Your Shield To Confidential Information for Regulatory Compliance, Economic Risks and Data Breaches.
Your Shield To Confidential Information for Regulatory Compliance, Economic Risks and Data Breaches.
CIS Product Videos
CIS™
AI-Powered CCI Redaction Tool for Regulatory Compliance & Data Protection in Clinical Trials
CIS™ is an AI-powered solution that safeguards commercially confidential information (CCI) in anonymized clinical documents and ensures compliance with global regulatory standards. Built specifically for the life sciences industry, CIS™ combines Artificial Intelligence and Machine Learning to accurately detect, classify, and protect confidential data and information across documents and repositories.
Traditional manual redaction and homegrown utilities are slow, error-prone, and unable to keep pace with regulatory requirements eg. EU-Clinical Trial Regulation, EMA Policy 0070, Health Canada Public Release of Clinical Information etc. CIS™ changes that by delivering automated, intelligent scanning across 50+ life sciences specific categories of confidential information, enabling faster, more reliable protection of data in regulatory submissions, clinical trial documents, and research records.
With seamless integration into document repositories and scanning across custom portals, CIS™ provides a centralized, secure way to manage and protect sensitive information throughout its lifecycle. Whether it’s meeting EMA Policy 0070, Health Canada MR001-MR004, HIPAA, GDPR, or 21 CFR Part 11 requirements, CIS™ empowers organizations to stay compliant while focusing on science, innovation, and results.
By leveraging sophisticated hybrid AI algorithms, CIS™ not only reduces compliance risks but also strengthens regulatory guidance on CCI, enhances data security, and preserves organizational trust in a complex data transparency landscape.
GenInvo’s CIS Tool is an advanced AI-driven solution that efficiently uncovers confidential business information over web and in publicly available documents, covering over 100 standard categories. Combine it with Shadow to remove sensitive identifiers and use our Data Collaboration Platform to share your processed data with confidence.
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A very user friendly and robust tool which helps on finding the publically available information on more than 50+ categories like Dosage & Regimen, Storage Information, Explorary Endpoints etc.
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Runs on rule based and AI model-based algorithms to find the company confidential informations.
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Supports web scan as well as document scans (pdf)
Key Features
CIS™ is a fully featured, user-friendly, compliance-driven solution built to protect confidential and sensitive information during the clinical development of the drug molecule while maintaining compliance with data-sharing regulations.
- 50+ Confidentiality Categories across drug discovery, development, and regulatory workflows.
- Customized Scanning across internal repositories, web sources, and regulatory documents.
- Automated Re-Scanning to detect updates and ensure continued protection of confidential information.
- Document Scanning for internal documents, clinical trial reports, and regulatory submission.
- Reports that generates human-like, well-structured outputs for review and compliance records of CCI management.
- CCI Source Navigation to quickly locate the exact page, section, or PDF where confidential information is identified.
Category Features
Track and safeguard sensitive commercial information, payment agreements and confidentiality clauses with precision. CIS™ ensures contractual obligations remain protected and compliant with industry regulations.
Protect critical study timelines, trial milestones, and projected development dates from unintended disclosure. CIS™ keeps your strategic plans secure while maintaining transparency where required.
Confidential details about research facilities, labs, and third-party vendors are securely scanned and monitored. CIS™ helps you protect sensitive operational data without slowing collaboration.
Safeguard asset pipelines and study-related details throughout the drug development lifecycle. With CIS™, sensitive asset intelligence remains secure across internal and external exchanges.
When your studies involve sponsor medicines or vaccines in combination or as comparators, CIS™ protects this sensitive information from exposure. This reduces risks of competitive intelligence leaks.
Confidential references to non-sponsor drugs or vaccines in trials or comparative studies are scanned and secured. CIS™ ensures protection while preserving regulatory clarity in submissions.
CIS™ identifies and protects confidential information in sponsor-backed studies, from protocols to trial results. This safeguards sponsor interests while supporting compliance across submissions.
Protect sensitive details in multi-sponsor or collaborative research projects with ease. CIS™ ensures that confidentiality obligations are honoured without slowing down innovation.
The Latest Industry Breakthrough
Looking to enhance your organization’s impact? GENINVO’s technology-empowered experts are available to assist you in the following areas:
Industry-Specific Confidentiality Categories
CIS™ comes preloaded with 50+ categories tailored for life sciences, covering every stage from drug discovery to regulatory submission. This ensures you capture the right confidential elements, no matter where you are in the development lifecycle.
Customized Scanning Across Sources
Easily configure CIS™ to scan across internal repositories, regulatory portals, and the open web information. Flexible customization means the tool adapts to your specific workflows, not the other way around.
Automated Re-Scanning for Updates
Stay ahead of evolving compliance requirements with scheduled and automated re-scanning. CIS™ continuously checks for updates, ensuring your data remains protected and compliant over time.
Intelligent Document Scanning
CIS™ scans clinical trial reports, submissions, and internal documents with AI-powered precision. It reduces manual effort and minimizes the risk of overlooking sensitive information.
Customizable Reporting
Generate well-formatted Excel reports that present findings clearly for compliance and audit teams. Designed to look natural and easy to review, reports save time and speed up decision-making.
Source Navigation Made Simple
Pinpoint confidential information instantly with CCI source navigation, linking directly to the page, section, or PDF where data was found. This transparency builds confidence and streamlines the review process.
Centralized CCI Database for Redactions
Leverage the Asset CCI Database to apply consistent redactions across all documents. By storing and reusing CCI intelligence, CIS™ ensures efficiency and compliance in every project.
How Web Scan Works
- System is provided with drug and optional sponsor name.
- System will then initiate a web scan on the basis of provided drug and sponsor name for several CIS categories.
- Some examples of categories are dosage and regimens, storage Information, exploratory endpoints etc.
- The extracted information will be part of repository for quick search and load of the web data.
- User can reinitiate web scan if needed.
Document Scan
- User can upload documents for drug and optional sponsors.
- System will then initiate scan of those documents for needed categories.
- User will be able to view the results per documents.
- User can upload additional documents and rerun scan.
- User will be able to link the search items in the pdf document loaded on the tool itself.
