Clinical research

The field of Clinical Research is vital for the development of new treatments and medical advancements. Our 3-year Clinical Research program at Viast is designed to provide a comprehensive understanding of the clinical trials process, from study design to regulatory compliance. Students will gain in-depth knowledge of ethical considerations, data management, and the intricacies of conducting clinical trials. The curriculum is enriched with practical training and internships, enabling students to experience real-world clinical research environments.

Duration: 3 years

Eligibility: 10+2 with Science stream

Career Prospects: Clinical Research Coordinator, Clinical Trial Manager, Data Manager, Regulatory Affairs Specialist, Clinical Research Associate, Medical Writer.

Course Structure:

Introduction to Clinical Research:

•    Fundamentals of clinical research
•    Phases of clinical trials
•    Historical context and evolution of clinical research

Clinical Trial Design and Management:

•    Protocol development and study design
•    Patient recruitment and informed consent process
•    Clinical trial operations and site management

Ethical and Regulatory Considerations:

•    Good Clinical Practice (GCP) guidelines
•    Institutional Review Boards (IRBs) and ethics committees
•    Regulatory requirements (FDA, EMA, ICH)

Data Management and Biostatistics:

•    Data collection, entry, and validation
•    Statistical methods and data analysis
•    Managing clinical trial databases

Pharmacovigilance and Safety Reporting:

•    Monitoring adverse events
•    Safety reporting procedures
•    Risk management in clinical trials

Project Management in Clinical Research:

•    Project planning and budgeting
•    Quality assurance and control
•    Managing clinical research teams

Practical Training and Industry Exposure:

•    Internships with clinical research organizations and pharmaceutical companies
•    Hands-on training with clinical trial management software
•    Case studies and real-world projects

Capstone Project:

•    Independent research project in clinical research
•    Collaboration with industry mentors
•    Presentation and defense of research findings