Biostatistics & SAS Programming

Our team comprises highly experienced Biostatisticians and Statistical Programmers dedicated to delivering Clinical Data in adherence to CDISC standards. With expertise across a wide range of therapeutic areas and all phases of clinical trials, we prioritize process optimization and accelerated timelines without compromising quality.

Our Biostatistics services include

• Providing statistical input for protocol and study design development
• Conducting sample size estimations
• Developing Statistical Analysis Plans (SAP)
• Reviewing clinical protocol development, Case Report Forms (CRFs), and Clinical Study Reports (CSRs)
• Planning and implementing final and interim study analyses
• Generating Integrated Summaries of Safety/Efficacy (ISS/ISE)
• Offering publication support and conducting ad-hoc analyses

Our Statistical services include

• SAS and R Programming: Generating SDTM/ADaM datasets, tables, listings, and figures
• CDISC implementation: Implementing SDTM and ADaM standards, creating Define.xml and annotated CRF
• Standardized SAS Macros: Developing optimized SAS macros for efficient code execution
• PK/PD Analysis: Performing pharmacokinetic/pharmacodynamic analysis
• Development of integrated ADaM datasets: Creating datasets for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
• Analysis for BA/BE Studies: Conducting statistical analysis for Bioavailability (BA) and Bioequivalence (BE) studies
• Meta Analysis: Performing meta-analyses of relevant data
• Support for Safety and Efficacy Monitoring — interim and exploratory analysis, manuscripts, abstracts
• Patient Profiles / Safety Narratives generation
• Statistical Report Writing and Submission — comprehensive statistical reports and submission support