临床研究管理平台

AuroraPrime Catalog

Saas-based eTMF System

Built on top of the AuroraPrime Clinical Research Platform, Prime Catalog is an electronic Master Trial File (eTMF) system for managing essential clinical trial documents and contents. Prime Catalog not only provides GCP-compliant Trial Master File (TMF) Reference Model, access control, and review workflow templates for quick system setup, but also provides the ability to review and archive all types of documents related to clinical trials, which can be auto-filed in conjunction with other product modules on the AuroraPrime platform. With Prime Catalog, site users can scan and auto-generate PDF documents on the mobile APP, and all study roles can leverage NLP-based filing recommendation efficiently organize and manage essential clinical documents. The configurable QC mechanism and regular quality control sampling design, combined with audit trail, can help organizations achieve high quality management of complete trial master file.

Modules
Features
Benefits

System Configuration

Prime Catalog provides multiple sets of catalog templates based on the TMF reference model, with a full set of built-in document review processes and user access control settings to precisely define the document workflow. Meanwhile, Prime Catalog features convenient batch processing functionality that eliminates repetitive manual operations, drastically cutting back on system setup time while ensuring compliance.
Document Management

Prime Catalog provides a fast, full-fledged document collection and filing experience at research sites, where CRAs and other roles can take photos, desensitize, generate PDF documents, and upload them all at once from their mobile devices. Electronic documents can be quickly uploaded to corresponding directories in the system. From document upload to final review, Prime Catalog intelligently drives the entire document lifecycle, from document auto-naming, configurable approval workflow, accurate path allocation, to data insight and feedback. Aurora clinical logic engine provides users with intelligent management recommendations at the user's discretion, avoiding operational errors, and improving the document management process.
Document Quality Control

Prime Catalog provides complete configurable work and audit workflow, allowing users to perform various types of quality control, including file checking, spot-checking, auditing, final checking, electronic signature, etc. It supports multiple spot-checking modes such as by time and by proportion. Complete audit trails are recorded to ensure regulatory compliance.
Catalog Structure Template

Based on the TMF Reference Model, the system provides multiple sets of standard document directory structure templates with built-in document approval process and user access control. The templates provide intelligent placeholders based on the content and nature of the documents, which manage documents in a precise and holistic manner.
Batch Access Control Configuration

The system supports access control configuration in batches, which allows recursive application of a folder's access permissions to all its sub-folders, eliminating the trouble of configuring permissions for a large number of folders.
File Scanning on Mobile

Scanned files are automatically desensitized and saved to be uploaded to the staging area to be further filed to the target folder.
Staging Area

A staging area is available for users to store uploaded files conveniently, and can be shared to other users to facilitate collaboration.
Intelligent Recommendation

Target directory recommendations are provided based on intelligent algorithms, which can be overriden by the user to improve filing accuracy.
My Todos

According to the document management workflow, the user's related tasks will be prompted in "My Todos", and the user can filter the tasks according to the task type, while the system supports batch processing of documents to improve the efficiency of document management.
Dashboard

The system has built-in action trigger nodes, which provide multi-dimensional data based on document processing, including overall information, progress status, quality and efficiency metrics. In addition, the dashboard presents data indicators to users in the most concise way through various visualization methods.
Data Interoperability

The system provides interfaces to other AuroraPrime products as well as external systems to facilitate efficient data transmission and interoperability.
Audit Trail

All key operations in the system are recorded with a complete audit trail to meet regulatory compliance requirements. At the same time, the system supports users' filtering and exporting of audit traces to achieve accurate retention of system operation traces.
Fast System Setup

Prime Catalog reduces the time required for system go-live, whether it is document directory templates, document permissions and approval flow configuration, or every feature that ensures compliance.
Improve Efficiency and Quality of Document Management

Prime Catalog supports subsequent assignment of documents in the staging area by multiple users to complete efficient processing of documents. In addition, the system provides configurable and standardized workflows and document permissions to help users manage documents efficiently and with high quality; the system provides a concise data dashboard for real-time visibility. The system's parallel web-based and mobile applications enable users to manage documents in real time from different devices.
Provide users with knowledge insight and action guidance

Prime Catalog's intelligent drive runs through the whole process of file management, from automatic data desensitization during file collection, to intelligent naming of uploaded files, intelligent recommendation of the most suitable folder, and data collection and monitoring for the file management process. Based on intelligent algorithms, the system achieves knowledge insight based on multiple dimensions such as progress, quality and efficiency, and provides action guidance to users.
Open System with Data Interoperability

Prime Catalog supports the integration of internal and external systems. For internal systems, Prime Catalog is seamlessly integrated with other AuroraPrime products to with efficient and standardized transmission of documents and information, streamlining the workflow. For external systems, Prime Catalog provides interfaces for data interoperability.

Modules

System Configuration

Prime Catalog provides multiple sets of catalog templates based on the TMF reference model, with a full set of built-in document review processes and user access control settings to precisely define the document workflow. Meanwhile, Prime Catalog features convenient batch processing functionality that eliminates repetitive manual operations, drastically cutting back on system setup time while ensuring compliance.
Document Management

Prime Catalog provides a fast, full-fledged document collection and filing experience at research sites, where CRAs and other roles can take photos, desensitize, generate PDF documents, and upload them all at once from their mobile devices. Electronic documents can be quickly uploaded to corresponding directories in the system. From document upload to final review, Prime Catalog intelligently drives the entire document lifecycle, from document auto-naming, configurable approval workflow, accurate path allocation, to data insight and feedback. Aurora clinical logic engine provides users with intelligent management recommendations at the user's discretion, avoiding operational errors, and improving the document management process.
Document Quality Control

Prime Catalog provides complete configurable work and audit workflow, allowing users to perform various types of quality control, including file checking, spot-checking, auditing, final checking, electronic signature, etc. It supports multiple spot-checking modes such as by time and by proportion. Complete audit trails are recorded to ensure regulatory compliance.

Features

Catalog Structure Template

Based on the TMF Reference Model, the system provides multiple sets of standard document directory structure templates with built-in document approval process and user access control. The templates provide intelligent placeholders based on the content and nature of the documents, which manage documents in a precise and holistic manner.
Batch Access Control Configuration

The system supports access control configuration in batches, which allows recursive application of a folder's access permissions to all its sub-folders, eliminating the trouble of configuring permissions for a large number of folders.
File Scanning on Mobile

Scanned files are automatically desensitized and saved to be uploaded to the staging area to be further filed to the target folder.
Staging Area

A staging area is available for users to store uploaded files conveniently, and can be shared to other users to facilitate collaboration.
Intelligent Recommendation

Target directory recommendations are provided based on intelligent algorithms, which can be overriden by the user to improve filing accuracy.
My Todos

According to the document management workflow, the user's related tasks will be prompted in "My Todos", and the user can filter the tasks according to the task type, while the system supports batch processing of documents to improve the efficiency of document management.
Dashboard

The system has built-in action trigger nodes, which provide multi-dimensional data based on document processing, including overall information, progress status, quality and efficiency metrics. In addition, the dashboard presents data indicators to users in the most concise way through various visualization methods.
Data Interoperability

The system provides interfaces to other AuroraPrime products as well as external systems to facilitate efficient data transmission and interoperability.
Audit Trail

All key operations in the system are recorded with a complete audit trail to meet regulatory compliance requirements. At the same time, the system supports users' filtering and exporting of audit traces to achieve accurate retention of system operation traces.

Benefits

Fast System Setup

Prime Catalog reduces the time required for system go-live, whether it is document directory templates, document permissions and approval flow configuration, or every feature that ensures compliance.
Improve Efficiency and Quality of Document Management

Prime Catalog supports subsequent assignment of documents in the staging area by multiple users to complete efficient processing of documents. In addition, the system provides configurable and standardized workflows and document permissions to help users manage documents efficiently and with high quality; the system provides a concise data dashboard for real-time visibility. The system's parallel web-based and mobile applications enable users to manage documents in real time from different devices.
Provide users with knowledge insight and action guidance

Prime Catalog's intelligent drive runs through the whole process of file management, from automatic data desensitization during file collection, to intelligent naming of uploaded files, intelligent recommendation of the most suitable folder, and data collection and monitoring for the file management process. Based on intelligent algorithms, the system achieves knowledge insight based on multiple dimensions such as progress, quality and efficiency, and provides action guidance to users.
Open System with Data Interoperability

Prime Catalog supports the integration of internal and external systems. For internal systems, Prime Catalog is seamlessly integrated with other AuroraPrime products to with efficient and standardized transmission of documents and information, streamlining the workflow. For external systems, Prime Catalog provides interfaces for data interoperability.