eArchives (eTMF)

eArchives (eTMF) is a Clinical Trial Document Management System developed by Taimei Technology, designed to streamline every stage of trial master file management — from document creation and approval through to archiving, quality control, and audit readiness. The platform is built for clinical operations teams seeking accurate, compliant records that meet international and regional regulatory standards, including ICH and NMPA GCP requirements.

With over 400 clients already adopted the solution and millions of documents managed, eArchives (eTMF) has demonstrated measurable impact on project efficiency across the life sciences industry.

DIA Reference Model Support and Compliant Directory Setup

• Supports the DIA eTMF Reference Model V3.2 as well as ICH and NMPA-GCP Essential Documents standards.
• Enables instant setup of GCP-compliant document directories aligned with ICH and NMPA requirements.
• Includes a library of standard TMF templates, SOP templates, and planning documents.
• One-click application for fast TMF Index creation, with dynamic adjustments to accommodate evolving trial needs.

System Tracking for Timely and Complete Document Collection

• Provides document tracking, timely task assignment, and continuous process monitoring throughout the trial lifecycle.
• Automated reminders for document collection help prevent omissions and delays.
• Mobile app configuration allows team members to quickly upload files via photo scanning for convenient, on-the-go document submission.
• SOPs for TMF management are built into the system to consistently boost TMF quality.

Flexible and Intelligent Document Management

• Customizable approval workflows can be configured to align with different enterprise SOPs and organizational requirements.
• Multi-dimensional reports provide real-time visual tracking of document status across the trial.
• Role-based access control ensures document security, with full traceability of all actions and changes.

Integration with eCooperate (CTMS)

• Seamless integration with Taimei's eCooperate (CTMS) platform reduces CRA document archiving workload by up to 40%.
• A single unified platform for both CTMS and eTMF documents eliminates duplicate copies stored across multiple locations.
• Reports processed within CTMS are automatically filed into the corresponding eTMF project folder, reducing manual effort for Clinical Research Associates.

eArchives (eTMF) is part of Taimei Technology's broader clinical operations suite, which also includes eCooperate (CTMS), eCollect (EDC), eCollege, and eSafety. The platform is designed to support compliant, audit-ready trial documentation at scale for global and regional clinical development programs.