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Elevation Strategic Development, LLC

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Morrison, Colorado, US

About Elevation Strategic Development, LLC

Providing clinical, regulatory, and scientific consulting and services in pharmaceutical, diagnostic, and medical device product development

Expertise in:

• Design and timing of companion/complementary diagnostic development, such as:

  • Patient selection for early and late phase clinical trials,... Show more »

Providing clinical, regulatory, and scientific consulting and services in pharmaceutical, diagnostic, and medical device product development

Expertise in:

• Design and timing of companion/complementary diagnostic development, such as:

  • Patient selection for early and late phase clinical trials, including risk determination
  • IDE and/or CLIA requirements and compliance
  • Assay endpoint selection and validation design
    • Biomarker hypothesis development
    • Oncology, rare disease, inflammation, and infectious disease therapeutic areas
    • IVD design and validation for codevelopment and stand-alone applications
    • Use of clinical trial assays to support pharmacodynamic endpoints
    • Vendor and clinical trial site selection for RUO/IUO IVD development and testing
    • Global development standards, guidelines, and regulations (eg, GCP, QSR, IVDR, ISO, ICH, CAP/CLIA)
    Services include:
    • Comprehensive and/or focused pharmaceutical and medical device pre- and postmarket development consulting
    • Medical writing and editing: study protocols, clinical reports, regulatory submissions/filings (510k, IDE, etc)
    • Regulatory communication support, including briefing package generation and responses to feedback
  • Examples: Pre-Submission meetings, Risk Determination, Informational meetings, Type C meetings, Protocol Advice/Scientific Advice Requests
    • Review of validation plans, study protocols and reports, regulatory submissions, etc
    • Conduct PMCF studies, including generation of clinical investigation/study plans and reports
    • Quality Management System evaluation and building
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Our Services (7)


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Regulatory Affairs Consulting

Price on request
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Clinical Trial Site Selection

Price on request
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Product Development Consulting

Price on request
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Scientific Consulting

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Medical Writing

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Regulatory Document Preparation and Submission

Price on request
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Quality Management Systems Consulting

Price on request
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Staci Kearney

President

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