Welcome to CodeStat Solutions, your premier destination for expert Biostatistics & Statistical Programming services tailored to meet the diverse needs of the pharmaceutical industry across Clinical Trials phases I to IV and Real World Evidence and Outcome Research.

 

Our biostatistical services are integral components of clinical studies, offered either as part of a comprehensive clinical trial package, as stand-alone services, or as consulting solutions. With a proud history of delivering expert clinical trial statistical analyses and programming across various therapeutic areas, our team of biostatisticians and SAS® programmers has earned a reputation for excellence, responsiveness, collaboration, and scientific integrity.

 

When you choose to partner with us, you have the flexibility to be as hands-on or hands-off as you prefer. Whether you provide us with the study protocol, SAP, data, and CRFs, or detailed specifications for in-house validation, our skilled team is equipped to deliver validated outputs of the highest quality, accuracy, and timeliness.

Biostatistics is the cornerstone of clinical trials, and selecting the right statistical advisor is paramount. With our extensive operational experience in the field, we offer a competitive advantage for your drug development program. Our biostatisticians possess experiential knowledge of statistical methodology and its applications to clinical trials and drug development, ensuring the adoption of the most valid and powerful statistical analysis methods to maximize the technical success of your program.

 

Our comprehensive range of services includes:

 

• Protocol development, including sample size and power calculations
• Randomization schedules
• SAP Development and Review
• Writing statistical sections of the clinical study report (CSR) & Review
• Statistical Tables, Figures, and Listings development
• CDISC Implementation (SDTM and ADaM Datasets, SDTM Annotated CRF, define.xml Files)
• Support for IDMC and Support of data and safety monitoring boards (DSMB)
• Development Safety Update Report (DSUR) support
• Integrated summaries of safety and efficacy
• Pharmacokinetic (PK) and Pharmacodynamics (PD) analysis
• CRF Tabulations and Patient Profiles
• Data Management Listings
• Edit Checks
• General SAS Dataset Remapping/Restructuring
• Creating define.xml and data reviewer’s guide documents for both SDTM and ADaM
• Performing consistency checks beyond Pinnacle 21 validation checks for define.xml against aCRFs and databases

Partner with CodeStat Solutions for unparalleled expertise, reliability, and efficiency in Biostatistics & Statistical Programming services, and unlock the full potential of your drug development program.