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Prime Catalog is a software system for clinical trial document management throughout the entire trial process on the AuroraPrime clinical research platform. Prime Catalog provides GCP-compliant eTMF functionality for clinical trials, including the Trial Master File (TMF) Reference Model directory structure, permissions, and audit flow templates that can be quickly configured and used in the system. For scenarios where data is scanned and uploaded in the research center, Prime Catalog supports scanning and automatic merging into PDFs on the mobile app, and NLP-based archiving directory recommendation functions which improve the efficiency of document management across various departments of clinical trials. Configurable QC mechanisms and periodic quality control sampling designs, along with complete inspection trail, help enterprises achieve high-quality management of complete clinical trial documents.

In addition to eTMF functionality, Prime Catalog also provides approval, review, and archiving functions for various clinical trial-related documents, including archiving in eTMF directories, project public discs, and enterprise public discs, ensuring that trial-related documents can be efficiently and compliantly managed. This improves overall document collaboration efficiency within the enterprise and also improves document collaboration efficiency for sponsors, CROs, and sites.

Furthermore, Prime Catalog supports open interfaces and internal automatic archiving mechanisms, making it easy for external systems and other AuroraPrime products to automatically archive various types of documents.

Advantages

Shorten System Preparation Time for Deployment

Improve Document Management Efficiency and Quality

Provide Users with Knowledge Insights and Action Guidance

Convenient System Integration

More Compliant and Efficient-process Document Management

Key Features

Directory Structure Template

The system provides Chinese and English file directory structure templates based on the CDISC TMF Reference Model.

Batch Permission Configuration

The system supports batch configuration of permissions, eliminating the need for users to configure permissions for a large number of folders.

Mobile App - File Scanning

The app provides an intelligent file scanning function that automatically performs de-identification processing on files, saves them as documents, and uploads them to the system's temporary storage area.

Temporary Storage for Files

The system's temporary storage allows users to easily store uploaded files and share them with other users.

Intelligent Recommendation

The system provides target directory recommendation based on intelligent algorithm for file allocation scenario.

My To-do List

Relevant tasks will be displayed in "My to-do list".

Data Dashboard

The system provides various data information based on user file operations and includes multiple action trigger nodes.

Open Interface

Seamless integration with other products on the AuroraPrime clinical research platform, and supports access interfaces for external system files.

Project-level Public Disc

The system provides a project-level public disc, allowing for compliant and efficient management of documents during the trial process or non-eTMF documents.

Inspection Trail

The system records a complete inspection trail of all critical operations.

Improve the efficiency of clinical research and development and
bring innovative products to market faster.

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