CIS

CIS™ (Confidential Information Scanner) is an AI-powered commercially confidential information (CCI) redaction and detection tool developed by GenInvo, purpose-built for the life sciences industry. It is designed to safeguard sensitive and confidential information within anonymized clinical documents, regulatory submissions, and research records, ensuring compliance with global data-sharing and transparency regulations. CIS™ serves pharmaceutical sponsors, clinical research organizations, and regulatory affairs teams who need a reliable, scalable alternative to slow and error-prone manual redaction processes.

By combining Artificial Intelligence and Machine Learning through sophisticated hybrid AI algorithms, CIS™ accurately detects, classifies, and protects confidential data across documents and repositories. The solution addresses key regulatory frameworks including EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (MR001–MR004), HIPAA, GDPR, and 21 CFR Part 11, enabling organizations to remain compliant while focusing on science and innovation.

Core Capabilities

• 50+ Industry-Specific Confidentiality Categories: CIS™ comes preloaded with more than 50 categories tailored for life sciences, covering every stage from drug discovery through to regulatory submission, ensuring all relevant confidential elements are captured throughout the development lifecycle.
• Customized Scanning Across Sources: The tool can be configured to scan across internal document repositories, regulatory portals, and open web sources, adapting flexibly to specific organizational workflows.
• Automated Re-Scanning: Scheduled and automated re-scanning continuously checks for updates to documents and repositories, ensuring confidential information remains protected and compliant as requirements evolve.
• Intelligent Document Scanning: CIS™ scans clinical trial reports, regulatory submissions, and internal documents with AI-powered precision, reducing manual effort and minimizing the risk of overlooking sensitive data.
• Customizable Reporting: The tool generates well-formatted, human-readable Excel reports presenting findings clearly for compliance and audit teams, designed to speed up review and decision-making.
• CCI Source Navigation: Users can instantly pinpoint confidential information by navigating directly to the exact page, section, or PDF where data was identified, streamlining the review process and building confidence in findings.
• Centralized Asset CCI Database: A centralized CCI database enables consistent redactions to be applied across all documents by storing and reusing CCI intelligence, ensuring efficiency and compliance across every project.

Confidentiality Category Coverage

• Confidentiality Obligations: Tracks and safeguards sensitive commercial information, payment agreements, and confidentiality clauses to ensure contractual obligations remain protected and compliant.
• Projected Key Dates and Development Milestones: Protects critical study timelines, trial milestones, and projected development dates from unintended disclosure while maintaining required transparency.
• Facilities and Third-Party Involvement: Securely scans and monitors confidential details about research facilities, laboratories, and third-party vendors without impeding collaboration.
• Asset and Study Information: Safeguards asset pipelines and study-related details throughout the drug development lifecycle across internal and external exchanges.
• Other Sponsor Medicines or Vaccines: Protects sensitive information relating to sponsor medicines or vaccines used in combination or as comparators, reducing the risk of competitive intelligence leaks.
• Other Non-Sponsor Medicines or Vaccines: Scans and secures confidential references to non-sponsor drugs or vaccines in trials or comparative studies while preserving regulatory clarity in submissions.
• Sponsor-Supported Studies: Identifies and protects confidential information in sponsor-backed studies, from protocols to trial results, safeguarding sponsor interests across submissions.
• Supported Collaborative Studies: Protects sensitive details in multi-sponsor or collaborative research projects, ensuring confidentiality obligations are honoured without slowing innovation.

Workflow and Integration

• CIS™ integrates seamlessly with existing document repositories and custom regulatory portals, providing a centralized and secure way to manage sensitive information throughout its lifecycle.
• The tool supports secure data collaboration when paired with GenInvo's Shadow de-identification solution, allowing organizations to share information without compromising confidentiality.
• Automated and scheduled re-scanning workflows ensure ongoing protection without requiring manual intervention as documents are updated or new submissions are prepared.
• Source navigation links findings directly to specific pages, sections, or PDFs, enabling compliance and regulatory teams to efficiently verify and act on identified confidential information.

CIS™ is deployed as part of GenInvo's broader life sciences technology platform and is designed to meet the compliance demands of organizations operating under multiple international regulatory frameworks. It is suitable for pharmaceutical sponsors, CROs, and regulatory affairs professionals seeking to reduce compliance risk, strengthen data security, and preserve organizational trust in an increasingly complex data transparency landscape.