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    Medical Writing Services

    Give your regulatory submission the best chance for approval with well written regulatory documents throughout all stages of the drug development process.

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    Medical Writing CRO

    Medical Writing is an integral part of clinical research and our team of specialist medical writers deliver accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards.

    Our medical writers become an extension of your team by being responsive and flexible to your needs, using our expertise to transform your complex and diverse data into an accurate and evidence-based account of the clinical profile of your drug in relation to treatment and patient safety.

    We have a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. All documents produced by Quanticate undergo thorough scientific, statistical, editorial and quality control review.

    Quanticate’s medical writing services include clinical and regulatory writing, as well as scientific communications, education material and medical writing consultancy.

    Regulatory and Clinical Writing

    ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
    Standard Operating Procedures (SOPs) covering all aspects of drug development including the design, conduct and reporting of clinical trials and the outsourcing of Sponsor responsibilities to a CRO
    Clinical and non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
    Investigator Brochures
    Study Protocols
    Pharmacovigilance documents such as Periodic Safety Update Reports
    Patient information including Informed Consent, Lay Person Summaries and Patient Brochures
    Standalone Quality Checks

    Scientific Communications

    Conference materials (abstracts, poster presentations and slide sets)
    Manuscripts
    Editorial support
    Journal/conference submission
    Product website content (for both scientific and patient audiences)
    Educational material for patients, healthcare professionals and pharmaceutical industry personnel
    Medical marketing reviews and reports
    Literature reviews
    Publication planning

    Ensure your regulatory submission is approved with well written documents throughout all stages of the drug development process

    Submit an RFI

    Resources to help you with well written regulatory documents

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    Learn how to reduce your Medical Writing narrative production timelines

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    Understand the current regulatory requirements for patient safety narratives

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    Explore the role of a medical writer in the design of Phase I studies

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    Discover how Medical Writers should contribute towards a quality ISS/ISE

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