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Supporting 21 CFR Part 11 compliant data management

Flywheel Trial Flow is a scalable data management and workflow solution to efficiently and securely access, process, analyze and share imaging and associated data for clinical trials and other research requiring 21 CFR Part 11 compliance.

An infrastructure supporting clinical and research data management workflows

Flywheel Trial Flow provides clinical workflow data management, including file capture and verification, integration with clinical data, automation of image processing routines, and comprehensive audit trails across all data elements and user actions. Data from Trial Flow can move into Flywheel Enterprise, a platform for optimized research workflows, machine learning and exploratory analysis.

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A data management tool to enable imaging data in clinical trials

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Capture

  • Secure web-based uploads
  • Client-side de-identification
  • PHI review and verification
  • Connectivity with your preferred imaging workstations.
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Curate

  • Automated metadata validation and QC
  • Container-based image processing and analysis
  • Query support
  • Patient, site, and study-level data locking

 

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Quantify

  • Generate quantitative insights from images
  • Container-based image processing and analysis
  • Reader studies
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21 CFR Part 11 Compliance

  • Electronic signatures, role-based access controls and data locking capabilities
  • Detailed logging of data access.
  • Study site monitoring and site query interface.
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Flywheel Trial Flow

Flywheel Trial Flow, a clinical trial data management system, can optimize data management for clinical workflows requiring 21 CFR Part 11 compliance while integrating with Flywheel Enterprise to manage research projects needing iterative development, machine learning workflows and collaboration.