The course covers all the basic areas of Clinical research and Clinical Data management. Successful completion of the 6 months Diploma helps candidates to apply for entry level jobs in both Clinical Research and Clinical Data Management
· Introduction to clinical Research
· Clinical Research process
· Introduction to drug discovery and development
· Bioinformatics and drug development (PK, PD)
· GCP guidelines
· Regulatory authorities involved in clinical research
· Roles and responsibilities of investigator and study team
· Essential documentation in clinical research
· Regulatory submission
· Clinical trial requirement in India
· Regulatory environment in USA, Australia, Europe and India
· Schedule Y
· Adverse drug reactions and its management
· Serious adverse events (SAE)
Clinical Data Management:
· Clinical Data Management plan
· Data management process
· CRF design
· 21 CFR Part 11
· Introduction to CDISC
· Open clinica
· Oracle clinical
· SAS Enterprises Guide
· Over view of SAS
Eligibility: Any life science degree.
Course Duration: 6 months
Live online classes also available.
Suitable for students, professionals, freshers, and those seeking a career change.
Batch starts on 14/5/11!
Enroll now for a lucrative career in the field of clinical research and clinical data management.
ALDOS MEDSERVE 628/2 11th cross, Indira Nagar 1st stage, Near Indira Nagar police station, Bangalore -38