Clinical Development Sciences
PROGRAM DURATION
6 - 8 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week
Advanced PG Diploma in Clinical Research & Medical Writing
In addition to clinical research this advanced medical writing training program trains you to write documents such as medical case reports, clinical trial reports, study protocols, and various other regulatory and medico-marketing documents.
TOTAL CREDITS: 32
INTRODUCTION
Why study this program?
Introduction
Medical writing is a fast developing and exciting discipline that involves writing topics helpful for the medical fraternity and drug development. Two major areas in the pharmaceutical and biotech industry with a large demand for skilled medical writers are regulatory writing and marketing material writing.
The pharmaceutical and biotech research industry has advanced in all domains from basic research to bed side research. Medical writing is a dominant profession involved in all stages of product development in the pharmaceutical and biotech industry having a significant role in the success or failure of new products, inventions and devices.
According to the 2008 Centre Watch market research analysis, the medical writing market has grown at the rate of 15% annually for the last five years to nearly $700 million. This exponential rise has been attributed to the amount of work outsourced by drug sponsors in order to meet the regulatory requirements, and to also convert clinical study data into manuscripts for scientific and medical publications.
Medical writers are an integral part of the drug development process and handle a wide range of responsibilities. Professionals with medical writing skills work in the pharma-biotech and clinical research industry, healthcare organizations, media or as freelance entrepreneurs.
In the wider clinical research industry, 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 and drug safety, 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 is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise.
The Advanced Post-Graduate Diploma in Clinical Research and Medical Writing (APGDCR-MW) course will provide you with a methodical understanding of the core areas of clinical research and medical writing thus enhancing your skills and knowledge to the level expected of a Clinical Research Professional and Medical Writer. It imparts rigorous medical writing training to develop professional expertise of high caliber.
The Advanced Post-Graduate Diploma in Clinical Research and Medical Writing (APGDCR-MW) 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 required to move to higher cadres of 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
MODULE 18: BASICS OF GOOD MEDICAL WRITING
MODULE 19: COMPUTER SKILLS
MODULE 20: OVERVIEW OF THE REGULATORY, MARKETING AND DRUG PROMOTION PROCESSES
MODULE 21: COMMON TECHNICAL DOCUMENT
MODULE 22: PROTOCOL, INVESTIGATOR’s BROCHURE & CASE REPORT FORMS
MODULE 23: CLINICAL STUDY REPORT
MODULE 24: SENTENCE CONTROL
MODULE 25: WRITING FLOW AND COHESIVENESS
MODULE 26: PUBLICATION WRITING
MODULE 27: DOCUMENTS IN MEDICO-MARKETING
MODULE 28: MANAGING THE REVIEW PROCESS
TOTAL CREDITS: 32
MODE OF STUDY: ONLINE
The curriculum for the program - Advanced Post Graduate Diploma in Clinical Research & Medical Writing (APGDCR-MW) 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 and/or medical writing career, or those who wish to make a move to the clinical research or medical writing sector from any other related industry.
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 Advanced Post-Graduate Diploma in Clinical Research & Medical Writing (APGDCR-MW) 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.
Candidates without any science background such as graduates in English language or candidates with some work experience in writing / clinical research / allied areas may also be eligible for this program. Please check with our counsellors for more information.
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 Advanced Post-Graduate Diploma in Clinical Research & Medical Writing Course (APGDCR-MW) 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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CAREER OPPORTUNITIES
This combination program of clinical research & medical writing is a unique program that opens up a number of career opportunities in the area of core clinical research as well as medical / scientific writing. Positions that can be explored include Clinical Research Associate, Clinical Research Coordinator, Site Monitor, Clinical Trial Manager etc. As a medical writer you can also explore multiple career opportunities with pharmaceutical companies, contract research organizations, medical communications companies, healthcare websites, journals, magazines etc. In addition to working as a full time writer you can also explore freelance medical writing opportunities.
MORE INSIGHT
"Medical writing is an excellent career option for people who have a flare for writing. The career is very rewarding. People who demonstrate good people management skills also have an opportunity to grow higher up in the corporate ladder and work in senior positions managing large teams of writers and whole departments."
