CR

CDM

SAS

Introduction & Drug Discovery,

Clinical Research Development,

Bioinformatics & Drug Development,

Roles, Responsibilities & Process,

Clinical Data Management Process,

ICH-GCP,

21CFR11,

Introduction to CDISC,

Regulatory Submissions,

Study Start up Process,

Essentials for Clinical Monitoring.

Introduction to data bases,

Data Management Plan,

Study Setup,

EDC(Electronic Data Capture),

CRF Design,

Pharmacovigillance,

Med DRA,

Regulatory Aspects in Pharmacovigillance,

Adverse Drug Reaction,

Management of ADR,

Periodic Safety Up date Reports,

EUDRAvigilance,

Open Clinica,(Comprehensive),

Oracle Clinical, Rave (Over view),

Pharmacovigillance,

Regulatory Affairs.