Welcome to SEMELO Health Care Company, 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.

Comprehensive Biostatistical Services

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.

Flexible and High-Quality Solutions

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.

Our Expertise and Competitive Advantage

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 Services

Our comprehensive range of services includes:

• Protocol Development: Including sample size and power calculations.
• Randomization Schedules: Efficient and reliable randomization plans.
• SAP Development and Review: Detailed and accurate statistical analysis plans.
• Writing Statistical Sections of the Clinical Study Report (CSR) & Review: Crafting and reviewing detailed statistical sections.
• Statistical Tables, Figures, and Listings Development: Creating precise and comprehensive statistical representations.
• CDISC Implementation: SDTM and ADaM datasets, SDTM annotated CRF, define.xml files.
• Support for IDMC and DSMB: Assistance for data and safety monitoring boards.
• Development Safety Update Report (DSUR) Support: Comprehensive DSUR support.
• Integrated Summaries of Safety and Efficacy: Detailed integrated summaries.
• Pharmacokinetic (PK) and Pharmacodynamics (PD) Analysis: Expert PK/PD analysis.
• CRF Tabulations and Patient Profiles: Accurate CRF tabulations and patient profiles.
• Data Management Listings: Detailed data management listings.
• Edit Checks: Rigorous data edit checks.
• General SAS Dataset Remapping/Restructuring: Efficient dataset remapping and restructuring.
• Creating define.xml and Data Reviewer’s Guide Documents: Comprehensive documentation for SDTM and ADaM.
• Performing Consistency Checks Beyond Pinnacle 21: Advanced consistency checks for define.xml against aCRFs and databases.

Partner with SEMELO Health Care Company for unparalleled expertise, reliability, and efficiency in Biostatistics & Statistical Programming services. Unlock the full potential of your drug development program with our exceptional solutions and support.

SEMELO Health Care Company – where expertise meets excellence in Biostatistics & Statistical Programming.