Dual Certification in Clinical Research and Medical Writing (DCCRMW)

INDUSTRY OVERVIEW

As clinical trials are required to bring new and better drugs into market for various therapeutic areas, Medical Writing plays a major role in the quality and successful outcome of new and better treatments. Medical Writing helps to present trial data in clear and concise fashion. The worth of medical writing market is estimated to US$ 600 million against the clinical research market which accounts for US$ 64 billion.

As large number clinical trials are outsourced to India, the need of medical writers has been in demand in the past few years. The industry in India is experiencing a growth rate of 15 – 20%. Large number of qualified professionals in health sciences and proficiency in English makes a suitable career options for interested candidates from these background.

LEARNING OBJECTIVES

  • Describe the role of the regulatory professional in medical writing and clinical research
  • Identify basic strategies for crafting an effective documents: SOPs, CT Protocol, ICD, CRF, Data Management Plan, Clinical Study Report
  • To provide theoretical knowledge on various essential CR topics: Drug Discovery, Regulatory, GCP, Ethics etc.
  • Outline appropriate guidelines and policies for the medical writer
  • Identify strategies for improving documents quality
  • To train you on different aspects and activities performed during a clinical trial: Informed Consent, SAE Reporting etc.
  • Roles and Responsibilities of CR and Medical Writer along with its application required to execute at various levels.

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Curriculum

Module 1: Clinical Research

  • Introduction to clinical research
  • Ethics in Clinical Research
  • Roles & Responsibilities of Clinical Research Personnel
  • Guidelines & Regulation Associated with Clinical Research
  • Essential Clinical Trial document
  • Importance of Informed Consent Documentation
  • Importance Safety Reporting
  • Recent Trends in Clinical Research
  • Careers in Clinical research
  • Clinical Research Glossary & Common Abbreviation

Module 2: Medical Writing

  • Introduction to Medical Writing
  • Essential Clinical Trial Document
  • Development of standard Operating Procedure
  • Developing Clinical Trial Protocol
  • Developing Informed Consent Document
  • Developing Case report Form
  • Developing Data Management Plan
  • Developing clinical Study Report

Eligibility

  • Pharmacy Students Pursuing or completed): B.Pharm, M.Pharm
  • Life-Sciences Students (Pursuing or completed): B.Sc, M.Sc
  • Medicine Students (Pursuing or completed): BDS, MDS, MBBS. M.D., M.S, MCh
  • Alternative Medicine (Pursuing or completed): Ayurveda, Unani, Yoga, Siddhi, Homeopathy, Traditional Medicine etc.
  • Nursing (Pursuing or completed): B.Sc., M.Sc.
  • Industry Personnel
  • Clinical Research Personnel: CRC, CRA, CTA, Clinical Trial Investigators
  • PhD

Online Enrollment Procedure

Step 1

Click button Enroll Online and then Click Checkout button

Step 2

Complete and submit the Registration Form, followed by Checkout button

Step 3

Choose convenient Mode of Payment and Make the Payment

Step 4

Get Instant Access* to Login Details along with Study Material & Assignment.

*Instant access is applicable only to participant who have selected online mode of learning. For offline (distance) mode of learning, the study material and assignment will be dispatched to their corresponding address on the last date of registration of that batch.



Offline Enrollment Procedure

Step 1

Download the Offline Enrollment Form present on respective pages of courses

Step 2

Send the completed enrollment form along with the fee (details mentioned on enrollment form) on our official address

Step 3

Dispatch of course material along with assignment on your corresponding address.

Course FAQs

What is Medical Writing?

Medical writing an activity that requires special skills to thoroughly understanding of medical and clinical information along with capacity to present data in a clear and concise fashion in a well formatted document set as per guidelines.

What is Clinical Research?

“Clinical research is a branch of medical science that determines the safety & effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use” or “We can say that clinical research is an important part of the drug/device discovery and development to ensure that the drug/device to be marketed is safe and effective on human usage”.

What is the career growth in the industry after completing DCCRMW Training?

The The career growth in the industry is as follows:

Medical Writer >> Sr. Medical Writer >> Team Manager >> Head of Department

What is the career growth in Clinical Research industry after completing DCCRMW Training?

The career growth in CR industry is as follows:

Physicians:Principal Investigator, Co-investigator, Medical Advisor, Drug Developers, Regulatory Affairs Manager and Clinical Research Physician etc. 

Others:Clinical Research Coordinator (CRC)/ Clinical Research Associate (CRA) >> Sr. CRA >> Project Manager >> Team Leader >> Operations Manager >> Director

Why should I pursue this course?

DCCRMW will offer you following inherent advantages to excel your career growth by:

  • providing an in-depth knowledge on essential elements of Medical Writing and Clinical Research
  • increasing the visibility of your CV among potential recruiters
  • Increase the acceptance in companies’ for jobs against non DCCRMW candidates.
  • An opportunity to explore career as Medical Writer, CRA and CRC

Where I can apply after completing DCCRMW course?

After successfully completing DCCRMW course one can join industry as:

Medical Writer with Pharmacovigilance Sponsor Companies (Pharmaceuticals, Biotech, Research), IT companies, CROs, Hospitals, PV Centers, SMOs, KPOs etc.

Clinical Research Associate/ Clinical Research Coordinator (CRC) with Sponsor Companies (Pharmaceuticals/ Biotech), Hospital Sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs), Research Institutions etc.

For more details on courses, fees, enrollment, Result, Assignments, Certificates, Placements visit our General FAQs section.

Course Code : DC-201-03
Level : Beginner
Mode of Learning : Online/ Distance
Registration Status : Open
Examination : Assignment Based
Fee : Rs. 14500
Current Batch : May'16 (Till 31st)
Duration : 24 weeks

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