Cliniminds Kolkata

This is a comprehensive educational program, designed for the Pharma /Medical/Life Sciences professional aspiring to work in the field of clinical research or allied professions like central labs, CROs, Sponsor Company. The program provides complete overview and practical environment in the field of clinical research. The program would help candidates to upgrade their knowledge about ICH GCP Guidelines, regulatory issues and other major aspects of clinical trials management. Program would help in developing career in the field of clinical research. In the second part of the program we would cover the Clinical Data Management in detail. We have divided the course in two parts. In First part, we cover aspects of Clinical Research. In the second part, we cover basic and core CDM knowledge like data validation and data development etc

Course Details

Highlights

• Introduction to Clinical Research & Phases in Clinical Research
• Principles of Good Clinical Practices - ICH GCP
• Ethical Considerations in Clinical Trials
• Regulations in Clinical Research
• Sponsor/Investigator Responsibilities
• Investigator Responsibilities
• Clinical Trial Design
• Protocol Design
• CRF Design
• Essential Documents in Clinical Research
• IND Application
• Clinical Study Report
• NDA Submission
•  Informed Consent Process & Documentation
• Site Selection