Biostatistics

Planning Services

Statistical considerations are an important part of adaptive designs. Our statistical group has more experience at the design and regulatory discussions regarding incorporation of adaptive aspects than anybody else in this industry, as a result of both our advanced technology that has allowed us to conduct adaptive studies for more than five years and a hundred studies. Our group is experienced with the tradeoffs, often subtle and complex, between adaptive designs, execution, and regulatory needs and can work with you to formulate a strategy that optimizes resources and timelines.

In addition, our statisticians are skilled at the more routine aspects of study design, conduction, and reporting, including:

Collaborating with the project team, our biometricians guide protocol development while concentrating on:

• Study protocol design;
• Definition of study endpoints;
• Sample size determinations;
• Statistical methodology specifications;
• Randomization plans.

Ensuring consistency with the analysis objectives, the biometricians work with the clinical team to develop:

• Contents of the CRF;
• Specifications for data validation.

With an eye toward the Clinical Study Report and maintaining compliance with ICH guidelines for statistical principles, our biometricians develop:

• Plans for comprehensive statistical analysis;
• Shells and/or specifications for all planned tables, figures, and lists.