
India's Largest Clinical Research Training Program
The Professional Diploma in Clinical Research (PDCR) is India's largest and widely recognized clinical research training program, designed to cultivate high-calibre professionals for the pharmaceutical, biotechnology, and healthcare research sectors.
This comprehensive skill-development programme offers a robust understanding of drug discovery, clinical trial operations, regulatory frameworks, and internationally accepted Good Clinical Practice (GCP) standards.
Participants receive four meticulously curated learning modules along with an Assignment Workbook that together provide a comprehensive grounding in clinical trial methodology. Delivered over six months through a flexible distance-learning model, the PDCR programme enables learners to progress at their own pace while balancing demanding professional or academic commitments.
Ideal for graduates and working professionals seeking a distinguished entry or advancement in the clinical research domain, PDCR equips participants with industry-ready competencies and a competitive edge in a rapidly evolving global landscape.
What you'll learn
Drug development phases, GCP, and global trial norms
Clinical trial conduct, monitoring, and documentation
Regulatory pathways including IND/NDA and Indian CT rules
Stakeholder roles across sponsor, investigator, CRA/CRC, etc.
Data management, safety reporting, and core biostatistics
Ethics compliance and quality systems for trial integrity
Why choose this Course?
Self-Paced Learning
Flexible format that fits around professional or academic schedules.
24/7 Expert Academic Support
24/7 faculty guidance for queries, feedback, and learning clarity.
Industry-Ready Content
Curriculum mapped to current industry practices and GCP standards.
A Standout Portfolio
Assignments that showcase trial design and operational know-how.
Real-World Projects & Case Studies
Applied real-world case studies reflecting actual scenarios.
Placement Assistance
Career guidance and interview readiness for industry roles.
Course Details
Module 1: Introduction to Pharmaceutical Medicine
Duration: Self-Paced
Topic Covered
The Drug Development Process
New Drug Discovery
Clinical Development of Drug
Essential Clinical Trial Documents
Clinical Trials Terminology
Skills Acquired
Clinical research fundamentals
Drug discovery lifecycle
Clinical trial documentation
Trial terminology literacy
Development process insight
Module 2: Good Clinical Practice (GCP) Foundations
Duration: Self-Paced
Topic Covered
History of GCP - milestones in the evolution of GCP
Principles of GCP
Applicable GCP Guidelines
Declaration of Helsinki
Clinical Study Process
The Management of Clinical Studies (Sponsor)
Ethics in Clinical Research
Informed Consent
Serious Adverse Event (SAE)
Challenges in the Implementation of GCP Guidelines
Biostatistics
Skills Acquired
GCP compliance
Ethics and informed consent
SAE reporting discipline
Study management fundamentals
Biostatistics basics
Module 3: Drug Regulatory Affairs (Clinical Trials)
Duration: Self-Paced
Topic Covered
Overview of Regulatory Environment in USA, Australia, Europe and India
Clinical Trial Application Requirements in India
Import- Export of Clinical Trial Drugs in India
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule
IND/ANDA/New Drug Application
Skills Acquired
Global clinical regulations
IND/ANDA submission know-how
Indian CT application prep
Import-export compliance
HIPAA and privacy readiness
Module 4: Roles & Responsibilities of Clinical Trial Personnel
Duration: Self-Paced
Topic Covered
Roles & Responsibilities of Sponsor
Roles & Responsibilities of Investigator
Roles & Responsibilities of ERB/IRB/IEC
Roles & Responsibilities of CRA /Monitor
Roles & Responsibilities of Auditor
Roles & Responsibilities of Clinical Research Coordinator
Roles & Responsibilities of CRO's
Roles & Responsibilities of Regulatory Authorities
Roles & Responsibilities of Clinical Data Manager (CDM)
Roles & Responsibilities of Clinical Biostatistician
Skills Acquired
Stakeholder coordination
Site and investigator management
Monitoring and auditing practice
Data management collaboration
Biostatistics partnership
Course Schedule
1
Receive Study Material
Upon registration, you will receive four comprehensive Learning Modules along with an Assignment Workbook.
2
Study & Complete Assignments
Go through the modules and complete the assignments within the standard 4.5-month duration.
3
Option for Early Completion
If you wish to finish sooner, you may submit your completed workbook with an early assessment request.
4
Assessment
Your Assignment workbook is evaluated based on the qualification criteria.
5
Earn Your Certificate
After successful assessment, you will be awarded a Certificate of Completion.
Registration Process
Three-step registration process:
1
Get the Registration Link/QR
Receive the registration link and QR code from us.
2
Complete the Form & Payment
Fill out the registration form and pay the course fee using the QR code.
3
Receive Confirmation
Get an acknowledgement call confirming your successful registration.
Program Fee
Indian Participants
₹14000
Foreign Participants
$350
This course includes
Duration
Self-Paced
Lessons
4
Students
500+
Language
English
Certificate
Yes
Contact for more details of the course
Student Testimonials
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JD
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