Our experienced biostatistics team will take ownership of your needs.
Our top-tier biostatistics team provides full support to our clients by helping to determine the most efficient pathways to product approval. Our team of experts has an in-depth understanding of a number of key therapeutic areas, including a deep knowledge of the evaluation histories of similar studies and the distinct statistical issues that affect therapeutic pathways.
The biostatistics team at SDC is committed to providing the very latest in statistical thinking. To accomplish this goal, we stay abreast of the latest statistical methods and related regulatory preferences. Our statisticians are experienced in interacting with the FDA and other regulatory agencies and pride themselves on the ability to effectively communicate on behalf of our clients.
- Protocol Development
- Sample Size Calculations
- Client Representation at Regulatory Agency Meetings
- Randomization Schedule Preparation
- Statistical Analysis Plan (SAP) Development
- SAS Programming and Independent Validation of Tables, Listings, and Figures
- Interim Analysis Planning
- Topline Analysis Package (delivery within 3 business days of database lock)
- Final Analysis Package (delivery within 10 business days of database lock)
- DMC Statistics Services
- PK/PD Analysis
- Integrated Summaries of Safety and Efficacy (ISS/ISE)
- Statistical Reports
- Statistical Review of Clinical Study Reports (CSR)
- Submission-Ready Services (SDTM, ADaM)