Led by executive team with over 20 years sponsor-side experience we appreciate the pressures a pharmaceutical team faces to produce submission-ready data analysis under tight regulatory timelines.
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)