Clinical research involves scientific studies in human participants to evaluate the safety, efficacy, and quality of medicines, medical devices, diagnostic tools, and treatment approaches. Clinical research ultimately supports the prevention, diagnosis, treatment, and management of diseases, contributing to advancements in modern healthcare.

What is a Clinical Trial?

A clinical trial is a scientifically designed study conducted in human participants to evaluate the safety, efficacy, and optimal use of new medicines, vaccines, medical devices, or treatment approaches. These studies follow strict international ethical and regulatory guidelines and begin only after sufficient safety data from pre-clinical (laboratory and animal) studies and approvals from regulatory and ethics authorities.

What is the St. Xavier’s College PG Diploma in Clinical Research all about?

Clinical research and pharmacovigilance are experiencing significant growth globally and across Asia, driven by the rapid expansion of the pharmaceutical and biotechnology sectors and increasing regulatory requirements. In India alone, the industry is currently valued at USD 3–4 billion and is projected to grow to USD 7–10 billion by 2030, creating strong demand for skilled professionals in clinical trials, clinical data management, pharmacovigilance, and regulatory affairs. This growing demand has created the need for professionally designed training programs in clinical research.

The St. Xavier’s College PG Diploma in Clinical Research addresses this need through a carefully designed, industry-oriented curriculum delivered by experienced faculty, industry professionals, and subject matter experts. The program provides hands-on exposure to clinical research activities and practical aspects of the field, enabling students to develop relevant skills and real-world understanding required to step confidently into the clinical research ecosystem.

In addition, this course invites clinical research professionals to upgrade their clinical research knowledge by enrolling into specific modules as outlined in the course curriculum.

Vision

To deliver a high-quality clinical research program that develops competent, industry-ready professionals through a carefully designed curriculum led by experienced industry faculty and subject matter experts, providing practical exposure and equipping high-potential students with the knowledge, skills, and competencies needed to excel in the clinical research industry.

Course Curriculum

The curriculum is designed to provide basic and practical knowledge on clinical research, clinical trial conduct, the regulations governing it, and the required communication & organizational skills.

The curriculum is sub-divided into 6 modules and the topics covered under each module are as follows:

Module 1 Clinical Research – Overview, Ethics & Regulations (14 Credits)

Module 2 Clinical Trial Planning & Design (12.8 Credits)

Module 3 Clinical Trial Conduct, Compliance & Quality Assurance (8.5 Credits)

Module 4 Pharmacovigilance (12.5 Credits)

Module 5 Clinical Data Management & Analysis (8.5 Credits)

Module 6 Clinical Research Management & Leadership Skills (3.7 Credits)

Examination conducted after each module as a part of the student evaluation process.

Evaluation

At the end of every module, a written test will be administered to the students. In addition, the exercises and assignments submitted during the course will be evaluated and discussed with the individuals during every module. Evaluations and grading will be made based on objective and subjective written tests at the end of each module and the final presentation made by every student, judged for its content & delivery by the core committee.

Course Format

The course will be taught via lectures, discussions, group assignments, case studies, workshops and online seminars conducted by prominent industry professionals. These include national and international faculty with 5-10 years of hands-on clinical research industry experience, who currently work in senior positions in multinational pharmaceuticals or contract research organizations.

The Course Content Has Been Designed To Cover The Requirements Of a Diploma Such That a Minimum Of 80 Credits (For Theory, 1 Credit = 15 Contact Hours) (For Internship 1 Credit = 30 Hours) Has To Be Completed By Each Student:

24 weekend lectures (Saturday- 2 hrs, Sunday- 6 hrs): 13 credits

Home assignments and assessments (20 hrs per week): 51 credits over 24 weeks

4-month industry internship program or in-house project: 16 credits

Students enrolling in the PG diploma program are required to complete all the above-mentioned components. However, for industry participants, the modules are offered as stand-alone courses and a certificate will be provided for the specific modules for which the participant has registered.

Internship/Placement

All diploma students will be recommended for internship positions to the industry once the lectures and evaluations have been completed and will also be assisted with job placements at the end of their course.

Course Timings & Duration

Saturday: 6.00 pm -8.00 pm hrs

Sunday: 09.30 am -04.30 pm hrs

Internship: Monday to Friday /Saturday (as applicable)

(After completion of the course)

Total Course Duration: 24 weeks of teaching + 16 weeks of internship

Fees

Total Course Fees: Rs. 1,53,000/-

This includes tuition fees, course materials & handouts, videoconferencing (as applicable), lecture room facilities, service tax and processing fees.

The fees may be paid in 2 installments: Rs. 80,000/- at the time of admission (May-Jun 2026) and Rs. 73,000/- in the month of October 2026.

Clinical Research Office, St. Xavier’s College, 5, Mahapalika Marg, Mumbai, 400001.

Admissions Team: 022-22620662 Ext.22 / 8369919288 or Email: clinical.research@xaviers.edu

Dr. Priya Sundarajan – Head of Department, Department of Life Sciences. hod.lifescience@xaviers.edu

PG Diploma in Clinical Research