Biostatistics and 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) analyses.
- 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: Providing statistical support for safety and efficacy monitoring, interim and exploratory analysis, and the development of manuscripts and abstracts.
- Patient Profiles/Safety Narratives: Generating patient profiles and safety narratives.
- Statistical Report Writing and Submission: Writing comprehensive statistical reports and assisting with submission requirements.
