Clario Source Document Manager (SDM) is a comprehensive, web-based application designed to revolutionize the management and organization of source documents for clinical trials. This secure platform enables the collection, de-identification, translation, and organization of source documents in a centralized location, accessible worldwide. SDM offers a user-friendly interface available in multiple languages, ensuring ease of use for global research sites. The system incorporates AI-based Protected Health Information (PHI) detection and redaction capabilities to maintain compliance with 21 CF...
Vendor
Clario
Company Website
Clario Source Document Manager (SDM) is a secure, web-based application designed to transform the management and organization of source documents for clinical trials. It offers a centralized platform for collecting, de-identifying, translating, and organizing source documents, making them accessible worldwide. The system features an intuitive interface, supports multiple languages, and incorporates AI-based PHI detection and redaction to ensure regulatory compliance. SDM streamlines the entire source document lifecycle, from upload to review, while providing robust security measures and comprehensive audit trails.
Key Features
Structured Data Collection SDM provides a flexible platform that mirrors specific source document folder structures.
- Customizable folder structure to match trial requirements
- Option to set documents as required or optional
- Incorporation of guidance for users on document collection
Multilingual Capabilities The platform supports multiple languages to facilitate global trials.
- Interface available in local languages
- Support for multiple languages across a single trial
- Integrated language translation services through Transperfect
Compliance and Security SDM ensures adherence to regulatory requirements and maintains data security.
- AI-based PHI detection and guided redaction
- 21 CFR Part 11 and EU GDPR compliance
- Complete audit trail of all changes made to source documents
Benefits
Improved Efficiency SDM streamlines source document management processes, saving time and resources.
- Centralized document storage and organization
- Elimination of time spent navigating lengthy PDFs
- Minimized workload for research sites and trial management teams
Enhanced Compliance The system helps maintain regulatory compliance throughout the document lifecycle.
- Guided PHI redaction process
- Redaction quality control by an expert team
- Comprehensive audit trails for all document interactions
Global Accessibility SDM enables worldwide access to source documents, facilitating international trials.
- Secure access from anywhere in the world
- Support for multiple languages and translations
- Cloud-based storage for long-term document retention