Clinical Research

Learn foundations of clinical trials, regulatory affairs, pharmacovigilance, clinical data management and advanced real-world research methods through hands-on projects and case studies.

Learning Mode

Online

Real-Time Projects

Practical Hands-On Learning

Expert Mentorship

Guided by Industry Professionals

Career Support

Placement Assistance

About the Course

The Clinical Research course by SkillDzire covers clinical trial fundamentals, ethics & GCP, regulatory affairs, pharmacovigilance, clinical data management, biostatistics & SAS, scientific writing, audits, and advanced topical case studies including real-world evidence and post-marketing surveillance. This program includes hands-on tasks and project work tailored for careers in clinical operations, regulatory roles, data management and pharmacovigilance.

Fundamentals of clinical trial design, ethics and regulations

Hands-on exposure: protocol writing, CRF, EDC and safety reporting

Biostatistics & SAS basics for analysis and reporting

Career support & industry-aligned projects

Curriculum

Clinical Research Foundations

  • Introduction to Clinical Research
  • History and Phases of Clinical Trials
  • Drug Discovery and Development Process

Ethics & Good Clinical Practice (GCP)

  • Ethical Principles (Helsinki, Belmont)
  • ICH-GCP Guidelines
  • Informed Consent Process

Clinical Trial Design

  • Types of Study Designs
  • Randomization & Blinding
  • Protocol Development
  • Subject Recruitment & Retention

Regulatory Affairs

  • Regulatory Bodies (FDA, EMA, DCGI)
  • IND, NDA, ANDA Submissions
  • Trial Registration & Approval Process

Pharmacovigilance (PV)

  • Introduction to PV
  • Adverse Drug Reactions (ADR)
  • Signal Detection
  • Case Processing & Reporting

Clinical Data Management

  • CRF Design
  • Data Validation & Query Management
  • EDC Systems (e.g., Medidata, Oracle)
  • Data Lock & Archival

Biostatistics & SAS

  • Basic Biostatistics Concepts
  • p-values, CI, Hypothesis Testing
  • Introduction to SAS Programming

Medical / Scientific Writing

  • Clinical Study Reports (CSR)
  • Protocols, Informed Consent Forms
  • Literature Reviews

Audits & Risk Management

  • Clinical Trial Audits
  • Risk-Based Monitoring (RBM)
  • Quality Assurance

Hands-On Real-Time Exposure Tasks

  • mRNA-Based Vaccine Development & Clinical Trial Protocols (Beyond COVID-19)
  • AI & Machine Learning Applications in Clinical Trial Design and Patient Recruitment
  • Phase 2/3 Clinical Trials of GLP-1 Agonists (e.g., Semaglutide, Tirzepatide) for Obesity & Diabetes
  • Pharmacogenomics & Personalized Medicine in Oncology Trials
  • Post-Marketing Surveillance & Real-World Evidence (RWE) Studies for Biologics & Biosimilars
  • Comparative Study: CRISPR-Based Gene Therapy Trials vs. Conventional Treatments
  • Patient-Centered Outcomes & Adherence Studies in Chronic Disease Management (Digital Health Integration)
  • Retrospective & Prospective Studies on Long COVID and Post-Vaccine Syndromes
  • Cost-Effectiveness & Health Economics Evaluation of Novel Cancer Immunotherapies
  • Herbal & Nutraceutical Clinical Trials with Standardized Protocol Design
Download Full Curriculum (PDF)

Projects You Will Work On

Clinical Trial Protocol Development

Design a complete phase II/III protocol including objectives, endpoints, inclusion/exclusion criteria and statistical plan.

Pharmacovigilance Case Processing

Work through ADR case intake, MedDRA coding, seriousness assessment and reporting workflows (CIOMS/CIOMS/VAERS style).

Clinical Data Management & CRF Design

Create CRFs, define edit checks, perform data validation and prepare datasets for lock using mock EDC workflows.

Student Testimonials

"This program deepened my understanding of trial operations and pharmacovigilance workflows."

- Dr. Asha Rao

"Hands-on EDC and CRF exercises helped me prepare for clinical data manager roles."

- Vivek Menon

"Excellent coverage of regulatory affairs and scientific writing; very industry-relevant."

- Rekha Patel