Source Document Manager

Clario Source Document Manager (SDM) is a secure, cloud-based application designed for clinical trial teams that need to collect, de-identify, translate, manage, and organize source documents. It provides a centralized location for document storage and processing, accessible from anywhere in the world, and is built to support compliance with 21 CFR Part 11 and EU GDPR requirements.

SDM is intended for research sites and trial management teams looking to reduce manual workload associated with source document handling. The platform combines software tools with optional redaction and translation services, and offers 24/7/365 live support via chat, phone, or email directly within the platform.

Core Capabilities

• Collects, processes, translates, and reviews source documents within a single platform
• Supports upload of PDFs and other allowed file formats into a defined folder structure
• Organizes uploaded documents into separate folders to streamline processing and querying
• Performs online PHI redaction at the site level, guided by an AI-based Protected Health Information detector
• Redaction quality control team reviews every page before a source document is made available
• Integrates directly with TransPerfect for language translation of source documents
• Tracks every click to maintain a full audit trail of all changes made during document processing

Platform Features

• Structured and guided data collection: The platform mirrors a trial's specific source document folder structure; documents can be set as required or optional, and guidance can be incorporated to help users determine which documents to collect
• Multilingual interface: The entire platform interface can be translated into local languages, supporting multiple languages across a single trial
• Language translation: Source document translation is handled through a direct integration with TransPerfect, with configurable turnaround times
• Complete audit trail: Unlike standard PDF redaction or offline review, SDM logs every action taken on a source document during processing
• User permissions: The system can be configured to allow multiple users to submit source documents simultaneously, or to restrict certain users to submitting only specific documents
• Query management: If a low-quality source image is uploaded, the SDM team queries the site and manages the reply process

Workflow Stages

1. Site-level upload and redaction of source documents
2. Translation, redaction quality control, and query management by the Clario team
3. Global trial management with centralized document access

SDM is deployed as a web-based application on a Global Cloud Network, making it accessible in any language from any location. The platform is designed to support regulatory compliance requirements including 21 CFR Part 11 and EU GDPR, with dedicated data QC technicians, data managers, and security teams supporting ongoing operations.