
Non-Clinical Medical Writing

Project Management
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Create, optimize, and maintain schedules for deliverables
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Build and implement standard project timelines, establish processes, and map dependencies among workstreams
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Implement tracking and projection tools to increase team efficiency
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Determine resource projections for short, medium, and long-term schedules
Capabilities:
CTD Module 4
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Technical editing support for nonclinical study reports
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Quality review for nonclinical study reports
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Collaborative authoring services
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Template development for programs or individual reports
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Publishing and submission capabilities
CTD Module 2
Review and synthesis of data for summary reporting including:
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Nonclinical overview (Module 2.4)
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Nonclinical written summaries (Modules 2.6.1, 2.6.2, 2.6.4, & 2.6.6)
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Nonclinical tabulated summaries (Modules 2.6.3, 2.6.5, & 2.6.7)
Determine applicable regulations and their implication in summary reporting
Regulatory Interactions
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Develop briefing documents including summarizing nonclinical packages and rationale for clinical program design
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Writing team expertise across meeting types (Type A, B, C, and D)
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Serve as a primary author or support Sponsor’s team
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Conduct comprehensive quality review
The GLOBAL Team
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Expertise in development of IND-required nonclinical reporting
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Writers with unique skills sets offering full circle knowledge of nonclinical requirements and their impact to clinical development programs
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Single-team approach offering continuity and consistency to our Sponsors across programs
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High rate of repeat business due to excellence in performance
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Ability to contract on a per-project basis or as FTE with built-in back-up resourcing
Other Document Experience and Service Offerings
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Development of full protocols
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Investigator’s Brochure initial versions and updates
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Aggregate safety reporting including clinical and nonclinical sections
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Poster presentations and abstracts for industry and scientific meetings/conferences
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Style guide development to support writing consistency across programs
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Publishing and submission capabilities
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Training on templates, style guides, and best practices for document development