RLS Protect Docs (Redaction)
AI-powered classification and redaction of personal data and confidential information in clinical trial documents for regulatory transparency.
Overview
RLS Protect Docs (Redaction) is a SaaS platform from Real Life Sciences designed for pharmaceutical sponsors and CROs that need to redact personal data and commercially confidential information (CCI) from clinical trial documents. The platform uses AI to accelerate classification and redaction workflows, and has been applied to thousands of documents totalling over 1,000,000 pages. According to Real Life Sciences, RLS Protect operates 25–50% faster than standard redaction tools such as Adobe.
The platform addresses regulatory transparency obligations including Health Canada PRCI, EMA Policy 0070, and EMA CTR/CTIS, supporting both internal and external data sharing requirements. It is built to serve both sponsor teams and CRO teams working on clinical transparency projects.
Personal Data Search and Classification
- Systematic classification of personal data variables including patient IDs, age, gender, and race.
- Hundreds of predefined searches for automatic classification of names, dates, email addresses, phone numbers, and additional data types.
Commercially Confidential Information (CCI) Management
- Save, search, and classify CCI within clinical documents.
- CCI justification notes captured by the user and exported to reports for use in a Justification Table.
Reporting and Audit Capabilities
- Multiple reports available for quality control review of document marks and annotations.
- Audit reporting captures original syntax, revised syntax, category, user, and notes.
- Automated Marks Report can be generated for one or multiple documents simultaneously.
- Marks Report provides a view of CCI redaction justifications and serves as a complete audit history of document markings and changes, including filename, identifier type, page number, and mark sequence for each redaction.
- Used to QC document redactions across projects.
Regulatory Compliance Support
- Supports compliance with HC PRCI, EMA Policy 0070, and EMA CTR/CTIS disclosure regulations.
- Supports both internal and external sharing requirements.
- Allows systematic switching of mark style requirements between Health Canada and EMA formats.
Clinical Transparency Project Management
- Project templates to accelerate setup of specific project plans.
- Assignment of resources to tasks.
- In-app collaboration and messaging.
- Custom fields for tracking project work.
- Alerts and notifications.
- Project reporting.
- Integrated file management and storage.
RLS Protect is designed for use by both pharmaceutical sponsors and CROs, enabling teams to share projects internally and externally to support expedited completion of transparency obligations. The platform is developed by a team with backgrounds in machine learning, natural language processing, clinical trials, data analysis, and regulatory submissions.
