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Global Regulatory Medical Writing Services

Our medical writing experts ensure that your scientific and medical communication materials are clear, concise, scientifically accurate and fully compliant with regulations, industry best practices and your corporate guidance.

Comprehensive Medical Writing Services

PPD offers a comprehensive suite of medical writing services to support your clinical trial documentation needs from the early phases of development through post-approval. These services can be offered on a stand-alone basis or as an integrated part of a clinical trial, drug development program or medical information service.

Our medical writing team consists of Pharm.D., M.D., Ph.D. and master’s level writers with diverse therapeutic backgrounds who can support preparation of a wide range of medical communication materials, including:

  • Phase I-IV protocols
  • Phase I-IV integrated clinical statistical reports (ICSR)
  • Global clinical trial applications
  • Drug, device and biologic marketing applications
  • Formulary dossiers
  • Standard responses
  • Investigator brochures
  • Scientific slide sets
  • Manuscripts and posters
  • Risk evaluation and mitigation strategy (REMS)
  • Medication guides and patient information leaflets (PILs)
  • Contact center materials
  • Premarketing and post-approval annual reports
  • Periodic safety reporting
  • Patient safety narratives
  • U.S. Food and Drug Administration (FDA) briefing documents
  • Risk management plans
  • Pediatric investigational plans
  • Medical editing

Focus on Quality and Efficiency

Our medical writers prepare clear, well-written documents designed to exceed expectations in terms of both content and formatting. Document development occurs with regular consultation to ensure that project needs are incorporated and client preferences for presentation are followed. All documents are prepared on time and are scientifically sound and fully compliant with any applicable regulatory guidelines.

Review Models to Ensure Quality

All PPD documents undergo a rigorous review process to ensure that documents produced are of the highest quality. A team of project-specific reviewers is selected to ensure the materials are grammatically correct, scientifically logical and completely accurate. Quality reviewers also ensure compliance with audience-appropriate style as reflected in standard sources such as the AMA Manual of Style and the Oxford Style Manual as well as client-preferred style guidance. Editorial reviewers have certification from the Board of Editors in the Life Sciences.

Comprehensive Product Lifecycle Support

With strong scientific expertise, technology-driven solutions, global infrastructure and an unrelenting standard of quality, PPD’s global medical writing group provides comprehensive medical writing services that span the entire product life cycle.

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