Certificate course in Clinical Research

Applicant should have done Mpharm / PharmD / MSc Microbiology and English Communication must be fluent.

The Duration of the course will be 3 months and fee will be 30,000 INR + GST (can pay in installments also [17700 + 17700] but this option is only available for offline students). Also the course will be available on both Online and Offline Mode.

Modules:

The program is designed by industry experts for students and young professionals. The training provides in-depth knowledge of Clinical Research including a theoretical aspect of the field and on site practical training.

• History of Clinical Research and Good Clinical Practice (ICH E6R2)
• New Drug and Clinical Trial Rules and Good Documentation Practice (GDP)
• Workflow of BE Study (Healthy volunteer) and patient based Clinical trial
• Clinical trial study design, Protocol, and Essential documents list
• AE/SAE Reporting and Overview of Protocol and Amendments
• Orientation on various regulatory Guidelines (e.g. DCGI, EMA, USFDA, NPRA, MHRA, etc.)
• Source Data Review & Verification Practical/Simulation
• Sites discrepancy management, EDC, IVRS, IWRS
• Monitoring and Safety Reporting, Monitoring Visit Reports Monitoring Informed Consent documents and procedure
• Regulatory Compliance and Quality Assurance: Audits and Inspections

Additional Benefits:

• Personality development, public speaking and communication workshops
• Email Etiquette and skill development program
• Use of social media for career development
• Interview Preparation

Career Prospects with Placement Assistance:

Placement Assistance will be provided for 3 months after the completion of course and placement will be provided for PAN India.