Biostatistics
Biostatistics is a necessity for clinical trials, and making sure you choose the right statistical advisor is imperative. Our extensive operational experience in this field provides a competitive advantage for your drug development program.
Protocols and statistical analysis plans are the most important documents in your drug development program. The Pharmapace statistical team has experiential knowledge about statistical methodology and their applications to clinical trials and drug development. Our biostatisticians use the most valid and powerful statistical analysis methods to maximize the probability of technical success of your program.
Keys to Successful Biostatistics:
- Statistical strategy for clinical development, regulatory submissions and interactions
- Design of pre-clinical and phase I, II, III, IV clinical trials
- Protocol development and sample size calculation
- Adaptive Designs, including stoppage rules and sample size re-estimation
- Prospective observational and case-control study designs
- Randomization scheme design and code generation
- Statistical analysis plans
- Support of clinical study conduct to help resolve ongoing issues
- Conduct statistical analysesWrite statistical sections of clinical study reports
- Expertise in meta-analysis, predictive analytics, statistical modeling and simulation
- Plan the integrated summaries of safety/efficacy (ISS/ISEs) for Common Technical Documents (CTDs)
- Represent sponsors in regulatory interactions, including FDA advisory committee meetings
- Independent unblinded statisticians for Data Monitoring Committee (DMC) and interim statistical analyses
- Due diligence assessments and gap analyses
- Assist sponsors in interactions with potential development partners
- Data mining for drug life cycle development
- Stability and potency data analyses for Chemistry, Manufacturing, and Controls (CMC)