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 FB2D provides you support in evolving areas of efficient study designs and complex statistical analysis methods:
- Study design
- Endpoints development
- Sample size calculations
- Randomization
- Interim analysis planning
- Protocol writing
- Statistical Analysis
- Statistical Analysis Plan (SAP)
- Definitions of derived datasets as per Client’s SOPs and regulatory requirements
- Validation of SAS outputs for Tables, Figures and Listings used in Clinical Study Reports (CSR), as per ICH E3
- Liaison with Data Safety Monitoring Boards, Clinical Events Committees (charters, blinded and non-blinded meeting reports)
- Interpretation and Reporting
- Statistical Report writing
- Clinical Study Report (CSR)
- Integrated Safety and Efficacy summaries (ISS, ISE)
- Safety reports
- Protocol writing
- Quality Control
Complete and accurate statistical documentation align the expectations of client and regulatory agency.
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