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Non-Clinical Medical Writing

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Project Management

  • Create, optimize, and maintain schedules for deliverables

  • Build and implement standard project timelines, establish processes, and map dependencies among workstreams

  • Implement tracking and projection tools to increase team efficiency 

  • Determine resource projections for short, medium, and long-term schedules


CTD Module 4

  • Technical editing support for nonclinical study reports

  • Quality review for nonclinical study reports

  • Collaborative authoring services

  • Template development for programs or individual reports

  • Publishing and submission capabilities


CTD Module 2

Review and synthesis of data for summary reporting including:

  • Nonclinical overview (Module 2.4) 

  • Nonclinical written summaries (Modules 2.6.1, 2.6.2, 2.6.4, & 2.6.6) 

  • Nonclinical tabulated summaries (Modules 2.6.3, 2.6.5, & 2.6.7) 

Determine applicable regulations and their implication in summary reporting

Regulatory Interactions

  • Develop briefing documents including summarizing nonclinical packages and rationale for clinical program design

  • Writing team expertise across meeting types (Type A, B, C, and D)

  • Serve as a primary author or support Sponsor’s team

  • Conduct comprehensive quality review


  • Expertise in development of IND-required nonclinical reporting 

  • Writers with unique skills sets offering full circle knowledge of nonclinical requirements and their impact to clinical development programs

  • Single-team approach offering continuity and consistency to our Sponsors across programs

  • High rate of repeat business due to excellence in performance

  • Ability to contract on a per-project basis or as FTE with built-in back-up resourcing

Other Document Experience and Service Offerings

  • Development of full protocols 

  • Investigator’s Brochure initial versions and updates 

  • Aggregate safety reporting including clinical and nonclinical sections 

  • Poster presentations and abstracts for industry and scientific meetings/conferences

  • Style guide development to support writing consistency across programs

  • Publishing and submission capabilities

  • Training  on templates, style guides, and best practices for document development

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