- 21 CFR Part 11
- Global Regulatory Guidelines
Our team of biostatistician and statistical programmers provide a full range of biostatistical services including sample size calculations, randomization schedule generation, blinding and unblinding procedures, statistical analysis plans and statistical analyses.
- Clinical Trial Study Design
- Study Sample Size Calculations and Randomization.
- Statistical Inputs to Clinical Study Protocol Development
- Statistical Analysis Plan (SAP) Development and Interpretation
- Statistical Reports
- SAS Programming as per CDISC (SDTM/ADaM) Standards
- Performance of Statistical Analysis
- Generation of Tables/Listings/Graphs (TLGs) and Validation
- Generation of Tables/Listings/Figures (TLFs) and Validation
- Performance of interim Statistical Analysis
- Stand-alone Statistical Reports
- Clinical Statistical and Study Reports Writing
- SAS Datasets Creation as per CDISC
- Program Validation
- Integration of Databases Across Protocols
- Integrated Summaries of Safety and Efficacy (ISS & ISE) for Regulatory Submissions.
- Summary of Clinical Safety and Efficacy (SCS & SCE) for Regulatory Submissions.
- Data derivation and mapping to CDISC standards
- Implementation of CDISC SDTM and ADaM standards