PG-Diploma In Clinical Research (PGDCR)

12 Months Program

The Post Graduate Diploma in Clinical Research (PGDCR) is a specialized one-year program designed to equip aspiring professionals with in-depth knowledge and practical skills in the clinical research domain. This program bridges the gap between academic learning and industry requirements, preparing students for a thriving career in pharmaceuticals, biotechnology, contract research organizations (CROs), and healthcare institutions.

Learning Mode:

Residential (Classroom)

Distance (Online)

Course Description:

The Post Graduate Diploma in Clinical Research (PGDCR) offered by IILS is a comprehensive, one-year program thoughtfully structured into 4 semesters, each spanning 3 months. It is designed to provide students with a robust academic and practical foundation in clinical research while aligning with current industry demands across pharmaceuticals, biotechnology, Medical Device Organization, CROs, and healthcare sectors.

Across 16 in-depth modules, the program covers a full spectrum of clinical research knowledge—from fundamentals to advanced applications. The journey begins with an introduction to clinical research, pharmacology, and ethical and regulations, gradually advancing into study design, regulatory requirements, project management, and trial execution. As the program progresses, students gain specialized exposure to data management, medical writing, biostatistics, and quality assurance—essential for real-world clinical trial environments.

The curriculum integrates theoretical understanding with practical insights, case-based discussions, and industry-relevant tools to ensure graduates are career-ready. By the end of the program, students are equipped not only with subject mastery but also with critical thinking, analytical, and operational skills needed to excel in the evolving landscape of clinical research.

At the end of each semester, candidates must appear for an internal assessment (semester examination). A minimum score of 50% is required to successfully pass and progress to the next semester. This evaluation process ensures academic accountability and a consistent pace of learning throughout the program.

Course Curriculum:

SEMESTER I

SEMESTER II

SEMESTER III

SEMESTER IV

Eligibility Requirements

Educational Qualifications

Candidates who have passed with a minimum of 50% Graduate or Postgraduate + Internal Assessment + P. Interview

Admission Process

Industries Involved

Pharmaceutical:

Biotechnology

Medical Device Companies

CROs

Growing Demand for Clinical Research Professionals

Market Size Overview:

Growth by Region:

Drivers of Market Growth

Increased R&D investment by pharmaceutical and biotechnological companies globally.
Focus on developing novel treatments for chronic diseases.
Rising demand for outsourcing of R&D activities to CROs.
Strategic Collaborations:
Example: In July 2021, the Beijing Illness Challenge Foundation (ICF) in China formed a strategic relationship with Parexel to improve patient participation in clinical trials for rare diseases.

Impact of COVID-19 on the Market

Challenges During COVID-19:

Post-COVID Recovery:

Notable Partnerships:

Clinical Trial Market Trends

Pharmaceutical and Biotechnological Companies Increasing R&D Investments

Companies in medical devices, pharmaceuticals, and biopharmaceuticals are allocating significant resources to the development of new technologies and medications.
Focus is on improving R&D efficiencies and developing novel therapeutics.
Increased investment in R&D by pharmaceutical and biotechnology companies is expected to drive market growth.

Clinical Trial Market Growth Factor

Rising Prevalence of Chronic Diseases

Increased incidence of chronic diseases like diabetes, cancers, neurological disorders, and arthritis is driving demand for the development of effective therapeutics.
Example: In June 2023, over half a billion people globally live with diabetes, projected to reach 1.30 billion in the next 30 years (Source: University of Washington).
Cancer Prevalence: Europe accounted for 22.8% of all cancer cases in 2020 (Source: Globocan).

Rising Number of Clinical Trials Globally

Restraining Factors in Clinical Trials

Limited Availability of Skilled Workforce

High Costs of Clinical Trials

The cost of drug development is substantial, averaging USD 2.60 billion per new drug (Source: Tufts Center for the Study of Drug Development).
Only 12% of drug candidates in clinical trials gain U.S. FDA approval.
Complexity in study design, lengthy time frames, and regulatory requirements also contribute to the high costs and time involved in clinical trials.

Clinical Trials in India

Current Clinical Trials: 74,516 clinical trials registered and ongoing in India (Source: CTRI).
Market Size (2022): Estimated at USD 2.07 billion.
Projected Market Size (2030): Expected to reach USD 3.88 billion.
Cost-effective trial strategies and a simplified regulatory system.
Trained professionals in clinical research, medicine, and IT support.
Availability of vulnerable populations, diverse patient groups, and experienced physicians.
India has the potential to increase global clinical trials by 5x in the coming years.
Current participation in global trials is just 3.2%, while the country contributes over 15% of the global burden for many prevalent diseases (e.g., respiratory infections, cardiovascular, diabetes, cervical cancer).

Workspaces of Clinical Research Personnel

Where Clinical Research Professionals Work?

&...Central Labs_Global Central Labs

India’s Leading Central Labs

Types of Roles in CR Domain

Graduates of the PGDCR program can pursue roles such as:

At Hospital_the Investigative Site

The location(s) at or from where trial-related activities are conducted under the investigator’s/institution’s supervision.

Interacting Directly with Patients (Research Subjects)

Principal Investigator (PI)

A person responsible for the conduct of the clinical trial, including the trial participants for whom that person has responsibility during the conduct of the trial. If a trial is conducted by a team of individuals, the investigator is the responsible leader of the team and may be called the principal investigator. Where an investigator/institution is referenced in this guideline, it describes expectations that may be applicable to the investigator and/or the institution in some regions. Where required by the applicable regulatory requirements, the “investigator” should be read as “investigator and/or the institution.”

Responsibilities:

Sub-Investigator (Sub-I)

Any individual member of the clinical trial team designated and supervised by the investigator to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

Responsibilities:

Clinical Research Coordinator (CRC)

Average Salary Ranges (₹ 15,000 – ₹ 35,000)

Clinical Research Coordinator (CRC) is responsible for overseeing and managing the day-to-day operations of clinical trials. They support the Principal Investigator (PI) and Sub-Investigator (Sub-I) in all aspects of the study, including start-up, ethics approval, scheduling patient visits, assisting with data collection, managing study documents, and addressing issues identified during monitoring visits. CRCs play a key role in ensuring that clinical trials are conducted in compliance with the study protocol, regulatory requirements, ethical standards, and Good Clinical Practices (GCPs).

Responsibilities:

Clinical Research Nurse (CRN)

Similar to the Clinical Research Coordinator (CRC), the Clinical Research Nurse (CRN) works under the supervision of the Principal Investigator (PI) or Sub-Investigator (Sub-I). While performing many of the same tasks as a CRC, the CRN has a more hands-on role in patient care during clinical trials. This includes evaluating subject eligibility, conducting study-related procedures, educating participants about the investigational product, and assessing adverse events.

Responsibilities:

Administers treatments and conducts medical assessments.
Observes and reports patient reactions, side effects, and progress.
Acts as a bridge between patients and the clinical research team.
Ensures patients’ questions about the trial are answered.

Average Salary Ranges (₹ 20,000 – ₹ 41,000)

Clinical Research Pharmacists (CRP)

Clinical Research Pharmacists (CRPs) are responsible for providing specialized pharmacy expertise in the development, management, and handling of investigational products at both the program and protocol levels. Their primary objective is to ensure the safe and effective use of investigational products at clinical sites, including the creation of detailed pharmacy manuals for use by healthcare personnel.

Responsibilities:

Average Salary Ranges (₹ 15,000 – ₹ 45,000)

Ethics Committee (EC) Coordinator

An Ethics Committee (EC) Coordinator is responsible for managing the activities, operations, and administration of the ethics committee, which oversees the ethical standards and compliance of clinical trials and other research activities within institutions such as hospitals, universities, or corporations.

Responsibilities:

AdminAgenda Preparation & Meeting Coordination
Document Management
Communication with EC Members
Compliance & Guidelines
Coordination with CRCs & Site Head
Chennai Ethics Committee (CEC) Specific Duties
Document Verification & Acknowledgment

Average Salary Ranges (₹ 25,000 – ₹ 75,000)

The Types of Designations That Exist In Operation

Sponsor | Operations

Within Industry (Biopharmaceutical / Medical Device Companies, Contract Research Organizations [CROs]

Director of Clinical Operations
Clinical Operations Manager
Project Manager (Clinical Trials)
Associate Project Manager (ACPM)
Clinical Research Associate (CRA)
Clinical Trial Assistant (CTA)

Director of Clinical Operations

The Director of Clinical Operations is a senior-level professional responsible for overseeing the planning, execution, and management of clinical trials within a pharmaceutical, biotech, or healthcare organization. They ensure that clinical trials are conducted efficiently, within budget, on schedule, and in compliance with regulatory and ethical guidelines, such as Good Clinical Practice (GCP). The Director of Clinical Operations plays a pivotal role in leading cross-functional teams, managing trial logistics, and aligning clinical strategies with the organization’s goals.

Responsibilities:

Strategic Planning & Oversight
Team Leadership & Management
Budget Management
Regulatory Compliance
Vendor and CRO Management
Risk Management & Problem-Solving
Monitoring & Reporting
Process Improvement
Stakeholder Communication

Average Salary Ranges (₹8.0 Lakhs to ₹ 93.0 Lakhs )

Clinical Operations Manager

Average Salary Ranges (₹5.0 Lakhs to ₹ 40.0 Lakhs )

A Clinical Operations Manager is responsible for overseeing the day-to-day operations of clinical trials. They manage the clinical trial process, ensuring that trials are conducted in compliance with regulatory requirements, timelines, and budgets. This role includes coordinating teams, managing resources, and liaising between different stakeholders such as investigators, sponsors, and regulatory authorities. They ensure the smooth and efficient execution of clinical studies and play a critical role in ensuring the success of clinical trials within a research organization or pharmaceutical company.

Responsibilities:

Team Management & Leadership
Budget & Resource Management
Regulatory Compliance
Vendor Coordination
Risk Assessment & Mitigation
Monitoring & Reporting
Process Improvement
Stakeholder Communication

Project Manager (Clinical Trials)

A Project Manager (PM) is responsible for overseeing the planning, execution, and completion of clinical trials. They ensure that clinical studies are conducted on time, within budget, and according to regulatory requirements. The role involves coordinating cross-functional teams, managing resources, and maintaining communication between sponsors, clinical sites, and regulatory bodies. The Project Manager ensures the trial progresses smoothly, addressing challenges and risks to ensure successful study outcomes.

Responsibilities:

Team Management & Leadership
Budget & Resource Management
Regulatory Compliance
Vendor Coordination
Risk Management & Problem-Solving
Monitoring & Reporting
Process Improvement
Stakeholder Communication

Average Salary Ranges (₹5.0 Lakhs to ₹ 25.0 Lakhs )

Associate Project Manager (ACPM)

Average Salary Ranges (₹5.0 Lakhs to ₹ 25.0 Lakhs )

An Associate Project Manager (APCM) in clinical trials supports the Project Manager (PM) in overseeing the planning, execution, and completion of clinical studies. They assist in ensuring that clinical trials run smoothly, on time, and within budget. The Associate Project Manager is responsible for handling day-to-day project tasks, coordinating with cross-functional teams, and maintaining communication with stakeholders to ensure the success of the trial. This role is often an entry- to mid-level position, providing an opportunity for growth into full project management.

Responsibilities:

Project Coordination & Support
Team Collaboration
Budget & Resource Tracking
Regulatory Documentation & Compliance
Vendor & CRO Support
Monitoring & Reporting
Stakeholder Communication
Administrative Support

Clinical Research Associate (CRA)

A Clinical Research Associate (CRA) is a vital member of the clinical trials team, responsible for monitoring the progress of clinical trials at various sites. They ensure that the trials are conducted according to the study protocol, regulatory guidelines, and Good Clinical Practice (GCP). CRAs are responsible for overseeing data collection, patient safety, compliance with regulatory standards, and reporting of trial progress to sponsors. They play a crucial role in ensuring the quality and integrity of clinical trial data.

Responsibilities:

Site Monitoring & Management
Data Management & Reporting
Regulatory Compliance & Documentation
Site Support & Training
Collaboration with Study Team
Study Progress Tracking

Average Salary Ranges (₹ 35,000 – ₹ ₹ 2.5 Lakhs)

Clinical Trial Assistant (CTA)

Average Salary Ranges (₹ 25,000 – ₹ 50,000)

A Clinical Trial Assistant (CTA) supports the clinical trial team with administrative and operational tasks throughout the lifecycle of clinical trials. The CTA is responsible for maintaining essential trial documentation, organizing meetings, and ensuring that the necessary regulatory and clinical trial documents are up to date and properly filed. They play a key role in facilitating communication between the clinical team and stakeholders.

Responsibilities:

Document Management
Trial Documentation & Filing
Study Set-up & Support
Coordination of Meetings & Communications
Tracking & Reporting of Study Milestones
Regulatory Submissions Support
Study Progress Monitoring
Preparing Study Reports
Audit & Inspection Preparation

The Types of Designations In Clinical Data Manager

Clinical Data Manager (CDM)

A Clinical Data Manager (CDM) oversees the collection, processing, and analysis of data from clinical trials, playing a vital role in the development of new medical treatments by ensuring the accuracy, completeness, and regulatory compliance of trial data.

Clinical Data Managers collaborate with other members of the clinical research team, including Clinical Research Associates, Data Analysts, and Biostatisticians, to ensure that data management processes are executed efficiently and precisely. Their responsibilities include designing and implementing data management plans, developing guidelines for data entry, and overseeing quality control processes for the data collected.

Responsibilities:

Data Collection & Management
Design case report forms (CRFs)
Database Design & Maintenance
Data Cleaning & Validation
Ensuring Data Accuracy & Integrity
Regulatory Compliance & Standards
Data Review & Query Resolution
Collaboration with Cross-Functional Teams
Audit & Inspection Support
Data Export & Submission

Average Salary Ranges (₹ 45,000 – ₹ 2.5 lakh)

Clinical Data Coordinator (CDC)

A Clinical Data Coordinator (CDC) is responsible for supporting the management and processing of data collected during clinical trials. The CDC works closely with the Clinical Data Manager (CDM) to ensure that the data is collected, entered, and validated accurately, adhering to regulatory and quality standards.

Responsibilities:

Data Entry & Management
Data Validation & Cleaning
Query Management & Resolution
Collaboration with Clinical Teams
Compliance with Regulatory Standards
Supporting Data Audits & Inspections
Support in Data Analysis

Average Salary Ranges (₹ 35,000 – ₹ ₹ 1.5 Lakhs )

Clinical Data Analyst (CDA)

A Clinical Data Analyst is responsible for analyzing and interpreting data collected from clinical trials. They ensure that the data is accurate, complete, and compliant with regulatory standards. Their work is crucial in identifying trends, validating trial outcomes, and supporting decision-making in clinical research.

Responsibilities:

Data Analysis & Interpretation
Data Cleaning & Validation
Generating Reports & Insights
Trend Analysis & Outcome Assessment
Collaborating with Cross-Functional Teams
Ensuring Data Integrity & Accuracy
Compliance with Regulatory Standards
Data Query & Resolution
Supporting Statistical Analysis
Contributing to Study Reports & Publications

Average Salary Ranges (₹ 35,000 – ₹ ₹ 1.5 Lakhs )

Quality Assurance

Electronic Trial Master File (eTMF)

CRO| Operations-eTMF

e-TMF Manager
e-TMF Specialist
TMF Coordinator
TMF Administrator
TMF Document Specialist
TMF Associate
TMF Compliance Lead
e-TMF System Administrator
TMF Quality Control Specialist
e-TMF Project Manager
TMF Archivist
TMF Auditor
Senior e-TMF Coordinator
e-TMF Trainer