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ClinDatrix, Inc

The Experience of Big. The Advantage of Value.

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      • Louise M. Murphy, PhD, MBA, CQA
      • Brian G. Murphy, BEng, PhD
      • Steve O. Balyakin, MD, PhD, FFPM, CMC
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    • Clinical Trial Project Management
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    • Harnessing the Power of Oracle InForm with ClinDatrix
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  • Contact Us
  • About Us
    • Leadership
      • Louise M. Murphy, PhD, MBA, CQA
      • Brian G. Murphy, BEng, PhD
      • Steve O. Balyakin, MD, PhD, FFPM, CMC
    • Quality
    • Infrastructure
    • Strengths
    • News & Events
    • Privacy Policy
  • Services
    • Clinical Trial Project Management
    • Clinical Trial Investigator Meetings & Event Planning
    • Clinical Trial Monitoring
    • Clinical Trial Medical Monitor & Medical Safety
    • Clinical Trial Data Management
    • Clinical Trial Biostatistics
    • Medical Writing Services
    • Clinical Regulatory Affairs
    • Quality Assurance for Clinical Trials
    • Clinical Trials Consultant
      • Engineering
      • Data Management
      • Biostatistics Consulting
  • Therapeutic Areas
  • Medical Devices
  • Technology
    • Harnessing the Power of Oracle InForm with ClinDatrix
    • SAS
    • NQuery
    • IRT, IWRS
  • Global Affiliates
    • Venn Life Sciences
    • DOT International
    • OnQ Research
    • Research & Development RA S.A.
    • IPSUM
    • Q-Trials
    • ClinGroup
    • Q2 Business Intelligence
    • ComboTrial
  • Contact Us

Medical Writing Services

Home » Services » Medical Writing Services
Medical writing for clinical trials.

From protocol development to clinical study reports and regulatory documents, ClinDatrix medical writers ensure clear written communications with sites, investigators and regulatory agencies throughout the product development and commercialization process.

Among the types of documents our medical writers prepare are the following:

Clinical Documents

  • Clinical protocol, protocol synopsis and protocol amendments
  • Investigator brochures
  • Interim clinical study reports (CSRs)
  • Final CSRs

Medical Monitoring and Patient Safety Documents

  • SAE reports with narratives
  • Annual safety reports

Regulatory Documents

  • INDs, NDAs
  • PMAs, IDEs, 510(k)s
  • Annual reports (IND, NDA, orphan drug, etc.)
  • Periodic safety update reports
  • Module 2 and Module 5 summaries
  • Non-clinical study reports
  • Agency cover letters and communications
  • Briefing documents
  • Agency response documents
  • Product labeling
  • Requests for meetings

Journal Articles

Technical Analyses

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ClinDatrix, Inc. * 19 Rosana Way * Coto de Caza, CA 92679 * Tel: 949.235.4045

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