eTMF
Modern Content Management
eTMF
Our eTMF module provides DIA-reference model-based management of the documentation for trials, with missing document reports, automations for site and trial setup and an investigator or site portal. Our eTMF system is seamlessly connected to CTMS as it's all based on a single information lake and it can also be integrated with external systems.
Standard eTMF document features
Manage the creation, review, and approval (including eSignature), of eTMF documents using the DIA Reference Model. Use our master data dictionaries for industry picklists and product or study data
Automations
The power of an eTMF system is in the automations and solving pain points – for example, eTMF is seamlessly connected to CTMS as it's all based on a single information lake (or can be integrated with external systems), automated site and trial plan setup, and easy de-duplication of documents
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Investigator and Site Portal
Use the simplified CARA Portal for sites and investigators to access and upload eTMF content, and work on content during collaboration, without the need to involve IT in setting up network IDs
Metrics & Analytics
CARA provides an extensive dashboard and analytics capability, which allows management to track things like the status by country, site, or study, metrics over a particular time period, as well as the all-important “Missing Documents Report”. All dashboards in CARA provide clickable graphs, which show you the items or documents that make up the data points on the graph
