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Medical Writing

Medical Writers

Our Medical Writers have a broad range of expertise in:

  • Technical Writing
  • Submission Authoring
  • Clinical Documents Creation
  • Product Surveillance Documentation
  • Clinical Analysis and Reporting
  • Clinical Abstracts
  • Manuscripts Support
  • Study Brochures
  • Marketing Documentation and Review

Specialized Medical Writing Services

Whether you are looking for support with clinical study documentation or planning on submitting a new product we have the expertise to support you. 

  • Clinical Documentation Templates
  • Support with Submissions
  • Briefing Books
  • Clinical Development Plan (CDP)
  • Clinical Study Protocol (CSP)
  • Clinical Study Report (CSR)
  • Common Technical Document (CTD)
  • Informed Consent Form (ICF)
  • Investigator’s Brochure (IB)
  • Investigational Medicinal Product Dossier (IMPD)
  • Investigational New Drug (IND)
  • Pediatric Investigation Plan (PIP)
  • Responses to Authority Clinical Questions
  • Clinical Evaluation Reports (CER)
  • Post-Market Surveillance Report
  • Clinical Analysis
  • Summary of Safety and Clinical Performance (SSCP)

Clinical And Regulatory Solutions

Our Medical Writers bring a broad range of expertise within Clinical and Regulatory compliance. We focus in a solutions based approach for the entire lifecycle of the device or drug.

Interested In Our Services? We're here to help!

Trinity M Consulting