Scientific medical writing involves writing detailed information about the basic medical sciences, drugs and latest technological innovation in the field of medicine for a range of audiences including medical specialists and health care professionals. This scientific information is written for publication in the medical journals, medical news, and regulatory documents.
The important role of scientific medical content writers is to develop high-quality technical materials for the scientific and medical community and disseminate the critical information regarding latest inventions, discoveries and other significant medical updates in the specialized field of medical science. There is a vast difference between writing a normal article for the general public and developing scientific medical contents. Scientific medical writing necessitates the writer to deal with the development of scientific and clinical documentation procedures and present that critical information in a standardized, authenticated, dependable and credible manner.
Planning and preparation of Clinical Evaluation (CE) Report
The scientific medical writer needs to have a proper understanding of the various stages involved in conducting a prior clinical evaluation for developing technically-rich Clinical Evaluation Report (CER).
MEDDEV (2.7/1) guidelines for CER documentation
describe the various stages of planning, assessment, and evaluation of clinical data about medical a device to validate the clinical safety and functional performance of the concerned medical device.
Some of the important procedures and documents involved in the CER development process include
• Regulatory standards and guidelines
• Standard operating procedures for carrying out Clinical Evaluation
• Quality System related procedures and protocols
• Outlines for Clinical Evaluation Plan (CEP) and Clinical Evaluation Report.
• Pre-market and post-post market CER
• Clinical investigation data
The scientific medical writer needs to conduct a comprehensive literature review to search appropriate literature concerning with the specific device to identify relevant clinical data. The scientific medical writing of medical devices must also provide important details about the mandatory European confirmatory CE marking documentation, which provides the medical device manufacturer’s declaration that the particular device or product meets the specific requirements and directives of concerned authorities.
Language Rules for Scientific Medical Writing
Scientific medical writers must have an in-depth understanding of the various nuances involved in medical writing and must follow important standards in the preparation of superior quality medical contents catering to the specific target audience. Absolute care must be given relating to
• Appropriate usage medical terminologies and abbreviations
• Style of writing and presentation
• Consistent usage of technical terms
• Proper usage of punctuation marks, hyphens, and word divisions
• Consistent spelling either in American English or British English
• Appropriate usage of tables and statistical data presentation
Thus, medical writing requires specialized training and experience to gain comprehensive subject knowledge and language usage skills to develop complex scientific and medical contents suitable for well-learned medical researchers and healthcare professionals.