6 Months (Self Paced)
Maximum Allowed Duration: 18 Months
Expected Effort: 10-15 hours/week
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 Start Date
Why study this program?
The drug and medical device development industry is experiencing a tremendous change globally. This change has geared momentum towards development of unique, newer and safer therapies and towards personalized medicinal drugs. The business models are advancing to the higher levels of niche busters and towards a coexistence of newer and blockbuster therapies used in the past.
Due to the strengthening of economies in the BRIC countries i.e. Brazil, Russia, India & China, drug and device companies are focusing their research and development efforts in these regions particularly the research for clinical development of products i.e. Phase I to Phase IV clinical trials. Further, local pharmaceutical and biotech companies in these regions are also rapidly stepping up their work in Research and Development for developing promising new molecules as well as generics.
With the growth of the industry a number of clinical trial management organizations and business models have come into existence which include full-service Contract Research Organizations (CROs), early phase CROs, Site Management Organizations (SMOs), companies offering fewer but specialized services such as Clinical Data Management, Business Consulting, Knowledge Process Outsourcing (KPOs) etc. This growth has eventually amplified the demand for trained staff in the clinical research industry.
The Post Graduate Diploma in Clinical Research Course equips you with the knowledge and skills required for making a successful career in drug development and clinical trials. The program has been designed in a way so as to compliment your basic education and to provide you a platform to enter the pharmaceutical and biotech industry as a clinical research professional.
What will be taught?
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.
How will I be assessed?
You will be assessed on an ongoing basis by the faculty based on the following criteria:
One is the completion of the online multiple choice question tests that follow each lesson; and second is the timely submission of assignments for each study module within the JLI e-Campus.
Your academic performance in the program will be assessed on a 4 point GPA scale. More details about our evaluation system is available in the following link: Evaluation System
Am I eligible?
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.
What support will I receive?
As a student you can interact online with the faculty members and fellow students to network and to discuss important topics via your e-Campus. The faculty promptly answers all questions related to the study in the Online Campus Tutoring Center (OCTC)
Towards the end of the program you will be provided placement assistance if required and career development support via the “Student Success Team”.
In addition, each participant registered in the Post-Graduate Diploma in Clinical Research Course is provided with a mentor who is an experienced professional from the clinical research industry. The mentor can be contacted at any time via email or phone.
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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.
"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