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Coursera

Drug Development and Clinical Research

EDUCBA via Coursera

Overview

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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.

Syllabus

  • Drug Discovery & Regulatory Foundations
    • Understand the fundamentals of drug discovery, development stages, and regulatory frameworks shaping modern clinical research.
  • Informed Consent & Drug Safety
    • Develop knowledge of informed consent processes, adverse drug reactions, and safety classification methods in clinical trials.
  • Clinical Operations & Trial Phases
    • Explore clinical trial execution, roles and responsibilities, CRO functions, and detailed progression through trial phases.
  • Global Guidelines & Ethics
    • Analyze ICH guidelines, GCP standards, ICMR principles, and ethical practices governing global clinical research.
  • SOPs & Reporting Systems
    • Apply SOP development, reporting systems, pharmacovigilance processes, and quality-of-life assessments in trials.
  • Pharmacology & Trial Design
    • Examine pharmacological principles, medical writing, biostatistics, and clinical trial design methodologies.
  • Outsourcing, Compliance & Communication
    • Evaluate outsourcing strategies, fraud prevention, bioequivalence studies, and communication skills in clinical research.

Taught by

EDUCBA

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