Advanced PG Diploma in Clinical Research & Medical Writing

Key Facts

Duration
12 Months
Max. Duration
24 Months
Mode
Online
CREDITS
60 ECTS

Overview

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 a recent 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.

Overview

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

The program is comprised of 28 modules that can be completed in about 6 to 8 months. For a detailed list of modules covered in this program, please refer to the curriculum.

See Curriculum

Curriculum

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: 60

What is a credit?

A credit represents the amount of effort that is required to complete the program. Each module credit is equal to approximately 20 hours of study including lecture, tutorial, projects, assignment, field work etc. as may be applicable.

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.

How You Will Study

This program is conducted fully online.

Once you are enrolled you will be provided a username and password to login to our e-Campus. All the courses that you are supposed to study will be available in your account. You can log in and complete your courses at any time of your convenience. Study materials are provided in the form of lectures, reading materials, additional videos, research papers, and so on. The faculty can be contacted for any assistance when required. All tests and assignment submissions also take place via the e-Campus. For more information please refer to the online learning section of the website.

Important Dates

Next Start Date: 15 Aug 2022
Application Deadline: 12 Aug 2022

Assessments

  • Multiple Choice Questions

    Each lesson that you study online will be followed by a multiple choice question test. These usually comprise of 15 to 20 questions and can be attempted multiple times if needed. Pass percentage is 60%. The next unit in the sequence only unlocks once you have passed the test.

  • Project Work

    Each module is followed by a project or an assignment. This is like writing an essay in 1000 to 1500 words. The project topic and the guidelines to be followed will be available in your account.

Academic Support

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 can be contacted via personal messaging, emails, or phone, if required.

Towards the end of the program you will be provided placement assistance via our “Student Success Team”.

In addition, soon after enrolment, each participant registered in this 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 for career guidance.

Eligibility Requirements

The minimum eligibility criteria for this program 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, 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 this field. Please contact our admission representatives / counsellor to discuss your case.

Document Requirements
  • A passport size photo (head and shoulders only)
  • Copy of identity proof e.g. a copy of passport or any other government-issued identity card
  • Copy of bachelor’s degree or equivalent (degree/higher national diploma etc.)
  • Copy of academic transcripts/marks sheets from the bachelor’s degree
Language Requirements

This program is taught in English. Therefore, you should be comfortable in using English as a language of communication (reading, writing and speaking).

No proof is required.

 

How much does it cost?

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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.

Program FAQ's

This program can be completed in about 12 months. It is fully self-paced, so you can increase your pace or go slow based on your time availability.

The primary mode of learning is via pre-recorded lectures, videos, reading materials etc. A few live guest lectures are scheduled during the program however they are optional to attend. Whenever such sessions are scheduled they are planned in a way that is convenient for most of our students. If you are unable to attend, a reccorded version will be provided.

You will be able to interact with the faculty via the personal messaging facility available in your study account, discussion forum, or via emails. A short phone call can also be scheduled if necessary.

A discussion group is available for the program. You can post your questions in the group and other students may respond.

Generally, you do not need to purchase any books. All the resources that you need will be made available by the faculty in your account. If you do wish to have text books, then the faculty can recommend to you some, and you may purchase them on your own,

Each unit within each course will be followed by a short multiple-choice question test. Once you pass, the next unit will activate for you to study. You can take these tests as many times as you need to.

In addition, you will be required to submit assignments for each course. Assignments are like essay or paper writing, usually of 1000 – 1500 words. Guidelines on how to write them will be available in your account.

You can save the pdf study notes that will be provided for each unit. Videos and other multimedia content cannot be downloaded.

No, our degree does not mention that the program was conducted online.

At this time any graduation ceremony is not conducted for short duration programs like this one. Completion documents are sent to you by post or courier.

We recommend that you invest 10 to 15 hours per week in order to be able to complete within the prescribed program duration.

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