Medical writing

{ Posted on 8:51 AM by V.C.Dave }

Medical writing is a new fast developing discipline in world, which involves writing on topics useful for the medical fraternity, drug development for companies, informative materials for general publics and student synopsis and thesis. The role of medical writer is different in different industry like in the pharmaceutical industry, medical writers work in two broad areas: regulatory writing and marketing material writing; for magazine and web content medical writers write on informative issues for making awareness to general public and new filed the synopsis and thesis write up for medical students, post graduate medical students, researchers in medical science and searching topics for research.


Regulatory writing or industry is an integral part of drug development and the approval process. It covers writing on:


Protocols
Investigator’s brochures
Interim and final clinical study reports
Periodic safety update reports
Serious adverse event reporting
Investigational new drug applications
Common technical documents
Food and Drug Administration (FDA) briefing documents
Integrated summaries of efficacy and safety, manuscripts
Abstracts
Posters
Product labeling using terminologies standardized by regulatory and international agencies
And many more………


The quality of documents submitted for regulatory approval plays a significant role in the success or failure of new products, inventions and devices.


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In marketing area, the medical writers make documents that advertise drugs and have complete explanations on the benefits to physicians, pharmacists and consumers. A lot of literature needs to be developed to support the product and issues unique to the company keeping in mind the local and international regulatory guidelines. There is a growing need for health care information and appropriate compilation of product literature is expected to result in an increased consumer interest in the brand as well as the organization.


In magazine and development of informative material is also growing market for medical writers. Here the medical writers develop the content on simple and message transmitting way. It is like FAQ (frequently ask questions and answer). It is ongoing process for government agencies and information broadcasting agencies. There lots of health related magazines and television media are coming in india and world. They need the stories and news for their readers and viewers. Here the medical writer should creative and innovative for development of content.


The number of researchers and medical students are increased in last few years. Also the regulator bodies like MCI in India and other countries are demanding research from their students and academicians. In this scenario the students and researchers are in search of good research topics and even synopsis for research project. In this area the medical writer can help the researchers to find topics, write synopsis for proposal to ethics committee, budget for project, results and report write up. Even now day students can send their data for statistical analysis and interpretation and thesis write up.





Why Outsourcing?


Pharmaceutical companies are now opting to outsource in order to meet deadlines, maintain high quality and/ or reduce the cost. Outsourcing to companies that have staff with medical background and technical knowledge of the regulations increases the speed of work. The demand for high quality documents is also increasing as the difference between poor-quality and high-quality medical writing can mean the difference between a speedy drug submission and approval, and a rejection.


More companies are opting to outsource medical writing so that they can obtain quality services in a cost effective manner.


High mobilization rate in the pharmaceutical industry poses a big challenge to the development and maintenance of a medical writing department in huge pharmaceutical companies. Further, the bulk of medical writing tends to be piled towards the beginning or the end of the clinical studies, whereas in between medical writing department tends to have idle staff waiting for work. Company-employed medical writers have a propensity to share insular views that companies have regarding their own products. On the other hand, by outsourcing, these companies get an added advantage of the range of experience and unbiased attitude that freelance writers can provide. We are providing this quality write up for pharmaceutical companies also.


In media and broadcasting side also the similar issue, they can afford the full time staff for specially medical and health field. They are getting stories from the outsource companies. As we are working and providing quality medical write up to our clients. We have full team who can write latest updated stories for media and magazine for India, South Asia and World.


For students research and postgraduate studies we are specially master for selection of topics, synopsis write up, protocol; write up, statistical analysis, interpretation and thesis write up. Any research student, PhD students, Postgraduate medical students or medical student can avail our services.


Please contact for further query on informationmbbs@gmail.com

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