Anju Introduces eTMF Master for Electronic Trial Master File Management in Clinical Studies

Anju announced the introduction of eTMF Master, a new cloud-based electronic trial master file software product. The solution facilitates collaboration between sponsors, CROs and sites to efficiently and securely manage clinical trial content in a regulatory-compliant environment.

eTMF Master allows faster compilation of clinical trial-sourced digital documents and images to meet increasing regulatory requirements and deadlines for agency inspections, sponsor audits and internal audits. The system supports the standard Trial Master File (TMF) Reference Model for defining clinical trial master file records. Built on Anju’s enterprise content management technology, eTMF Master provides powerful search and workflow capabilities and support for planned integrations with Anju and third-party eClinical systems.

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“With clinical studies becoming more complex and stakeholders responsible for tracking and reporting rapidly multiplying trial-related content, the industry is asking for more efficient regulatory-compliant processes to create and manage essential trial content,” said Debashish Niyogi, Ph.D., Anju’s Director of Product Management-eTMF. “As the latest addition to our eClinical suite, we designed eTMF Master so sponsors, CROs and sites working on a clinical trial anywhere in the world can collaborate with each other and quickly collect and manage all their content in one system to help ensure that no information about that trial is ever missing.”

eTMF Master provides organizations with reduced business risk, enhanced artifact quality, and decreased auditing and reporting costs all while improving team communication and productivity. Access controls, data integrity and regulatory compliance features ensure that the electronic master file is always audit-ready, while artifact quality is improved through defined workflows and automated quality control processes. Anju’s eTMF reduces costs often found with manual paper-based and legacy clinical trial record-keeping systems by providing rapid implementation and configuration, actionable insights, and flexible search capabilities.

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