Clinical Transparency

Clinical Transparency by Medispend is the industry-leading solution designed to scale internal transparency processes for pharmaceutical Sponsors and CROs through risk-based quantitative anonymization and document redaction. Purpose-built to meet the growing demands of regulatory bodies, the platform has successfully anonymized over 1.75 million pages and thousands of datasets, helping life sciences organizations protect patient identity, maximize data utility, and comply with all applicable transparency regulatory requirements.

The solution supports adherence to Health Canada and EMA regulations including PRCI, Policy 0070, and CTR, while also enabling voluntary data sharing initiatives through RLS Protect and RLS service delivery experts. With 65+ PRCI and CDP/Policy 0070 projects completed, Medispend brings deep domain expertise and advisory services to every engagement.

Quantitative Risk-Based Anonymization

• Moves beyond traditional rules-based approaches that fail to measure re-identification risk or data utility
• Fulfills all Anonymization Report (AnR) requirements as defined by the Health Canada and EMA shared template
• Captures key anonymized variables, risk thresholds, risk of re-identification before and after anonymization, and reference population methodology
• Ensures submissions meet and exceed regulator expectations through a rigorous quantitative data analysis approach

Document Redaction and Automated Workflows

• Delivers repeatable, automated workflows to batch process, model, and anonymize datasets and documents
• Saves significant time by replacing highly manual, difficult-to-quality-control processes
• Allows users to save project-specific searches and identify personal data variables and confidential information across multiple documents simultaneously
• Systematically reports on all confidential information justifications for audit purposes and internal awareness

Promoting Data Sharing and Secondary Research

• Balances patient privacy protection with the need to maintain clinical data utility
• Supports transparency and voluntary data sharing initiatives with confidence that patient data is protected
• Enables secondary research bodies to benefit from shared clinical data while preserving patient privacy
• Encourages innovation and secondary research through responsible data sharing practices

Training, Advisory, and Support Services

• Extensive documentation and training modules to help organizations transition from qualitative and manual redaction to advanced quantitative and automated anonymization processes
• Expert advisory services including webinars and trainer-led tutorials covering the latest de-identification techniques and regulatory changes
• Technical support services providing end-to-end production implementation support
• On-demand anonymization business process outsourcing to handle volume spikes in submission activity

Medispend's Clinical Transparency solution is part of a comprehensive suite of enterprise software and services for global regulatory and commercial compliance, medical affairs, field enablement, and revenue management — designed to empower life sciences companies to grow their business compliantly. The platform supports seamless submission processes to regulators and is backed by Medispend's service delivery experts throughout the project lifecycle.