Biostatisticians always play a crucial role in planning and preparation of any clinical trial study. Our biostatistics team supports every step of the process and provides full range of statistical services for clinical development planning, execution, and analysis throughout clinical trial phases.
Our Biostatistics Services include:
- Full service or independent biostatistical and programming support
- Support for preliminary meetings and represent on behalf of Client at Regulatory Agency Meetings
- Protocol and statistical analysis plan development
- Study Design & Endpoint Development
- Sample Size/ Power Calculations
- Randomization Schedule Preparation
- Statistical Analysis Plan Development
- Meta Analysis/Post Hoc Analysis
- Pharmacokinetic (PK) Analysis
- Interim analyses and co-ordination of Data Safety Monitoring Committee
- Preparation of integrated summaries of safety and efficacy for regulatory submissions
- Preparation and review of essential clinical study documents (Clinical Study Protocol, Clinical Investigation Plan, Statistical Analysis Plan, Clinical Study Report, Clinical Investigation Report)
- Preparation and validation of tables, listings and graphs.
- Review and Support for Publications