Our Capabilities and Recent Accomplishments

Biostatistics Support for Clinical Studies

Standardization and Compliance to the FDA eSubmission Requirement

Preparation of the Statistics Package in the FDA eSubmission-ready format

Data Management Support

PDA's Recent Accomplishments

3 NDA successfully filed

3 Phase 3 studies and 5 Phase 2 studies

Protocol development

Passed the client’s pre-Phase 3 and Post NDA biostatistics audits