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eArchives (eTMF)

Electronic Trial Master File Management System

Secure and standardized file management system, effectively improving the timeliness, accuracy and completeness of clinical trial files.

eArchives is designed for the life science and pharmaceutical industries. As a secure cloud-based application, it supports the DIA reference model and complies with GCP regulations, covering all stages of clinical trial documents, including the generation, collection, approval, signing, archiving, QC, and etc. It helps clients to manage daily SOP documents and stay audit-ready all the time, significantly improving the efficiency and quality of file management.

eArchives improves the transparency of TMF quality, constructing a standardized procedure for TMF management


Abundant template resources, including standard TMF models, SOP models, file plan, incorporating with industry standardized DIA eTMF RM V3.0, ICH-GCP essential documents to quickly create projects of TMF index


Esential documents to quickly create projects of TMF index
Real-time archiving mechanism and real-time monitoring, collecting and processing files


Customized approval workflow, compliant with different enterprises’ SOP requirements


Diverse statistical charts and plots, data visualization