About the Program
The Clinical Research program is designed to provide a comprehensive understanding of the clinical research process, including clinical trials, bioequivalence studies, regulatory guidelines, and patient safety protocols. By the end of the program, you’ll be able to plan, conduct, and manage clinical research projects with confidence.
What You’ll Learn
- Introduction to Clinical Research and its importance in healthcare
- Pre-clinical studies and regulatory guidelines
- Bioequivalence (BE) studies and clinical trial phases
- Clinical study reports (CSR) and documentation standards
- Patient safety, ethics, and compliance in clinical trials
- Data collection, analysis, and interpretation in clinical research
- Real-time case studies and practical applications
Why Choose This Course?
- Learn from industry professionals with real-world clinical trial experience
- Hands-on exposure to clinical research protocols and documentation
- Comprehensive coverage of all clinical research phases
- Placement guidance and career support in healthcare and pharma sectors
- YVU–SkillDzire recognized certification
Who Can Join?
Ideal for students, healthcare professionals, pharma aspirants, and anyone interested in a career in Clinical Research, Regulatory Affairs, or Pharmaceutical Studies.
Course Curriculum
1. Introduction to Clinical Research
- Overview of Clinical Research
- Guidelines for Clinical Trials
- Pre-clinical Studies
2. Bioequivalence (BE) Studies
- Introduction to BE Studies
- BE Clinical Phase
- Analytical Phase in BE Studies
- BE Clinical Study Report (CSR)
- Bioequivalence & Bioavailability
- Bioequivalence Case Study: Metformin IR
- Bioequivalence Study of Olmesartan
- Topical Product Bioequivalence
3. Clinical Trial Phases
- Phase 1 Clinical Trials
- Phase II, III, & IV Clinical Trials
- Phase III IR
- Phase 3 Rosuvastatin + Ezetimibe
4. Special Topics in Clinical Research
- Clinical Pharmacology
- Hypertension and its Clinical Trials
- Letrozole: A Case Study
- Olmesartan IR: Clinical Study Overview
5. Real-Time Tasks
- MetaforminIR_04
- Olmesartan IR_11
- Letrozole IR_18
- Phase 1 - Topical Product
- Phase III (Efficacy & Safety) Study of Rosuvastatin/Ezetimibe Tablets (FDC) in Hypercholesterolemia Volunteers
Earn Your Certificate
On completion, you’ll receive an industry-recognized certificate from YVU – SkillDzire.
Real-Time Clinical Research Projects
Bioequivalence (BE) Study Report
Hands-on project to analyze and prepare a BE clinical study report, including study design, data analysis, and regulatory documentation.
Clinical Trial Documentation
Create and manage essential clinical trial documents such as protocol, informed consent forms, case report forms, and study logs for Phase I-IV trials.
Data Analysis & Regulatory Submission
Perform statistical analysis of trial data and prepare reports for regulatory submissions to agencies like FDA or CDSCO, following GCP guidelines.
Career Outcomes
Clinical Research Associate (CRA)
Salary Range: ₹3–6 LPA
Clinical Data Manager
Salary Range: ₹4–7 LPA
Regulatory Affairs Specialist
Salary Range: ₹5–10 LPA
What Our Students Say
“The Clinical Research program helped me understand clinical trials and bioequivalence studies thoroughly. I gained hands-on experience in data management and trial documentation, which helped me secure a role as a Clinical Research Associate.”
– Priya, PharmaCorp
“Working on real-time clinical study tasks made the learning experience very practical. I now work as a Regulatory Affairs Specialist and feel confident handling compliance and documentation for clinical trials.”