Data integration and standardization (SDTM and ADaM)
• Statistical analyses presentation and defense before FDA
• Statistical consulting