PG Diploma in Clinical Research
About This Course
This program provides a comprehensive understanding of clinical research, data management, pharmacovigilance, medical writing, regulatory affairs, and biostatistics. It combines theory with hands-on projects to prepare you for real-world roles in the clinical research industry.COURSE HIGHLIGHTS 100% Placement Assurance. Outstanding Placement Track Record. Over 3000 students have been suc and...
Show moreWhat you'll learn
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Clinical trial processes & GCP guidelines
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Data management & EDC systems
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Pharmacovigilance & drug safety reporting
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Medical & scientific writing
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Regulatory submissions & compliance
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Basics of biostatistics for trials
Course Curriculum
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Week 1 – Introduction to Clinical Research & Management
read- Basics of clinical research & phases of trials
- Good Clinical Practices (GCP) & ICH guidelines
- Roles & responsibilities of stakeholders (CROs, sponsors, sites)
Week 2 – Clinical Data Management
read- Data collection methods & CRF design
- Clinical trial databases & EDC systems
- Data validation, cleaning, and quality checks
Week 3 – Pharmacovigilance
read- Introduction to drug safety & ADR reporting
- Signal detection & risk management
- Case processing & safety databases
Week 4 – Medical Writing
read- Fundamentals of medical & scientific writing
- Writing clinical study protocols & reports
- Publication ethics & regulatory documents
Week 5 – Pharma Regulatory Affairs
read- Regulatory bodies (FDA, EMA, CDSCO)
- IND, NDA, ANDA submissions
- Regulatory compliance & audits
Week 6 – Biostatistics & Final Project
read- Basics of biostatistics & trial design
- Statistical tools & interpretation of results
- Final project presentation + placement preparation
Prerequisites
M.B.B.S / B.D.S / B.A.M.S / B.H.M.S.
B. Pharmacy / M.Pharmacy / B.M.L.T
BSc in M.L.T / B.P.T / BSc in Nursing.
BSc and MSc in Biotechnology, Microbiology, Genetics
B.E (Biotechnology) / B.tech (Biotechnology).
Biochemistry ,Botany , Zoology ,Statistics or life sciences.
Course Includes:
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1 Topic
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6 Lessons
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6 Articles
