Redaction and Anonymization

Protect sensitive personal and commercial information in compliance with global regulations without compromising data utility.

De-identification with fast, trusted results

Xogene provides document redaction and anonymization services, seamlessly blending advanced pattern recognition with deep regulatory expertise. Our technology-driven approach guarantees precise, cost-effective results, ensuring the highest quality for all your clinical documentation needs.

Leaders in transparency

Full service redaction and anonymization

Whether you're submitting under EMA Policy 0070 or Health Canada PRCI, responding to external information requests, or managing document uploads for registries, our specialized services cover your complete anonymization and redaction requirements.

Our technology-enhanced approach is enabled by Xogene's in-house tool, Determinator. We consistently deliver superior results for both English and translated documents, while reducing costs and accelerating timelines for your clinical transparency requirements.

Our services include:

Support for all redaction types: Third Party Researcher Requests, EU CTIS Redactions (English and 200+ other languages), Journal Publication Redactions, Redaction of Documents for Country-specific Registries
Complete EMA Policy 0070 and Health Canada PRCI Packages: Full submission support including redaction proposals, anonymization reports, justification tables, cover letters, and final anonymized documents
Regulatory Agency Support: Subject matter experts participate in pre-submission and/or project initiation meetings with regulatory agencies and help sponsors prepare in advance of that meeting
Risk Assessment: Support for submission packages with qualitative and quantitative risk methodology and full visibility into calculations.
Advanced PPI Protection: Automated redaction of Protected Personal Information using AI-powered pattern recognition
Intelligent Data Anonymization: Machine learning solutions that help with the transformation of information and maintain data integrity while ensuring compliance
Strategic CCI Management: Commercially Confidential Information redaction with review of company policies against regulatory requirements
US Final Rule Compliance: Specialized SAP and Protocol redaction services
Rapid Response Solutions: Expedited 24–48 hour redaction for time-sensitive EMA Policy 0043 requests
End-to-End Project Support: Communication planning, process oversight, dedicated project management, and stakeholder training