Wednesday, 30 April 2014

Medical Writing Industry: A Promising Future

Indian Pharmaceutical industry has moved a long way from an infancy industry to a much prized industry since the time Pharmaceutical industry started delegating various responsibilities to the contract research organizations. Pharmaceutical companies fundamentally spend millions of dollars in order to bring an effective molecule to the market, hence it is imperative to assign the duties to CRO thus making the Pharma industry more economical, organized and competent.

The various duties which are delegated to the CRO by pharmaceutical companies are - performing site management, clinical trial analysis, monitoring, clinical data management, pharmacovigilance and medical writing.

Medical writing service is one of the services that has shown tremendous growth over the past years. Demand for medical writing service is rising at a time when major pharmaceuticals have cut jobs.

Medical writing is the process that translates the work of research of Health Care Practitioner or Scientist into a written content.

Medical Writing is of two types:

 Sl. No.

Regulatory Writing

Scientific Writing


Regulatory medical writing means creating the documentation that regulatory agencies require in the approval process for drugs, devices and biologics.

Educational medical writing means writing documents about drugs, devices and biologics for general audiences, and for specific audiences such as health care professionals


Regulatory documents can be huge and are formulaic.

Concise and simple


They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and CTD

These include sales literature for newly launched drugs, data presentations for medical conferences, medical journal articles for nurses, physicians and pharmacists, and programs and enduring materials for continuing education (CE) or continuing medical education (CME).

Why Medical Writing?

As long as regulatory authorities continue to require an increasing amount of documentation as part of the drug approval process, industry experts believe the demand for medical writing will continue to grow.

The characteristics of a medical writer are-

*      Scientific Knowledge
*      Ideas
*      Represent data in its best presentation
*      Distinguish good science and bad science
*      Organize information


Both Health Science and Life Science   Graduates

Employers and clients for scientific medical writers-

•         Academic medical centers
•         Associations
•         Contract research organizations
•         Foundations
•         Hospitals/Health care systems
•         Managed care organizations
•         Medical advertising/communication agencies
•         Medical education companies
•         Pharmaceutical companies
•         Publishers
•         Web sites


The biggest challenges medical writing industry faces are:


Plagiarism remains an ongoing moral and ethical concern in the medical communications industry, specifically, the World Association of Medical Editors (WAME) defines plagiarism as -

“…the use of others’ published and unpublished ideas or words…without attribution or permission, and presenting them as new and original rather than derived from an existing source

There are two ways through which we can restrain plagiarism are-
  • ·         Peer Review
  • ·         Software

Lack of skills in this area has even been identified as the cause of 
failed mergers
Lack of cross cultural communication
Stringent Regulatory approval Process

Even though Clinical research industry has gone through numerous rise and fall and amendments during recent years nevertheless the industry is working endlessly to improve the standards of regulations and guidelines in India.

A recent market analysis by Center Watch concluded that the market for medical writing had doubled in five years, from 345 million dollars to approximately 700 million dollars. With the continuing difficulties of the economy, it’s hard to find a field that has enjoyed this kind of growth.

Site jobs would have cut off but the CRO industry is still thriving because of pool of talented people, English speaking people and strong IT sector .The result of which the multinational companies are contracting the Indian CRO Companies to achieve the task in economical and timely manner.

ACRI offers Post Graduate Diploma course in Clinical research and  Medical Writing which would benefit students to be partaker of Clinical research industry and also at the same time it would provide an opportunity to the candidates to develop their skills and also implement the expertise by working in various kinds of medical writing project.

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