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Expert medical writing

Medical writing

Clinical documentation is highly regulated and the content must be clear, succinct and scientifically sound. Our professional medical writers have research backgrounds and a passion for scientific communication, as well as a thorough understanding of regulatory guidelines and expertise in clinical and regulatory writing.


Do you need support writing a clinical study protocol or report, Investigator’s brochure, clinical evaluation report, literature summary, scientific article, or even web or training content? Expert medical writing brings structured efficiency and regulatory knowledge to the process of producing these types of specialized content, which improves speed and cost-effectiveness. We also offer quality control of clinical documents which increases accuracy and ensures compliance.

Medical writing

Regulatory and clinical writing

We offer a range of medical writing services, including:

  • Clinical summaries and clinical overviews of the Common technical document (CTD), as well as non-clinical sections.

  • Clinical evaluation reports (CER) and literature reviews

  • Investigator’s brochure (IB)

  • Clinical study protocols (CSP) and clinical study reports (CSR) for drugs and biologics (ICH-E3 and E6)

  • Clinical investigation plans (CIP) and clinical investigation reports (CIR) for medical devices (ISO 14155)

  • Clinical performance study protocols (CPSP) and clinical performance study reports (CPSR) for IVDs (ISO 20916)

  • Other clinical study documentation such as patient information, informed consent, patient safety narratives, etc.

  • Medical communications and safety reports (DSURs/PSURs)

  • Posters, abstracts, manuscripts and other scientific publications.

  • Educational and training material, including web and digital content.

  • Quality control of clinical study documentation

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