Shadow

Shadow™ is a data anonymization and de-identification tool developed by GENINVO, designed specifically for Life Sciences companies navigating complex and evolving global data transparency requirements. The platform automates the de-identification of data, documents, and DICOM images, replacing inefficient homegrown utilities with a robust, maintainable, and future-ready solution that allows teams to focus on science and results.

Shadow™ is fully compliant with Health Canada, France's MR001-MR004, EMA Policy 0070 (Initial and Revised phases), 21 CFR Part 11, and GDPR, making it a comprehensive solution for organizations with global data sharing and de-identification obligations. It is part of GENINVO's broader suite of tools, which also includes the Data Collaboration Platform and the CCI Tool for safeguarding sensitive information.

Key Features

• De-identification and anonymization of data, documents, and DICOM images
• Ability to store and apply de-identification strategies in a metadata repository at Global, Therapeutic Area, Compound, Study, and Project levels
• Interactive application and testing of data and document rules
• Dual-frame before-and-after views of data and documents during the de-identification process
• Template-driven anonymization using predefined or custom templates to automate large volumes of strategies in a single operation
• Multi-language strategy import support, allowing strategies applied to an English document to be imported directly to other language versions of the same document
• CCI Open Search to identify already-published commercially confidential information from open web sources, helping teams know in advance what to exclude during anonymization
• Risk analysis tools to determine the risk of re-identification before and after de-identification, ensuring required thresholds are met
• Data utility evaluation to assess the impact of de-identification strategies and ensure consumers can reproduce analyses
• Ability to generate Redaction Proposals and Reports
• Performance metrics to evaluate the precision, efficiency, and effectiveness of strategy application and de-identification team personnel

Core Capabilities

• Real-time Results: Immediate visibility into the effects of de-identification strategies as they are applied, enabling teams to tailor and refine their approach on the fly
• Dynamic Strategy Repository: Access to predefined "canned" de-identification strategies for CDISC SDTM and ADaM standards, as well as the ability to develop and store custom strategies for proprietary data and document standards
• Anonymization Reports: Comprehensive reporting to drive, describe, and monitor anonymization projects throughout their lifecycle
• Process Workflows: Structured guidance for project teams through de-identification, review and approval, and final anonymization stages

Compliance and Integration

• Compliant with Health Canada, France's MR001-MR004, EMA Policy 0070 (Phase 1 and 2), 21 CFR Part 11, and GDPR
• Supports global data sharing requirements across multiple regulatory jurisdictions
• Integrates within GENINVO's broader product ecosystem, including the Data Collaboration Platform for seamless teamwork and the CCI Tool for protecting sensitive information, enabling a smooth end-to-end workflow for secure and collaborative data management