eTMF
Modern Content Management
Streamline Clinical Trials with Connected eTMF & CTMS
Our eTMF module simplifies trial documentation with DIA-reference model alignment, automated site and trial setup, and an integrated site portal. Seamlessly connected to CTMS through a unified data lake, it also supports integration with external systems.
Our CTMS serves as the single source of truth for all operational trial data—empowering managers with real-time insights across study and site initiation, patient recruitment, monitoring, and drug supply.
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
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
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