Services

Better Design.
Better Results.

Our top-tier statisticians empower sponsors with the most efficient pathways to drug 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 statistics 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.

We believe the future of biostatistics lies in the development of higher-level models based upon more innovative study designs, and we strive to find new ways to better describe relationships between subject groups that cannot be represented by standard methods.

The biostatistician plays a key role in the planning and preparation of any study. From helping to design a cost-effective, optimal study and providing the relevant statistical input on the study protocol to representation at regulatory meetings, our team is there to support you every step of the way.

SDC's statistical support services include:

• Power and Sample Size Calculations
• Protocol Input and Development
• Adaptive Trial Design & Statistical Modeling
• Client Representation at Regulatory Agency Meetings
• Randomization Schedule Preparation
• Statistical Analysis Plan Development
• Interim Analysis Planning
• Meta Analysis/Post Hoc Analysis
• Pharmacokinetic (PK) Analysis
• Integrated Summary of Safety, Integrated Summary of Efficacy (ISS/ISE)
• SAS Programming and Validation of Listings, Tables, and Figures Utilizing CDISC Standards
• Validation of Statistical Results through Independent Programming
• SAS-Derived Data Review and Interpretation Tools (i.e. Patient Profiles & P-Value Summaries)