Data Management and Biostatistics
Our Data Management and Biostatistics Department along with IT and programming consultants provide you with the expert services needed, in compliance with ICH GCP Guidelines, 21 CFR Part 11 requirements as well as your specific needs. Statistician’s role is not only to advise on study design, sample size, and power of your study but also to make recommendations during the study based on interim analyses to ensure you do not waste resources in case desired results, i.e. study hypothesis or endpoints, cannot be obtained.
Our services include:
- Statistical Analysis Plan (SAP)
- Database programming and validation
- Management of incoming data
- Manual DCFs for data-checks that cannot be programmed
- Data reconciliation, database cleaning and lock
- Statistical analysis, interpretation and reporting (both interim and final)
- Data entry in case paper CRFs are used
