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What You'll Learn

Clinical research is the backbone of every new drug, vaccine, and medical device that reaches patients. India is one of the fastest-growing clinical trial markets in the world — with CROs, pharma companies, and regulatory agencies constantly expanding. This ACPCRM course takes you from fundamentals to job-readiness, covering trial management, pharmacovigilance, regulatory submissions, and medical writing with hands-on projects.

  • Clinical trial phases (I-IV), design & protocol development
  • Good Clinical Practice (ICH-GCP) guidelines & ethics
  • Pharmacovigilance — adverse event reporting & drug safety
  • Regulatory affairs — CDSCO, FDA, EMA submission processes
  • Medical writing — protocols, CSR, IB & regulatory documents

Ideal Candidates

Life science, pharmacy & medical graduates

B.Sc/M.Sc (Biology, Microbiology, Biotechnology) freshers

Healthcare professionals transitioning to clinical research

Anyone interested in the pharmaceutical R&D industry

Course Modules

From clinical research fundamentals to career-ready skills

  • Drug discovery & development pipeline
  • Clinical trial phases (Phase I-IV)
  • Key stakeholders — sponsor, CRO, investigator
  • Ethics committees & informed consent
  • Regulatory landscape in India & globally
  • ICH-GCP E6(R2) guidelines in depth
  • Roles & responsibilities of investigators
  • Informed consent process & documentation
  • CDSCO & Schedule Y regulations
  • FDA 21 CFR & EMA guidelines overview
  • Study start-up & site selection
  • Protocol development & amendments
  • CRF design & data collection
  • Monitoring visits (SIV, IMV, COV)
  • Trial master file & essential documents
  • Adverse event (AE) vs adverse drug reaction (ADR)
  • Individual Case Safety Reports (ICSRs)
  • MedDRA coding & signal detection
  • PSUR/PBRER & risk management plans
  • WHO Drug Dictionary & safety databases
  • IND/NDA/ANDA submission processes
  • CTD/eCTD format & structure
  • CDSCO approval pathways
  • Post-marketing surveillance
  • Patent & exclusivity fundamentals
  • Protocol synopsis & full protocol writing
  • Clinical study reports (CSR)
  • Investigator's brochure (IB)
  • Regulatory submission documents
  • SOPs & guidelines for documentation
  • Clinical data management overview
  • CDISC standards (SDTM, ADaM basics)
  • Introduction to SAS for clinical data
  • Project work & case studies
  • Interview preparation & certifications guide

Tools & Technologies You'll Master

ICH-GCP Guidelines CDSCO Portal FDA FAERS MedDRA WHO Drug Dictionary Oracle Argus (overview) SAS (basics) CDISC Standards eCTD Publishing MS Excel REDCap (overview) PubMed ClinicalTrials.gov CTMS overview

Hands-On Projects

Real-world clinical research projects for your portfolio

Clinical Trial Protocol Design

Design a complete Phase III clinical trial protocol including objectives, methodology, endpoints, statistical plan & informed consent form.

Pharmacovigilance Case Processing

Process 20+ ICSRs using MedDRA coding, causality assessment (WHO-UMC & Naranjo), and create aggregate safety reports.

Regulatory Submission Dossier

Prepare a mock CTD Module 1 regulatory submission dossier for CDSCO including cover letter, application form & administrative documents.

Medical Writing Portfolio

Write a protocol synopsis, clinical study report summary, and investigator's brochure section for a simulated clinical trial.

Career Outcomes

Roles our graduates land after completing this program

Clinical Research Associate (CRA) Clinical Data Manager Pharmacovigilance Associate Regulatory Affairs Executive Medical Writer Clinical Project Coordinator

Average Salary Range: ₹3L – ₹7L per annum (entry to mid-level)

Frequently Asked Questions

Graduates in life sciences, pharmacy, medicine, nursing, dentistry, or allied health sciences. B.Sc/M.Sc students with science backgrounds are also eligible.

Yes. India is a major hub for clinical trials. CROs like IQVIA, Syneos Health, Parexel, Covance, and Indian pharma companies are constantly hiring clinical research professionals.

ACRP (Association of Clinical Research Professionals) certification, SOCRA CCRP, and NIDA clinical trials certification are popular options post-course.

Yes. Module 4 is dedicated to pharmacovigilance including ICSR processing, MedDRA coding, signal detection, and safety reporting.

The course provides a basic introduction to SAS for clinical data analysis. For advanced SAS programming, consider a dedicated SAS course.

Yes. Flexible EMI options available. Contact our admissions team at +91 94227 61663 for details.

Ready to Enter Clinical Research?

Master clinical trials & pharmacovigilance in 4 months. Enroll today.

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