Shadow

Shadow is a comprehensive solution designed to automate the de-identification and anonymization of data and documents, addressing the needs of the life sciences industry. It is particularly useful for companies needing to comply with regulations such as Health Canada, France’s MR001-MR004, and EMA Policy 0070 (Phase 1 and 2). Shadow is compliant with 21 CFR 11 and GDPR, supporting global data sharing and de-identification requirements.

Key features of Shadow include the ability to store and apply de-identification strategies at various levels, such as global, therapeutic area, compound, study, and project levels. Users can interactively apply and test data and document rules, with dual-frame views showing before-and-after states during the de-identification process. Performance metrics are available to evaluate the precision and efficiency of strategy applications and the effectiveness of de-identification teams.

• Compliance with Health Canada, France’s MR001-MR004, and EMA Policy 0070 for data, document, and DICOM image de-identification.
• CCI Open Search for existing CCI information to be excluded during anonymization.
• Template-driven anonymization for automating recurring strategies.
• Multi-language strategy support for applying strategies across different language versions of documents.
• Risk analysis tools to assess re-identification risks before and after de-identification.
• Real-time results to tailor the effectiveness of de-identification strategies.
• Data utility evaluation to ensure the ability to reproduce analyses post-de-identification.

Shadow also offers a dynamic strategy repository, allowing users to utilize predefined de-identification strategies or develop their own to meet specific data and document standards. Process workflows guide users through de-identification, review, approval, and anonymization stages, ensuring a streamlined approach to managing sensitive information.