Clinical Research

This course covers the end-to-end drug development process, clinical trial phases, Good Clinical Practice (GCP) guidelines, and global regulatory requirements from authorities such as CDSCO (India), US FDA, EMA (Europe), MHRA (UK), TGA (Australia), HPFB (Canada), and PMDA (Japan). With hands-on training in clinical trial documentation, regulatory submissions, site management, contracts, medical writing, and audits, this program equips participants with the skills required to pursue successful careers in pharmaceutical companies, contract research organizations (CROs), regulatory agencies, and hospitals.

Key Learning Modules:

1. Introduction to Clinical Research

✔ Definition and scope of Clinical Research

✔ Types of clinical studies: Interventional, Observational, BA/BE studies

✔ Overview of the clinical trial process

✔ Career opportunities and growth in Clinical Research

2. Drug Development & Phases of Clinical Trials

✔ Preclinical and clinical development

✔ Phase I-IV trials: Objectives, timelines, and key activities

✔ Role of Sponsors, Investigators, and Ethics Committees

3. Clinical Trial Regulations & Guidelines

✔ Indian Regulations (CDSCO, Schedule Y, New Drugs & Clinical Trial Rules)

✔ US FDA Regulations (21 CFR Parts 50, 54, 56, 312, 314)

✔ European (EMA), UK (MHRA), Australia (TGA), Canada (HPFB), Japan (PMDA) Regulations

✔ ICH-GCP Compliance in Clinical Trials

4. Key Clinical Trial Documents

✔ Clinical Trial Protocol

✔ Investigator’s Brochure (IB)

✔ Informed Consent Form (ICF) & Ethics Committee Approval

✔ Case Report Forms (CRF) & Clinical Study Reports (CSR)

5. Clinical Trial Procedures & Site Management

✔ Investigator & Site Selection

✔ Site Initiation Visit (SIV), Site Monitoring Visit (SMV), Site Close-Out Visit (SCV)

✔ Budgeting & Contract Negotiations (CDA, MSA, CTA)

✔ Subject Recruitment & Retention Strategies

6. Safety Reporting & Pharmacovigilance in Clinical Trials

✔ Adverse Event (AE) & Serious Adverse Event (SAE) Reporting

✔ Risk Management & Safety Monitoring

7. Clinical Data Management & Medical Writing

✔ Data collection, validation & query resolution

✔ Medical writing principles: Protocols, Investigator Brochures, Study Reports ✔ Biostatistics & Interpretation of Trial Results

8. Audits & Inspections in Clinical Research

✔ Regulatory inspections and audit readiness

✔ Quality control, assurance, and SOPs compliance Who Should Attend?

✅ Aspiring Clinical Research Professionals

✅ Pharmaceutical & Healthcare Graduates (Pharmacy, Life Sciences, MBBS, Nursing, etc.)

✅ Regulatory Affairs & Pharmacovigilance Professionals

✅ Medical Writers & Clinical Data Managers

✅ Anyone Seeking a Career in Clinical Trials, CROs, or Pharma Industry