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B.Sc. (Hons.) Clinical Research - Clinical Trial Operations and Management
Program Details
The B.Sc. (Hons.) in Clinical Research is an undergraduate, industry-oriented program that equips students with knowledge and practical skills in the scientific, regulatory and operational aspects of clinical research. This program integrates theory with hands-on training in clinical trials, regulatory affairs, pharmacokinetics and research operations aligned with national and international standards (ICH-GCP, WHO, CDSCO).
The Clinical Trial Operations and Management specialisation focuses on planning, monitoring, execution and management of clinical trials in accordance with ethical and regulatory standards. It provides students practical exposure to documentation, quality assurance, site management and project coordination in alignment with ICH-GCP and global regulatory requirements.
Program Highlights
- Industry-aligned curriculum with strong focus on ICH-GCP and regulatory compliance
- Practical exposure to clinical trial documentation, protocols and pharmacokinetic datasets
- Skill-based learning through case studies, simulations, practical exercises and internships
- Training across pharmacokinetics, biostatistics, research ethics and clinical trial operations
- Guest lectures, expert sessions and workshops led by industry professionals
- Strong emphasis on employability, regulatory readiness and ethical conduct
Industry Trends and Career Opportunities
India’s clinical research ecosystem is expanding rapidly, supported by cost advantages, evolving regulations and increasing trial activity. Employers are seeking graduates who can work confidently with pharmacokinetics, biostatistics and data-driven clinical decision-making, with growth in roles linked to clinical data and analytics. The expansion of global CROs, pharma, biotech and vaccine research organisations is also widening entry pathways. Key trends shaping opportunities include AI-enabled analytics, real-world evidence (RWE), and decentralised clinical trial models, alongside sustained demand for clinical operations and compliance talent.
Typical pathways include:
- Clinical Research Coordinator (CRC) / Clinical Trial Assistant (CTA)
- Pharmacokinetics Analyst (entry level)
- Clinical Data Associate
- Regulatory Affairs Executive
- Medical Writing Associate
- Pharmacovigilance Associate
- Project Coordinator – Clinical Research
- Research Assistant (hospitals, CROs, academia)
Placements
The program supports placement readiness through strong industry engagement and practical training, with opportunities linked to pharmaceutical companies, CROs, hospitals, research institutions and relevant bodies. The placement cell supports internships, industry interactions, career guidance and skill-building, helping graduates move into roles across clinical trials, pharmacokinetics, regulatory affairs and clinical research operations in India and globally.
Fee Structure
Click here for detailed Fee Structure.
Eligibility
Interested candidates must meet the following minimum eligibility criteria for admission to the B.Sc. (Hons.) Clinical Research program: A minimum of 50% aggregate marks in Class X and XII, with Physics, Chemistry, and Biology (PCB) and English as a compulsory subject at the 10+2 level.
Selection Criteria
The selection of candidates for admission to the B.Sc. (Hons.) Clinical Research program at UPES is based on the candidate’s performance in the Personal Interview, in accordance with university admission guidelines.
Curriculum
Semester 1
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Human Anatomy & Physiology | 2 | 1 | 1 | 4 |
| General Chemistry | 1 | 1 | 1 | 3 |
| Physics for Life Sciences | 1 | 1 | 0 | 2 |
| Basic Mathematics | 1 | 1 | 0 | 2 |
| Introduction to IT Systems for Health Sciences | 1 | 1 | 1 | 3 |
| Fundamental of Clinical Research | 2 | 1 | 1 | 4 |
| Fundamentals of Biostatistics | 3 | 1 | ||
| Managing Self | 2 | 0 | 0 | 2 |
| Environment Sustainability & Climate Change | 2 | 0 | 0 | 2 |
Semester 2
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Principles of Biochemistry | 1 | 1 | 1 | 3 |
| Community Health and Disease | 1 | 1 | 1 | 3 |
| Biosafety and Aseptic Techniques | 1 | 1 | 1 | 3 |
| Pathophysiological Basis of Human Diseases | 2 | 1 | 0 | 3 |
| Time & Priority Management | 2 | 0 | 0 | 2 |
| Environment Sustainability & Climate Change (Living Lab) | 2 | 0 | 0 | 2 |
| Technologies of the Future | 2 | 0 | 0 | 2 |
Semester 3
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Clinical Sampling and Analytical Techniques | 1 | 1 | 1 | 3 |
| Pharmacology and Toxicology | 2 | 1 | 1 | 4 |
| Bioethics and Drug Safety | 1 | 1 | 0 | 2 |
| Design and Management of Clinical Trials | 1 | 1 | 1 | 3 |
| Data Management | 3 | |||
| EDGE-Soft Skills | 1 | |||
| Communication Skills (Oral) | 2 | |||
| Program Electives - I (Specialisation) | 2 | 1 | 0 | 3 |
| Exploratory I | 3 | 0 | 0 | 3 |
| Project Internship (Srijan) | 1 |
Semester 4
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Clinical Trial Monitoring | 2 | 1 | 1 | 4 |
| Bioinstrumentation | 1 | 1 | 1 | 3 |
| Communication Skills (Written) | 2 | |||
| Program Electives - II (Specialisation) | 2 | 1 | 0 | 3 |
| Exploratory II | 3 | 0 | 0 | 3 |
Semester 5
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Pharmacovigilance | 2 | 1 | 1 | 4 |
| Immunology | 1 | 1 | 1 | 3 |
| Epidemiology and Global Health | 2 | 1 | 0 | 3 |
| Data Visualisation | 3 | |||
| Working with People | 0 | 0 | 0 | 2 |
| Program Electives - III (Specialisation) | 2 | 1 | 0 | 3 |
| Exploratory III | 3 | 0 | 0 | 3 |
| Summer Internship (Samarth) | 1 | |||
| Exploratory IV | 3 | 0 | 0 | 3 |
Semester 6
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Biopharmaceutics | 2 | 1 | 1 | 4 |
| Pharmacotherapeutics | 2 | 1 | 1 | 4 |
| Global Regulations in Clinical Trials | 1 | 1 | 0 | 2 |
| Deepening Self | 2 | |||
| Program Electives - IV (Specialisation) | 2 | 1 | 0 | 3 |
| Exploratory V | 3 | 0 | 0 | 3 |
| Exploratory VI | 3 | 0 | 0 | 3 |
Semester 7
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Research Methodology | 2 | 1 | 0 | 3 |
| Emerging Technologies in Clinical Trials | 3 | 1 | 0 | 4 |
| Health Economics and Outcome Research | 3 | 1 | 0 | 4 |
| Data Science and Machine Learning | 3 | 3 | ||
| Exploratory VII | 3 | 0 | 0 | 3 |
| Program Electives - V (Specialisation) (Capstone) | 0 | 0 | 4 | 4 |
| Indian Knowledge System | 3 | 3 | ||
| Industrial Internship | 1 |
Semester 8
| Course | L | T | P | Credit |
|---|---|---|---|---|
| Company Placement / Research Project | 12 | |||
| Exploratory VIII | 3 | 0 | 0 | 3 |
| TOTAL | 40 |
*Students not opting for exploratory minor and taking exploratory Courses from different baskets have to complete minimum 18 credits.
*Students opting for minor have to take exploratory courses from same basket to complete minimum 24 credits and earn minor. (for 3-year degree as well.)
Specialisation Tracks: Clinical Trial Operations and Management
| Program Elective | Course Name | Semester | Credits |
|---|---|---|---|
| Program Elective I | Clinical Trial Operations and Site Management | III | 3 |
| Program Elective II | Predictive Clinical Trial Design and Digital Innovations | IV | 3 |
| Program Elective III | Pharmaceutical Quality Systems and Compliance | V | 3 |
Minors
To opt the minors, please choose the minors from the bucket. Click here to know more.
