Medical writing helps communicate the goals and strategies of a clinical trial or program to patients, sites, sponsors, and regulatory agencies.
At Argos, our medical and pharmaceutical experts have diverse scientific knowledge as well as extensive pharmaceutical development experience, which allows them to produce clear and concise documents for medical and pharmaceutical companies anywhere in the world. Our industry and regulatory experience gives us expertise in a wide range of medical and pharmaceutical documentation, most of which falls into two primary categories:
Clinical and regulatory documentation
Protocol synopses, protocols, and amendments
Clinical study reports
Patient documentation (safety narratives, information leaflets, brochures, and informed consent forms
Clinical development plans
Standard operating procedures
Reporting: PSURs, DSURs, PBRERs
Summaries of product characteristics, clinical safety, and clinical efficacy
Investigational medicinal product dossiers
Regulatory briefing documents
Risk management plans
Commercial and scientific communication
Presentations and slide decks
Educational and training material
White papers, publications, and manuscripts
Product website content
Multimedia and layouts
Our on-site and remote resource pool includes medical writers, copywriters (for digital marketing content), project managers, translators, quality control resources, and layout/multimedia specialists. Every individual we collaborate with has the right educational qualifications, domain knowledge on therapeutic areas and regulatory/scientific guidelines, and the ability to write concise, error-free copy that’s perfectly suited for translation and localization.
Our standard practice is to arrange kickoff and review meetings, designate document ownership according to therapeutic areas, maintain consistent messaging and version integrity, build and utilize a style guide unique to each piece of content, and make sure that everything we produce is concise, unambiguous, and ready for localization.
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