Medical Writing

Medical Writing

ICBio Medical Writing team provides ICH GCP compliant Clinical Trial documents, accurately written documents as per standard formats, medical writing services ranging from entire drug development life cycle, and to the post-marketing reporting and commercialization writing. Our team of medical writers delivers accurate, timely, and cost-effective clinical and regulatory documents to the highest quality and scientific standards. Our medical writers are very flexible to meet your needs, using our expertise to transform your complex and diverse data into an accurate and evidence-based clinical profile of the drug concerning treatment/patient safety.
medical writing

Our offering includes:​

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  • Preparation of ICH GCP compliant Clinical Trial documents (Protocol
    development, Informed Consent Forms, Investigator Brochures, Patient
    Narratives, and Clinical Study Reports).
  • Labeling Documents (Patient Information Leaflets, Labelling Updates, Core
    Data Sheet (CDS) and Package Inserts).
  • Publications (Copywriting, Copyediting, Proofreading, Journal Articles,
    Manuscripts, Abstracts, Posters, and Presentations).
  • Disclosure documents (Protocol Registration, Results Disclosure, and Plain
    Language Summaries).
  • Common Technical Document (CTD) for EU and US Regulatory Authorities
  • Pharmacovigilance; Periodic Safety Update Reports (PSUR), Preparation and
    Review of Annual Safety Reports (ASRs), Development Safety Update
    Reports (DSUR), Periodic Adverse Drug Experience Reports (PADER).

Scientific Communications

  • Medical marketing reviews and reports
  • Literature reviews
  • Publication planning
  • Scientific manuscripts
  • Safety Narratives
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