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

• Clinical Research Introduction
• Principles of Pharmacology & Drug Discovery & Development
• Roles & Responsibilities of Key Stakeholders
• Preparations & Planning for Clinical Trials
• Essential Documentation in Clinical Research & Regulatory Submissions
• Clinical Trials Project Planning & Management
• Study Start up Process
• Clinical Monitoring Essentials
• Compliance, Auditing & Quality Control in Clinical Research
• Clinical Data Management, Biostatistics, Analysis & Report