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Services

Translational Research & Clinical Compliance 

  • Project management for multi-site translational and clinical studies

  • Grant, contract, and FDA/510(k) submission planning and preparation

  • Clinical validation study design and execution

  • Technical reporting for research projects, grants, and regulatory filings

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Quality Systems & Risk Management

  • Quality-management system design aligned with CAP, CLIA, FDA, and ISO standards

  • SOP and policy development, review, and implementation

  • Root-cause analysis and CAPA programs to prevent recurrence and drive improvement

  • Risk assessments and audit preparation for regulated laboratories

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Process Design & Optimization 

  • End-to-end laboratory workflow design and optimization

  • Development of reproducible testing and reporting processes

  • Process-improvement projects informed by data and stakeholder input

  • Team-centered implementation strategies to ensure adoption and sustainability

  • Defining and tracking key-performance-indicators for data driven process refinement

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Technology & Workflow Implementation 

  • Planning and oversight of new equipment acquisition, installation, and validation

  • Integration of LIMS, EDRMS, test-reporting systems, and bioinformatics pipelines

  • Implementation of IT platforms and digital reporting tools for seamless data flow

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