Services > Biostatistics & Biometrics

Capabilities

• Statistical inputs to protocol - Sample size estimation, design and analysis plan
• CRF review
• Statistical Analysis Plan (SAP) - Preparation in globally acceptable format
• Randomisation - Block, stratified, blinded and/or depending upon study design
• Tables, Listings and Graphs (TLGs)
• Statistical analysis - For Pre-clinical, Bioequivalence and Clinical Trials (Phase I, II and III) based on pre-defined objective and hypothesis
• Supportive analysis - Interim, Post-hoc and Exploratory analyses

Experience

• More than 10 years in BA/BE projects and greater than 5 years experience in clinical trials and safety reporting
• More than 200 BA/BE projects, 4 patients based PK studies and 3 clinical trials per year

Services

• Statistical design and analysis of bioavailability and bioequivalence and Phase I - IV clinical trials

Our strength

• Qualified, trained and experienced team of statisticians and SAS programmers and data presentation in CDISC format
• Endowed with validated and licensed software WinNonlin 5.0.1 for Pharmacokinetic-Pharmacodynamic (PK-PD) modeling and SAS 9.1 (Base, Stat, Graph, Assist, Access [Oracle]) for statistical analysis and safety reporting
• High quality data presentation and statistical report writing in accordance with global regulatory standards with sophisticated planning and execution
• Extensive experience in handling and performing Toxicokinetic/PK-PD analysis
• Systematic and documented implementation of validation and QC procedures