India is becoming a hub for clinical research; the demand for professionals in this field is growing rapidly. Clinical research business in India will be worth $1 billion by 2010. Thus, there will soon be a massive demand for clinical research professionals, making it an interesting career option with massive growth potential.

1. What is Clinical Research?

1. A clinical research is a scientific study of the effects, risks, efficacy and benefits of a medicinal product.
2. Using the knowledge gained in basic and applied research to conduct research (generally with humans) in treating disease or dysfunction in a new way
3. Study of a drug, biologic, or device in human subjects
4. Medical research to show that a device, drug, or other treatment is safe and effective in humans

2. Who is a Medical Writer?

• The medical writer serves to make sure that the documents comply with any regulatory, journal or other guidelines in terms of content, format and structure
• Medical writing is an established function in the pharmaceutical world, due to the fact that people have begun to recognize that not everyone can write a well-structured document that presents information and tells a message clearly and concisely
• With an increasing demand for getting new drugs to the market as quickly as possible, writing documents that can be read and understood quickly and easily has become an ever higher priority

3. Types of medical writing:

Medical writing can be classified as either Regulatory Medical Writing or Marketing Medical Writing.
A) Regulatory Medical Writing: RMW is writing documents for regulatory agencies so that drugs, devices and biologics are approved, and stay approved for marketing to humans.
Documents should be written for every drug which went through trials and the same should need to submit regualatory agencies.

1. Clinical study protocols
2. Clinical study report (CSRs)
3. Patient informed consent forms (ICFs)
4. Investigator brochures (Ibs/Initial/Final)
5. Investigational New Drug Applications (INDs, Initial INDs, and IND AR)
6. Safety update reports ( CTSURs, ASURs, PSURs)

a) Narrative Writing:

• Responsible to write safety narratives, SAE case narratives

b) Pharmacovigilance:

• Aggregate report writer
• PV Specialist
• SAE case narratives

B) Marketing Medical Writing: MMW is writing documents about drugs, devices and biologics for general audiences,and specific audiences such as professional healthcare audiences.
• Monographs about a newly launched drug for sales representative
• Data presentations (PPTs) at medical congresses
• Medical journal articles for nurses, physicians and pharmacists

4. Document support: Besides writing there are a few subsidary functions that ensure quality, scientific accuracy, meeting client’s standards and regulatory requirements of the written documents
• Document editing- edits the format
• Document Quality check- checks grammar and sentence formation
• Document Technology- prepares final document with good shape
• Data Validation- data entry

5. What is SAS?

The SAS, or Statistical Analysis System, is a collection of software products that is grouped and offered by the SAS Institute.

A) Role of a SAS Programmer:

• Perform statistical programming, design, and analysis for clinical trial projects. Planning, coordinating and providing statistical analyses, summaries and reports of studies is also a part of their job profile.
• In addition they are responsible for New Drug Applications and Biological License Applications submissions

6. How to learn CR & MW skills?

No need to spend lakhs of rupees to get a clinical research degree and to learn medical writing skills. There are some voluntery organizations that will help you in aquiring CR & MW skills.

􀂙 What is IMWA (Indian Medical Writers Association)?

IMWA is the Academy of Medical Writing-India. It supports medical writers, scientific writers and medical/life science students through training and networking opportunities.
IMWA offers professional training for medical and life science professionals through the comprehensive IMWA Certified Development Program. This program offers a broad variety of clinical research and medical writing courses that cover topics including:
Basic writing skills, guidelines specific for the pharmaceutical industry, and accounting for freelancers.

Job seekers:
This website offers access to IMWA's write stuff, articles, as well as access to our resume database and a jobs page advertising vacancies. You can upload your profile at a free of cost

Employers:
In an exciting development, we now also have a company list, in which companies can advertise their services. If you would like more information about how to sign up to the resume database, or how to advertise your job vacancies on this website, please visit http:// indianmedicalwritersassociation.blogspot.com or http://www.imwa.co.in/ (under construction) or contact mailto:amith.imwa@gmail.com

7. Eligibility:

A) For CR, MW & SAS:
Any life science graduate with publications or good writing skills
• PhD degree in life sciences
• MBBS, BDS, MVSc, BVSc
• MSc., in Life Sciences
• Mpharm, Bpharm, BSc Life Sciences

B) For Clinical Research Associates (CRAs)
Any life science/Medical graduate with Clinical Writing skills
C) For SAS Programmers (SAS)
Any life science/Medical graduate with Clinical SAS skills

8. Medical writing organizations

There are several professional organizations for medical writers around the world.
• The European Medical Writers Association (EMWA)
• The American Medical Writers Association (AMWA)
• The Indian Medical Writers Association (IMWA)
• The Australian Medical Writers Association (AuMWA).
• the Drug Information Association (DIA)

The purpose of these organizations is
1. To create a forum where medical writers can meet and share knowledge and experience
2. They serve to promote career opportunities and professional development of medical writers
3. To promote standards of excellence in biomedical communication.
All these organizations offer training in the fundamentals of medical writing.

9. Useful links

The following are good places to get more information on medical writing:
• European Medical Writers Association (EMWA)
• American Medical Writers Association (AMWA)
• Australian Medical Writers Association (AuMWA)
• Medical Writing Network (MWN)
• Toolkit for New Medical Writers
• Indian Medical Writers Association (IMWA)

10. Growth Prospects:

There are various growth opportunities along the way for those willing to learn.
• Doing a masters (pharmacy, life sciences, biochemistry )will enhance the job prospects of a CRA to become a Project Manager.
• Similarly a PhD in a related discipline is needed to become a Medical Director.

11. Why outsourcing to India?

1. India is the second largest pharmaceutical market in Asia growing by more than nine per cent annually.
2. There are more than 50,000 jobs in clinical research in India .
3. Globally, pharmaceutical companies are turning to India in order to tap the medical writing potentials of the country.
4. A large number of qualified and experienced professionals, cost effectiveness and wide use of English are some of the advantages that make India a dream destination for outsourcing medical writing.
5. India has a pool of qualified, talented and experienced medical scientists. India, each year, produces approximately three million graduates, 700,000 post-graduates and 1500 PhDs in the scientific stream. This includes around 18,000 medical graduates passing out from 200 medical schools.
6. Many Indian professionals have thorough knowledge of good clinical practices, drug development, experience with basic and clinical sciences and good writing skills.

12. Writing, SAS, CRA positions at various companies:

Accenture, Chennai & Bangalore
Novartis, Hyderabad
Cognizant, Mumbai
NovoNordisk, Bangalore
Capgemini, Bangalore
Parexel, Hyderabad
Cytel, Pune
Patni, Pune
Clinsys, Gurgaon & Bangalore
Quintiles, Bangalore
gvk-bio, Hyd, Chennai & Gurgaon
Quest, Bangalore
gsk-Bangalore
Reliance, Bangalore & Mumbai
Icon, Chennai
Sanofi-Aventis, Mumbai
Igate, Pune
Satyam, Hyderabad
Indigene, Bangalore
Siro, Mumbai
Infosys, Pune
TCS, Mumbai and Bangalore
I3 Global, Mumbai
Thomson, Hyderabad
Kainapse, Gurgaon
Veeda, Ahmedabad
Manipal Acunova, Bangalore
Wipro, Bangalore
Makro, Hyderabad
Wochard, Mumbai