| 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 |
