Certificate course in Clinical Research

Overview

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.

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or relieving disease symptoms. Clinical Research is conducted on human beings before we get marketing approval to ensure the safety and efficacy of the drug.

Why should you choose a career in Clinical Research?

• Demand is High for Clinical Research
• India is considered as a preferred hub for Clinical Trials, therefore there are good opportunities for career development

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
• CRO/SMO/Recruitment techniques/Retention of patients/Central lab, Local lab
• 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.

Eligibility

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

Minimum Education