In the life sciences industry, protecting Confidential Company Information (CCI) is paramount. As regulatory agencies such as the FDA (Food and Drug Administration), EMA (European Medicines Agency), PMDA (Pharmaceuticals and Medical Devices Agency), Health Canada, etc. emphasize transparency, organizations must ensure that proprietary information remains secure. GenInvo’s Confidential Information Scanner (CIS) Tool offers an AI-driven solution to identify and manage CCI effectively.
Defining Confidential Company Information (CCI)
Different regulatory bodies provide specific definitions for CCI:
- European Medicines Agency (EMA): Under EMA Policy 0070, CCI is defined as: “Any information contained in the clinical reports submitted to the Agency by the applicant/MAH that is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.”
- Health Canada: According to the Food and Drugs Act, Confidential Business Information (CBI) is: “Information that is not publicly available, where its disclosure could result in material financial loss or gain to a person, or could prejudice the competitive position of a person.”
- U.S. Food and Drug Administration (FDA): The FDA defines Confidential Commercial Information as: “Valuable data or information which is used in a business and is of such type that it is customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the entity to whom it belongs.”
Regulatory Guidelines on CCI
Regulatory agencies have established guidelines to protect CCI:
- EMA Policy 0070: Mandates the publication of clinical data while allowing redaction of CCI to protect economic interests.
- Health Canada’s Public Release of Clinical Information (PRCI): Requires the removal of CBI before public disclosure of clinical information.
- FDA Transparency Initiatives: Encourage data sharing but emphasize the protection of trade secrets and confidential commercial information.U.S. Food and Drug Administration.
GenInvo’s CIS Tool: An Overview
The CIS Tool is designed to help organizations identify and manage CCI effectively.
Key Features:
- AI and Rule-Based Detection: Combines artificial intelligence with predefined rules to identify CCI across various documents.
- Comprehensive Category Coverage: Scans and extracts information across more than 50 categories, including dosage regimens and exploratory endpoints.
- Web and Document Scanning: Supports scanning of both web sources and documents (e.g., PDFs).
- User-Friendly Interface: Offers an intuitive interface for reviewing and managing identified CCI.
- Integration Capabilities: Can be combined with GenInvo’s Shadow™ for data anonymization and integrated with their Data Collaboration Platform for secure data sharing.
- Implementation Workflow
- Input Submission: Users upload documents or provide drugs/assets information for scanning.
- Automated Scanning: The tool analyzes content using AI and rule-based algorithms. Scanning on web can be performed within specific URLs or in google as well.
- CCI Identification: Potentially confidential information is flagged for review.
- Review and Validation: Users assess flagged content and confirm or adjust as necessary.
- Reporting: Generates reports and redacted documents for compliance and record-keeping.
Benefits for Life Sciences Organizations
- Regulatory Compliance: Ensures alignment with EMA, FDA, and Health Canada guidelines.
- Risk Mitigation: Reduces the likelihood of unintentional disclosure of sensitive information.
- Operational Efficiency: Automates the identification process, saving time and resources.
- Enhanced Collaboration: Facilitates secure data sharing with stakeholders while protecting CCI.
Conclusion
Protecting Confidential Company Information is crucial in the life sciences sector. GenInvo’s CIS Tool provides a robust solution to identify and manage CCI, ensuring organizations remain compliant with regulatory requirements while safeguarding their proprietary information.
