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.