Biostatistics

Prologue’s biostatisticians and statistical programmers have all earned advanced academic degrees and have spent multiple years working in the pharmaceutical industry. All staff members are cancer clinical trial specialists, both from an industry and CRO perspective. Our breadth of experience and exposure to multiple treatment paradigms translates into a team that is among the industry’s best. Our biostatisticians are frequently invited as speakers to key industry meetings, underlying our expertise in the evolving areas of efficient study designs and complex analysis methods.

Our core services include the following:

Study Design

• Patient sampling plans, endpoint development, trial size and duration
• Selection of the best design among competing alternatives (e.g., frequentist versus Bayesian, fixed sample versus adaptive)
• Particular expertise in adaptive study design
• Interim analysis planning with selection of efficient stopping rules for efficacy and futility
• Randomization, including traditional and dynamic allocation schemes

- click here to read an interview with Phil Banks, our resident expert on statistical
study design with a particular emphasis on adaptive techniques -

Statistical Analysis

• Statistical Analysis Plans, including mock production of Table, Listing and Figure displays
• Detailed documentation translating the Analysis Plan into a responsive and accurate programming effort
• Generation of analysis datasets using industry standard format conventions
• Application of simple and complex statistical models (e.g., competing risk models for time-to-event endpoints)
• SAS® production of Table, Listing and Figure displays for use in clinical study reports or other summary activities
• Provision of final documentation allowing the sponsor to replicate the output

Data Interpretation and Reporting

• Interim analyses, including coordination with Data Safety Monitoring Boards
• Stand alone statistical reports
• Interpretation, writing, and review of final clinical reports
• Ad hoc analysis
• Data mining

Regulatory Activities

• FDA/EMEA representation for all phases of clinical development
• Production of integrated summaries of efficacy and safety to support product licensure

Strict adherence to a comprehensive set of quality oriented Standard Operating Procedures facilitates the delivery of accurate and complete statistical products to our sponsors. Based on these quality processes, our production times and review cycles are highly efficient. Combination of a strong attention to quality and relevant experience in the cancer setting means that our biostatistics team is a prime choice for all your analytical needs.