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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 |
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DOMAIN / RELATED TECHNOLOGIES - Drug & Device release process
from IND submission to FDA approval in compliance with 21CFR Part 11 |
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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 |
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Clinical Trials (Phases I-IV) |
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Preparation of IND, NDA, safety reviews, adverse event report reviews, integrated
safety and efficacy summary (ISS & ISE) for FDA submission |
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