SAS

SAS SAS 6.x 8.x 9.x SAS/BASE, SAS/STAT, SAS/SQL, SAS/MACROS, SAS/GRAPH, SAS/ACCESS, SAS/AF, SAS/CONNECT, SAS/QC, SAS/ETS, SAS/ODS, SAS/EG, SAS/ETL Studio, SAS/SPDS, SAS Enterprise Miner, SAS/Warehouse administrator
DOMAIN / RELATED
TECHNOLOGIES
Drug & Device release process from IND submission to FDA approval in compliance with 21CFR Part 11
Clinical Trials data - Demographic data, Discrepancy data, Adverse Events (AE), Serious Adverse Events (SAE), Laboratory data (Lab data), Physical and Vital Signs and Audit trials
Clinical Trials (Phases I-IV)
Preparation of IND, NDA, safety reviews, adverse event report reviews, integrated safety and efficacy summary (ISS & ISE) for FDA submission