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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 Citrine Healthcare undergo thorough scientific, statistical, editorial and quality control review.

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

Regulatory and Clinical Writing
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ICH GCP compliant Clinical Study Reports (CSRs); Phases I to IV, including CSR Synopses for public disclosure
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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
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Clinical and non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU and US Regulatory Authorities
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Investigator Brochures
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Study Protocols
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Patient Safety Narratives
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Pharmacovigilance documents such as Periodic Safety Update Reports
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Patient information including Informed Consent, Lay Person Summaries and Patient Brochures
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Standalone Quality Checks
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