Medical Writing and Publishing

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Manage constantly evolving regulatory protocols and submission guidelines with our experts. Get collaborative, affordable support for clinical, data management, and biostatistics groups — whether you need minimal support or a whole team. From protocol development to regulatory support to publishing, our expertly prepared reports comply with local and ICH guidelines.

Our experts support writing and regulatory services to ensure complete, compliant, and high-quality deliverables. Receive documents that have undergone rigorous scientific, statistical, editorial, and quality control review,  compliant with FDA, EMA, and other regulatory requirements.

Quartesian’s services cover medical and regulatory writing, scientific communications, and publishing. These services include:

Medical Writing and Regulations

  • ICH and GCP compliant clinical study reports (CSRs)
    • Phases I to IV
    • Including CSR synopses for public disclosure
  • Study protocols and design
  • Clinical and non-clinical sections of the Common Technical Document (CTD)
    • Summaries and overviews for EU and US Regulatory Authorities
  • Investigator brochures
  • Patient safety narratives
  • Patient information
    • Informed consent brochures
    • Patient brochures
  • Pharmacovigilance documents
    • Periodic safety update reports
  • Clinical trial registration and results postings on clinicaltrials.gov.
  • Data Safety Monitoring Board (DSMB) Charter writing
  • Standard operating procedures (SOPs)
    • Covering all aspects of drug development including clinical trial design, conduct, and reporting, and the outsourcing of sponsor responsibilities to a clinical research organization (CRO)

Scientific Communications

  • Conference materials
    • Abstracts
    • Poster presentations
    • Slide decks
  • Manuscripts
  • Editorial support
  • Journal/conference submission
  • Website content
    • Both scientific and patient audiences
  • Educational material for patients, healthcare professionals, and pharmaceutical industry personnel

Publishing

  • Publishing Overview
    • Clinical study report publishing, protocol publishing, SAP, RMP, PSUR, PSMF, IMPD, DSUR or other report level publishing as per client style guide and ICH requirements
    • Case report form (CRF) publishing
    • Bulk publishing of literature references, investigator documents, or any standalone documents
    • Redaction services for removing patient identifiers
    • Word compliance checking for formatting as per client style guide
    • eCTD submission readiness of legacy files
    • Creating published outputs of CSRs using Client dossier-publishing tools and document management system
  • Report-level/Document/Pre-Publishing
    • CSRs
    • CRFs
    • Investigator brochures
    • Protocols
    • Narratives
    • Safety reports
    • PSMF (PV report)
    • Nonclinical Reports
    • Others
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  • Submission Publishing
    • Format documents for e-submission
    • Create a dossier by compiling all required documents with application
    • Post publishing, run final output through validators to ensure compliance
    • Provide the output or dispatch through gateways to health agencies on your behalf
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