Clinical Services Biostatistics

Biostatistics

CTI Biostatisticians are involved in the entire lifecycle of drug development from regulatory pathway design through medical writing. Our Biostatisticians interact on a daily basis with our teams in project managers, clinical monitors, data management, safety, regulatory, and medical affairs. These interactions ensure that data are captured appropriately and consistently across all investigative centers. These interactions also ensure statistical questions that arise are answered in a timely manner, and statistical analyses performed and inferences made are clinically relevant. Our Biostatistics team is flexible, with fast turn-around times on ad hoc analysis and data transfer requests, in addition to having the ability to work with a variety of files types.

Dave McCollum, MS
Director, Biostatistics
With nearly 25 years of academic and industry experience in biostatistics, Dave has vast knowledge of biostatistics and experience with various types of clinical trials and therapeutic areas allow him to serve as a great asset to our team and to our sponsors.

Dave Mccullum

Specific services include the following:
• Protocol development
• Case report form (CRF) and electronic case report form (eCRF) review
• Statistical analysis plan (SAP) development
• Statistical programming
• Randomization
• Statistical reports
• Data and Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC) participation

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