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  • Services
    • Regulatory
      • Clinical Documentation
      • Briefing Book
      • Clinical Development Plan
      • Clinical Study Protocol (CSP)
      • Clinical Study Report (CSR)
      • Lay Summaries
      • Common Technical Document (CTD)
      • Informed Consent Form (ICF)
      • Investigator’s Brochure (IB)
      • Investigational Medicinal Product Dossier (IMPD)
      • Investigational New Drug (IND)
      • Paediatric Investigation Plan (PIP)
      • Pediatric Study Plan (PSP)
      • Responses to Authority Questions
      • Clinical Evaluation Report (CER)
      • Other Documents
    • Postmarketing
      • Postmarketing Studies
    • Pharmacovigilance
      • PV & Product Safety
      • 120 Day Safety Update (4 Month Safety Update)
      • Development Safety Update Report (DSUR)
      • Periodic Adverse Drug Experience Report (PADER)
      • Periodic Safety Update Report (PSUR)
      • Periodic Benefit Risk Evaluation Report (PBRER)
      • Risk Evaluation and Mitigation Strategies (REMS)
      • Risk Management Plan (RMP)
    • Communications
      • Scientific Communications
      • Abstracts and Manuscripts
      • Posters and Slide Sets
    • Training
      • Training Overview
      • Training Portfolio
      • Foundation Skills Training Programme
      • Preparing Specific Clinical Documents
      • Strategic Communication Skills
  • Why Trilogy?
    • What is Medical Writing?
    • Why use Trilogy?
    • Outsourcing
    • Expertise
    • Therapeutic Areas
    • Development Areas
    • Trilogy Benefits
    • How We Work
    • Trilogy Style Guide & Tools
    • Document Review Process
    • Customer References
    • Trilogy Brand Brochure
  • AI
    • NEXT Medical Writing Automation
  • About Us
    • Our Story
    • Trilogy Management Board
    • FAQ
  • Resources
    • TriloTalk | Podcast
    • Publications
    • Medical Writing Special Editions
      • Special Edition: Medical Writing: The Backbone of Clinical Development
      • Special Edition: Medical Writing – A Bold New Path: The Future Awaits Us
      • Clinical Study Protocols: The Pillars of Clinical Development
    • Think Tanks
    • Glossary of Clinical Research Terms
    • News: Regulations & Standards
  • Careers
    • Come join us
    • Life at Trilogy
  • Contact

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