Drug Development and Clinical Research
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What you'll learn
Explain the drug development process, clinical trial phases, and regulatory requirements in research.
Apply ICH-GCP, ethical guidelines, and clinical documentation standards in trial settings.
Analyze clinical research operations, pharmacovigilance, and compliance practices in the industry.
Details to know
June 2026
28 assignments
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There are 7 modules in this course
Master Clinical Research, Drug Development, and ICH-GCP with real-world insights.
Build industry-ready skills to launch your career in clinical trials and pharma. This comprehensive Clinical Research Training course is designed to help learners understand the complete lifecycle of drug development—from discovery to post-marketing surveillance. You will explore clinical trial phases, regulatory frameworks such as ICH-GCP and Schedule Y, and essential concepts like informed consent, pharmacovigilance, and bioequivalence studies. The course emphasizes practical, industry-relevant skills including SOP writing, clinical documentation, outsourcing processes, and communication in research environments. Through structured modules, learners will gain the ability to analyze clinical trial designs, understand ethical guidelines, and apply regulatory standards in real-world scenarios. Whether you are a student, graduate, or professional looking to enter the pharmaceutical or clinical research industry, this course equips you with the knowledge and confidence needed to succeed in roles such as Clinical Research Associate (CRA), Clinical Trial Coordinator (CTC), and Pharmacovigilance Associate.
Understand the fundamentals of drug discovery, development stages, and regulatory frameworks shaping modern clinical research.
What's included
9 videos4 assignments
9 videos•Total 61 minutes
- New Drug Discovery•4 minutes
- Clinical Trial Therapy•3 minutes
- Food,Drug & Cosmetic Act•5 minutes
- Thalidomide tragedy•8 minutes
- Approaches to Drug Discovery•7 minutes
- Drug Development Stages•11 minutes
- Intro ICF•11 minutes
- ICF History Overview•5 minutes
- ICF Evolution & Key Milestones•7 minutes
4 assignments•Total 60 minutes
- Drug Discovery & Regulatory Foundations•30 minutes
- Introduction to Drug Development•10 minutes
- Historical Insights & Development Process•10 minutes
- Introduction to Informed Consent•10 minutes
Develop knowledge of informed consent processes, adverse drug reactions, and safety classification methods in clinical trials.
What's included
9 videos4 assignments
9 videos•Total 86 minutes
- process of icf•10 minutes
- Adverse Drug Reaction•11 minutes
- Casualty Classification•11 minutes
- Seriousness Classification•4 minutes
- Mechanism Classification•8 minutes
- introduction to project management•8 minutes
- Project Management Stages (Basics)•11 minutes
- Project Management Stages (Advanced)•9 minutes
- introduction to schedule y•13 minutes
4 assignments•Total 60 minutes
- Informed Consent & Drug Safety•30 minutes
- ICF Process & Safety Basics•10 minutes
- Safety Evaluation Methods•10 minutes
- Project Management in Clinical Research•10 minutes
Explore clinical trial execution, roles and responsibilities, CRO functions, and detailed progression through trial phases.
What's included
9 videos4 assignments
9 videos•Total 80 minutes
- changes in schedule y•7 minutes
- Roles & Responsibilities (Intro)•11 minutes
- Roles & Responsibilities (Details)•6 minutes
- Appendix & Documentation•10 minutes
- introduction to cro•8 minutes
- Phase I Trials (Overview)•7 minutes
- Phase I Trials (Process)•8 minutes
- Phase 2•11 minutes
- phase3•12 minutes
4 assignments•Total 60 minutes
- Clinical Operations & Trial Phases•30 minutes
- Regulatory Updates & Roles•10 minutes
- Documentation & CRO•10 minutes
- Clinical Trial Progression•10 minutes
Analyze ICH guidelines, GCP standards, ICMR principles, and ethical practices governing global clinical research.
What's included
9 videos4 assignments
9 videos•Total 78 minutes
- ICH Guidelines Introduction•12 minutes
- ICH Framework & Scope•6 minutes
- ich categories•7 minutes
- phase 4 intro•7 minutes
- types of phase 4•12 minutes
- intro ICMR•5 minutes
- principal of icmr•10 minutes
- introduction to gcp•9 minutes
- ICH-GCP Sections Overview•11 minutes
4 assignments•Total 60 minutes
- Global Guidelines & Ethics•30 minutes
- ICH Guidelines•10 minutes
- Advanced Trial Phases•10 minutes
- Ethical & GCP Standards•10 minutes
Apply SOP development, reporting systems, pharmacovigilance processes, and quality-of-life assessments in trials.
What's included
9 videos4 assignments
9 videos•Total 78 minutes
- ICH-GCP Detailed Sections•11 minutes
- introduction to sop•7 minutes
- SOP Writing Basics•8 minutes
- SOP Writing Process•8 minutes
- introduction•11 minutes
- what where who to report•6 minutes
- medwatch•8 minutes
- QOL intro•6 minutes
- QOL in detail•13 minutes
4 assignments•Total 60 minutes
- SOPs & Reporting Systems•30 minutes
- GCP & SOP Fundamentals•10 minutes
- SOP Implementation & Reporting•10 minutes
- Pharmacovigilance & QOL•10 minutes
Examine pharmacological principles, medical writing, biostatistics, and clinical trial design methodologies.
What's included
9 videos4 assignments
9 videos•Total 79 minutes
- introduction to pharmacology•11 minutes
- pharmacodynamics•9 minutes
- pharmacokinetics•8 minutes
- introduction to medical writing•8 minutes
- characteristics•10 minutes
- introduction to clinical trail design and biostats•8 minutes
- Clinical Trial Design Basics•8 minutes
- Clinical Trial Design Methods•7 minutes
- selection of design•9 minutes
4 assignments•Total 60 minutes
- Pharmacology & Trial Design•30 minutes
- Pharmacology Fundamentals•10 minutes
- Medical Writing & Biostatistics•10 minutes
- Clinical Trial Design•10 minutes
Evaluate outsourcing strategies, fraud prevention, bioequivalence studies, and communication skills in clinical research.
What's included
11 videos4 assignments
11 videos•Total 99 minutes
- Outsourcing Introduction•9 minutes
- Types of Contract•6 minutes
- Outsourcing Process•8 minutes
- Outsourcing Process Continue•8 minutes
- Introduction Fraud and Misconduct•9 minutes
- Prevalence of Fraud•11 minutes
- Introduction to Bio Equivalence Studies•11 minutes
- Parameters Bio Equivalence•12 minutes
- FDA Guideline•3 minutes
- Definition Communication•10 minutes
- communication Skill in Clinical Research•13 minutes
4 assignments•Total 60 minutes
- Outsourcing, Compliance & Communication•30 minutes
- Outsourcing in Clinical Research•10 minutes
- Risk, Fraud & Bioequivalence•10 minutes
- Bioequivalence & Communication Skills•10 minutes
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