Course - Post Graduate Diploma in Clinical Research and Medical Writing

COURSES

JLI students get the opportunity of reading, listening to lectures, additional reference readings, exercises and assignments, as many times as they may need during the course to attain maximum understanding of the subject. This training is substantiated by a prompt query resolution support by well learned faculty from the industry. This kind of personalized training approach in clinical research and medical writing takes away the constraints of distractions, missed classes, fatigue and sometimes-unbearable ennui seen in regular classrooms.

Advanced Post-Graduate Diploma in Clinical Research
and Medical Writing

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.

Course Structure

CLINICAL RESEARCH

MODULE 1 GENERAL INTRODUCTION
MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
MODULE 3 PHARMACEUTICAL MEDICINE
MODULE 4 THERAPEUTIC AREAS
MODULE 5 ETHICS IN CLINICAL RESEARCH
MODULE 6 ROLES AND RESPONSIBILITIES
MODULE 7 CLINICAL TRIAL PREPARATION
MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 9 STUDY START-UP
MODULE 10 CLINICAL TRIALS MONITORING
MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
MODULE 12 COMPLIANCE AND AUDITS
MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
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

MEDICAL AND SCIENTIFIC CONTENT WRITING

MODULE 1 Basics of Good Medical Writing
MODULE 2 Computer Skills
MODULE 3 Overview of the Regulatory, Marketing, and Drug Promotion Processes
MODULE 4 Clinical Study Report
MODULE 5 Sentence Control
MODULE 6 Writing Flow and Cohesiveness
MODULE 7 Publication Writing
MODULE 8 Documents in Medico-marketing
MODULE 9 Managing the Review Process

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional and Medical Writer in different capacities.

Course duration

Self Paced 8 - 10 months

A student enrolled in the Advanced Post-Graduate Diploma in Clinical Research & Medical Writing (APGDCR-MW) course is expected to study online for a minimum of fifteen hours per week.

Course Assessment

Course assessment involves online MCQs for each lecture, followed by assignments and numerous assessments by tutors throughout the course in the “Online Campus Tutoring Centre” by the method of interactive discussion.

Eligibility Criteria

Minimum eligibility criteria for the course would be either of the following:

MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.
Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.
Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).
Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.
Graduate or equivalent degree in Nursing/Allied Health.
Students in their final year of graduation for the above courses may also apply.

Fee Structure

Course fee for Advanced Post-Graduate Diploma in Clinical Research & Medical Writing (APGDCR-MW) for 2010-2011 is INR 22,500.
For more details about admissions click here.

Academic Support

Each student in the Advanced Post-Graduate Diploma in Clinical Research and Medical Writing (APGDCR-MW) course is assigned a mentor throughout the course who will be a senior professional from the Industry. Students are in close contact with the “Student Success Team” during the course and thereafter as alumni. To know more about the “Student Success Team”, click here.

Our unique academic approach in clinical research and medical writing training provides enrolled students with a tutoring advisor/mentor. The tutor is also a member of the "Students Success Team" who mentors students for all round professional development throughout the course. Tutors form an invaluable resource for the students bringing them in an interface with the clinical research industry.