Statistical Analysis & Biostatistics Services
Genelife Clinical Research boasts a Statistical Analysis department that excels in every aspect of statistical planning, execution, and reporting. With seasoned biostatisticians at the helm, Genelife ensures the robustness of clinical trial data for clients worldwide using our CRO in India.
Biostatistics Expertise
Our biostatisticians are proficient in the principles of the International Council for Harmonisation (ICH) E9 guidelines. Statistical services encompass the full spectrum — from SAP inception to delivery of final analysis reports and regulatory submissions.
Centralized Randomization System
Genelife has devised a state-of-the-art computerized central randomization system — fully validated and compliant with 21 CFR Part 11 standards. This system guarantees rapid, secure 24/7 online access to randomization procedures for investigators globally.
Statistical Services
- Statistical Analysis Plan (SAP) Development and Review
- Study Design and Sample Size Calculations
- Randomization and Blinding Procedures (central randomization system)
- Interim Analysis and Data Monitoring Committee (DMC) Support
- ANOVA, ANCOVA, Mixed Models, Survival Analysis, Cox Regression
- Pharmacokinetic & Pharmacodynamic (PK/PD) Analyses
- Integrated Summary of Safety and Efficacy (ISS/ISE)
- SAS and R statistical programming for all regulatory deliverables
- Tables, Listings, and Figures (TLF) generation
ICH E9 Compliance: All statistical analyses at Genelife are conducted in accordance with ICH E9 guidelines, ensuring regulatory acceptability of statistical methodologies for global submissions by our CRO in India.