June 9, 2021
Today is MedComms Day! We would like to take this opportunity to tell you about our core business activity: medical and scientific writing.
Our medical communication agency has been serving the pharmaceutical and cosmetics industries, biotech companies, manufacturers of medical devices, healthcare professionals, and the wider scientific research community for more than 30 years. How? Medical communication, and particularly the writing of regulatory and clinical documentation related to the development of drugs and other healthcare products, is an integral part of these sectors.
Many documents are needed during the development and “lifespan” of a drug, from the pre-clinical research phase to marketing and beyond. Regulatory medical writing helps industry meet this demand.
- Setting up a clinical study requires the submission of a Clinical Trial Authorization (CTA) application to the health regulatory authorities. Many documents need to be written for this application: an Investigational Medicine Product Dossier (IMPD), an investigator’s brochure, a synopsis and a clinical trial protocol, an informed consent form (ICF), etc. In addition, a Clinical Study Report (CSR) needs to be written after each trial phase to communicate the results to the regulatory authorities, and a lay summary must also be published in the European database of clinical studies.
- Preparing a drug Marketing Authorization Application (MAA) also requires specific skills, involving the writing of a Common Technical Document (CTD, clinical and nonclinical), and a Pediatric Investigation Plan (PIP), if applicable. After submitting the MAA dossier, national (e.g., the French Agency for the Safety of Medicines and Health Products, ANSM) or international (European Medicines Agency [EMA], Food Drug Administration [FDA]) health agencies usually require detailed responses to answer specific questions about the drug being assessed.
- Pharmacovigilance documents (e.g., Periodic Safety Update Reports [PSURs], Development Safety Update Reports [DSURs] are also essential documents that need to be written at various points during the “lifespan” of a drug.
Publishing the results of experimental, nonclinical, and clinical studies in peer-reviewed journals is essential for enabling researchers to share their findings with the scientific community, and thus move science forward. Scientific article writing is the first step in this process. The scientific paper is then submitted for peer review. As scientific writing is subject to specific rules and the selection criteria of peer-reviewed journals are very strict, many authors also hire a medical writer to proofread or rewrite their scientific paper before submission to increase the chance of their article being accepted for publication in their target journal. In some cases, authors feel uncomfortable writing in English and use our medical article translation or language editing services before submission of their article to an international journal.
Medical communication is also required for conferences and meetings: an abstract of the study must be submitted, and then a poster or a slide show have to be created to present the results. For after the event, some companies or associations ask us to produce a conference report intended for participants who were unable to attend. Conference reports can be produced in several formats, e.g., as conference proceedings, scientific articles, or summary slideshows. Medical writers can also write, create, and produce all these documents!
The general public also have a need for a range of documents intended for them, such as the lay summaries of clinical trials mentioned above, website content dedicated to patients, medical brochures, leaflets, scientific sketchnotes (a of mix short texts and drawings), etc.
Our team is passionate about scientific and medical writing: our profession is diverse and enriching with many various missions on many various themes!