Clinical Development Sciences

PROGRAM DURATION

6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10-15 hours/week

Post Graduate Diploma in Clinical Research

This clinical research training course provides you with a thorough understanding of all important and relevant knowledge areas of drug development and clinical research management.

TOTAL CREDITS: 22

Next Commencement Date

01 MAY

2019

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INTRODUCTION

Why study this program?


Introduction

The pharmaceutical and biotech industry is experiencing a sea change worldwide with more impetus on innovation and personalized medicine. The business models are maturing to the next level of niche busters and towards a coexistence of novel and the age old blockbuster strategies.
With the economic drift and emerging economies like India, China, Brazil and Russia, the pharmaceutical and biotech industry is shifting research and development towards these regions especially in the phases of clinical development.
Further, indigenous pharmaceutical and biotech companies in these regions are increasing their R&D efforts both for innovative molecules as well as the generic market.


Consequent to this scenario, a large number of clinical research management organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management, clinical research consultancies, KPOs etc. This has created a demand for skilled workforce in the clinical research industry as stressed in many business reports.

James Lind Institute, through a variety of high quality clinical research training courses,is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise.

The Post-Graduate Diploma in Clinical Research (PGDCR) Course will provide you with an in-depth understanding of the core areas of the clinical research process and enhance your skills and knowledge to the level expected of a Clinical Research Associate / Professional. The Post-Graduate Diploma in Clinical Research (PGDCR) Course curriculum is fully reviewed and endorsed by the Clinical Research Industry and the academia thus imparting students the edge that they require to make an entrance in the clinical research industry. It also empowers the professionals working in the clinical research industry with the skills and knowledge to move to higher cadres in the management hierarchy.

PROGRAM STRUCTURE

What will be taught?


Program Structure

MODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 14: MEDICAL DEVICE TRIALS
MODULE 15: PROJECT AND VENDOR MANAGEMENT
MODULE 16: FINANCIAL MANAGEMENT OF CLINICAL TRIALS
MODULE 17: PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

TOTAL CREDITS: 22

MODE OF STUDY: ONLINE

The curriculum for the program - Post Graduate Diploma in Clinical Research (PGDCR) is extensive, has been developed and evaluated by experienced industry professionals and is fully endorsed by the clinical research industry. Not only is this program suitable for new graduates but also for working professionals who either wish to grow further in their clinical research career, or those who wish to make a move to the clinical research industry from any other related sector.

ASSESSMENT

How will I be assessed?


Assessment

Course assessment involves online multiple choice questions for each lecture, followed by assignments for each study module.


Overall academic performance in the program is measured on a 4 point Cumulative Grade Point Average (CGPA) scale. More information about this is available here: Evaluation System

ELIGIBILITY

Am I eligible?


Eligibility

The minimum eligibility criteria for Post-Graduate Diploma in Clinical Research Course (PGDCR) would include either of the following:

- Any degree in Bioscience/Life Sciences such as Biochemistry, Microbiology, Genetics, Biotechnology, Botany, Zoology etc
- Any degree in Medicine such as MBBS, BDS, BPT, BAMS, BHMS, BUMS etc
- Any degree in Pharmacy / Pharmaceutical Sciences
- Any degree in Chemistry / Biostatistics / Bioinformatics
- Any degree in Nursing / Allied Health.
- Students in their final year of graduation for the above courses are also eligible to apply.

If you lack the above mentioned educational prerequisite you may still be eligible to apply upon recommendation of your supervisor if you have some prior work experience in clinical research / allied areas. Please contact our admission representatives / counsellor to discuss your case.

ACADEMIC SUPPORT

What support will I receive?


Academic Support

Throughout the course, the students can interact with the faculty and other students via the e-Campus to discuss any coursework related issues.


Each student enrolled in the Post-Graduate Diploma in Clinical Research Course (PGDCR) is also assigned a mentor throughout the course who will be a senior professional from the industry. Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.

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Program Fee

How much will it cost?
Please use our online fee calculator to calculate the fee applicable to you.



CAREER OPPORTUNITIES

This postgraduate diploma program in clinical research can help you explore careers in multiple domains related to clinical research. You can find employment with pharmaceutical companies, contract research organizations, biotechnology companies, research institutions among many others.


Expert Opinion

"Clinical research industry is growing at a rapid pace with an increasing investigator base and a developed regulatory infrastructure. Online clinical research courses provided by James Lind Institute will surely benefit students who want to make a career in clinical research. The clinical research courses are delivered through an effective online portal and are conceptually designed to meet the needs of the clinical research industry."
Dr. Sujit Arun Chandratreya MD, DM, DNB (Endocrinology),
Senior Clinical Research Investigator


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