What is Medical Writing?
To control the cost of the drug and to enhance the drug development, pharmaceutical companies are under pressure as there is change in the market dynamics. Medical writing is a review method and an area in the pharmaceutical industry’s operations, that contains a quality amount of documentation. Medical writing is the development and production of digital documents specifically dealing with medicine.
Medical writing is a well-structured scientific document that consists of health magazines, documents of clinical research, healthcare websites content, health news and journals. It also contains research to improve health. It’s on demand as it conveys new information to the health care centres as well as to the people.
Medical Writing Types:
There are two types involved in medical writing:
- Regulatory Medical Writing:
This form of writing involves getting approval for the drugs, cosmetics and food products. These documents need high standards of technical writing that includes clinical study protocols, clinical study reports, investigator brochures and Common Technical Document. These documents summarise the data for developing pharmaceutical or cosmetic products. They will document the right information clearly to the ethical committees and regulatory authorities.
- Educational Medical Writing:
From various resources information will be collected and made into documents and will be handed over to the healthcare professionals and to the general audience. These documents will be written in simple, non – technical language for newly launched drugs, data interpretations that can be used for medical conferences and medical journal articles for nurses, pharmacists, consumer educational programs and so on.
Role of Medical Writer in Clinical Research
Medical writers play a huge role in clinical research in handling a variety of documents that contain drug development and its results. They convert large quantities of clinical data produced during clinical trials into understandable documents to the relevant regulatory authorities. They also clearly and effectively describe the result of the clinical research, usage of products and other medical related information.
Few spectrum of documents created by Medical Writer
- Protocol writing: A detailed document depicting the guidelines for conducting the clinical trial and it contains the study objectives, methods and statistical data.
- Investigator’s brochure: Document that outlines the entire clinical process to the investigator
- Clinical Study Reports: Describe the methodology followed and the results obtained in a clinical trial.
- New drug application: Documents that need to be submitted to FDA for approval of selling and marketing a new drug. NDA contains full information on safety, efficacy, benefits and risks.
The main aim of the Clinical research institutes is to advertise their newly launched products and prepare materials for identifying the products, and handle a variety of documents that involve reports of drug development. Medical writers play a crucial role in enabling these processes. They understand the drug or medical device development process and develop accurate documents and regulatory requirements.