Medical writing is one of the fast developing discipline which involves the writing of scientific documents for the medical fraternity and drug development by skilled writers. Medical writing services are gaining momentum as the pharmaceutical companies are looking for more efficient and faster ways to bring new drugs to the market. Good medical writing leads to quality clinical trial conduct, clear trial objectives, optimal product labeling, which allows successful product promotion and systematic conduct of clinical trials. None of these is possible with unclear and poorly written documents. Moreover, the regulations are becoming more stringent, and the need for appropriate documentation of the safety and efficacy of new molecules is required. Good medical writing is essential for obtaining regulatory approvals for the conduct of new clinical trials or marketing of the new drugs after successful completion of the clinical development phases.
Medical writing in the pharmaceutical industry is classified into regulatory writing and medico-marketing writing. Regulatory writing involves creating the documents required for the regulatory approval of new drugs, medical devices and biological substances. These documents include writing of clinical study protocols, study reports, patient informed consent forms, investigator brochures and summary documents. On the other hand, medico- marketing writing focuses on the documents that advertise drugs and explain their benefits to physicians, pharmacists and consumers. These include sales literature for newly launched drugs, data presentation, medical journals etc. Medico marketing writing is generally more patient centric and because the documents are written for general public they are written in as simple language as possible. A good medical writer in the pharmaceutical industry must have the ability to shift from regulatory writing to medico-marketing writing at will, yet maintaining the quality of the written documents.