There are two main areas in medical writing, medical communications and regulatory writing; this blog focuses on the latter area of specialisation, which involves the preparation of clinical study and regulatory submission documentation.
Generally, regulatory writers have a PhD in a life science, science related or medical subject and may be freelance, or employed by sponsors (e.g., pharmaceutical/biotech companies) or clinical research organisations (CROs).
Regulatory writers produce a wide variety of clinical documents throughout the life‑cycle of a (potential) treatment, starting with describing and reporting data from clinical trials, through preparing regulatory submission documents, and, if the treatment is approved by a regulatory authority, producing post-approval reports on the use of the treatment in patients. Examples of clinical documents include Investigator Brochures (IBs), Clinical Study Protocols, Clinical Study Reports (CSRs), and the Common Technical Document (CTD), but there are many, many more. The audience for these documents are usually regularity authorities and ethics committees.
The importance of preparing high quality regulatory documents is often under estimated; a CSR is the final result of many months and sometimes years of hard work by study teams, and has to summarise the conduct and results of a clinical study in a clear and unbiased manner. A well written CSR will aid the subsequent production of high quality submission documents, and conversely, poorly written or presented regulatory documents may lead to delays in regulatory approval, costing time and money for the sponsor.
In the ever changing regulatory environment, experienced regulatory writers can add a lot of value in the production of clinical study documentation. As an integral part of the clinical research process, regulatory writers can act as a pool of knowledge at every step, from protocol development to the drug submission process. Regulatory writers are skilled at meeting global regulatory requirements and adhering to guidance’s such as International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, while still fulfilling the needs, preferences and styles of sponsors/study teams. They understand, interpret, and summarise often complex scientific and statistical data whilst providing effective guidance to clinical study teams, which usually include experts from other fields such as clinical/medical, statistics, regulatory affairs, pharmacovigilance and pharmacology. Some regulatory writers can become experts in a particular therapeutic area or disease and can provide invaluable insights to the sponsors/study teams. Regulatory writers can also proof read and provide editorial support on documents produced by sponsors/study teams, if requested.
Authors note: This blog was originally published on 18/03/2011 and has since been updated.
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