PHARMA DATA ASSOCIATES

We are a team of statisticians, SAS programmers, and clinical data managers who previously worked in the large and small biopharmaceutical companies or government agencies (including the FDA and NIH Clinical Center)... Individually or as a team, we provided a full range support to the clinical development. We supported protocol development, designed Case Report Forms (CRFs), wrote Statistical Analysis Plans (SAPs) and Data Management Plans (DMPs), cleaned and locked clinical trial databases, programmed in SAS for tables/listings/figures (TLFs), conducted ad hoc analyses, reviewed or coauthored Clinical Study Reports (CSRs). We successfully prepared the statistics data packages in the FDA eSubmission-compliant format for New Drug Applications (NDAs), supported the preparation of the FDA briefing books, and prepared Q/As for the FDA Advisory Committee (FDAAC) meetings... Prior to forming Pharma Data Associates (PDA), we worked in biopharmaceutical companies at the management level and..

Also known as: Pharma Data Associates, LLC

Primary location: Piscataway United States