POST GRADUATE DIPLOMA IN CLINICAL RESEARCH

The term clinical research refers to the entire spectrum of activities involving human subjects within the process of drug development. The foundation of clinical research is the determination of the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use that may be used for prevention, treatment, diagnosis or for relief of symptoms in any disease.


What is a Clinical Trial?

Clinical trials are systematic investigations in human subjects intended to gather safety and efficacy data of a new drug. The clinical trials conducted all over the world follow universally accepted guidelines and regulations. These trials for new drugs are conducted on human subjects or patients only after abundant satisfactory information has been collected on its quality and safety through pre-clinical or animal studies and which have an approval from the required health and ethical authorities.


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

Clinical research activities in Asia have seen a tremendous growth, as predicted by several companies such as McKinsey & Co. According to a recent article published by Frost & Sullivan, India, the current outsourced clinical trial activity in India is at around Rs. 3.5 billion (about US $ 75 million) and is estimated to go up to Rs.13.2 billion (about US $ 281 million) by 2010.

However, what has not been predicted and addressed adequately is the fact that the increasing number of companies engaging in clinical research has given rise to a huge demand for trained clinical research professionals. In response to interactions with industry personnel, we understand that the need of the hour is a clinical research course that produces quality professionals. The St. Xavier’s College Diploma in Clinical Research aims to achieve this by implementing a carefully designed curriculum, run by experienced faculty from the industry, exposure to practical aspects of clinical research and more importantly, selecting students who are high-potential candidates with necessary competencies for excelling in this industry.


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 run a clinical research course that produces quality professionals by implementing a carefully designed curriculum run by experienced faculty from the industry, with exposure to practical aspects of clinical research and by selecting students who are high-potential candidates with necessary competencies for excelling in this industry”

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 120 credits (1 credit = 10 contact hours) has to be completed by each student:

  • 28 weekend lectures (Saturday- 4 hrs, Sunday-6 hrs): 24 credits
  • Home assignments and assessments (10 hrs per week): 24 credits over 28 weeks
  • 4-month industry internship program or in-house project: 64 credits


For students enrolling for the complete diploma, all the above-mentioned components will need to be completed. 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.

Course Timings & Duration:

Saturday: 14.00-18.30 hrs


Sunday: 09.00-15.30 hrs


Internship: Monday to Friday /Saturday (as applicable)

(After completion of the course)


Total Course Duration: 28 weeks (480 hrs) of teaching + 16 weeks of internship

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 – An Overview; Ethics, Guidelines and Regulations (11 credits)


Module 2: Clinical Trial Planning and Design (9 credits)


Module 3: Clinical Trial Conduct, Compliance and Quality Assurance (9 credits)


Module 4: Pharmacovigilance (4 credits)


Module 5: Data Analysis & Management in Clinical Research (Theory + Practicals)


Module 6: Clinical Research Management and Interpersonal Skills (5 credits)


Examination conducted after each Module as a Part of Student evaluation process.

 Course Fees: 

Total Course Fees: Rs. 1,32,000/-


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


The fees may be paid in 2 installments: Rs. 72,000/- at the time of admission and Rs. 60,000/- in the month of December 2022.

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.

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.

Contact Us

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


Admissions Team:  +91 8779649915 or Email: clinical.research@xaviers.edu

ADMISSION

Course Schedule:

Last Date for submitting applications: 15 Sep 2022

Screening interviews of applicants: 1 June 2022 Onwards

Payment of fees: After Admission Confirmation

Lectures will commence from August 2022.



Course Schedule:

Request for Admission form by clicking on the link below


The selection of students will be based on an interview.  Selected candidates would be informed by email and would have to pay the above fee by NEFT in the name of The Bombay St. Xavier’s College Society (account details will be provided by email to students that are selected). The fee may be paid in 2 installments of Rs. 72,000/- at the time of admission and the balance in the month of December 2022.

Director’s Talk

Can clinical research be taught in a classroom? We had always wondered, especially since most of us early entrants into the industry learnt all that we needed and more while on the job. However, this perception and the industry needs have changed significantly over the years. Partly because the course of the clinical research industry in India is no longer solely influenced by a few big pharma companies and there are many players now that play an active role in shaping this industry. As a result, not all companies conducting clinical trials in India have a well-structured training and orientation program for new hires and this creates a need in the industry for trained personnel. It is this very need that we at the St. Xavier’s college diploma in clinical research are striving to fulfill.


Our approach is to provide our students the basic concepts and the necessary practical exposure to the clinical research so that you’re as job-ready as possible at the end of the course. We achieve this by designing a very practical curriculum, drawing from our own experience of 10 years of working in this industry, by employing discussion-based teaching methods like field visits, case-studies and debates, and by having faculty who are from the industry itself.


Is this course the right one for you?


It is very important that all of you, before you apply for this course, think over this question very carefully. One of the key differentiators in this course is that we’re very particular about choosing students who will ultimately do well in the industry and not just in the academic requirements of the course. We look for individuals who have a combination of research orientation and organizational skills, who can communicate effectively, can conduct themselves well in the corporate as well as academic environment and have excellent interpersonal skills. We also look for students who are committed to building a career in this field and are not just doing this course as a stop-gap arrangement. If you have these attributes and the necessary academic qualifications, please do apply for this course. At any time, please feel free to approach us and discuss your career prospects and your suitability for a career in clinical research. We would prefer that you make the right choice rather than enroll in a course or take up a career that doesn’t suit you.


Good Luck!


Dr. Aamir Shaikh, Course Director

PLACEMENTS

The St. Xavier’s college diploma in clinical research has had a fairly good track record in securing placements for their students in the past year.  Our ex-students now work in the following companies/institutions in roles of Clinical Trial Assistants, Clinical Research Coordinators, Data Managers and Clinical Research Associates:


o  Novartis India Limited

o  Pfizer India Limited

o  Johnson & Johnson Pharmaceutical Research & Development

o  GlaxoSmithKline Pharmaceuticals Ltd.

o  Bristol-Myers Squibb India Pvt. Ltd.

o  OncoRx Pharma Pvt. Ltd.

o  Quintiles India

o  Cognizant Technologies

o  Theraverity

o  Jaslok Hospital & Research Centre

o  KEM Hospital

o Sanofi Aventis

o TCS

o Hinduja Hospital

o Lilavati Hospital & Research Center

o Bhatia Hopsital

o NY Vasta Global


However, securing job placement for all students is not a commitment that the course undertakes as getting a job, and more importantly, getting the right job has a lot to do with the opportunities available in the job market, the profile of the candidate and what specifically the employers are looking for. As a part of diploma, all students will be recommended for internship positions to the industry once the lectures and evaluations have been completed or even during the course if the opportunity arises and will additionally be assisted with job placements at the end of their course. On several occasions, the students have the opportunity of directly entering employment, in which case, the first four months of their employment are considered as internship to meet the credit hours for completing the diploma.

F.A.Q.

1. What is the duration of the course?
Ans. The duration of the course is one year. This is divided into 06 months teaching and 04 months work experience/project.


2. What is the process of admissions?
Ans. Once you complete the google form above, we will get in touch with you and schedule an interview (telephonic). Post interview, you would have to pay the fees as listed below to complete admissions. 


3. What is the Course affiliation?
Ans. The course is affiliated with the Department of Life Sciences and Biochemistry, St. Xavier’s College Mumbai.


4. What is the minimum qualification required for the course?
Ans. The applicant should either:
            a. have completed bachelor’s degree in any biological science/ bachelor’s degree in psychology
            b. be in the last year of their bachelor’s degree in any biological science/ bachelor’s degree in psychology
            c. appearing for the last semester of their bachelor’s degree in any biological science/ bachelor’s degree in psychology


5. Will the course be held at St. Xavier’s College?
Ans. In interest of student health and safety during the COVID-19 pandemic the 2022 batch will be conducted online.


6. What are the course fees?
Ans. The total fees for the whole course is INR 1,32,000/-.


7. Does the course have guaranteed placement?
Ans. No. The course does not have a guaranteed placements. However, the course does have placement assistance (based on the performance of the student, attendance and interaction during classes)


8. Will I be provided with study materials when I join the course?
Ans. The student, once admitted, will be provided access to all course materials including lecture presentations, reading materials and other course paraphernalia in electronic form. 


9. How are the fees to be paid?
Ans. Please find the details by clicking here.