At Mobius Medical we primarily use OpenClinica open source EDC software. This means no licensing fees, you pay only for the database build and validation. We also provide a hosted solution, further reducing your costs.
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OpenClinica is powerful, industry leading open source software for capturing and managing clinical trial data. OpenClinica is the world’s most widely adopted clinical trial software technologies powering research in over 100 countries. OpenClinica is designed to be used in diverse types of clinical studies. OpenClinica supports Good Clinical Practice (GCP), regulatory guidelines such as 21 CFR Part 11, and is built on a modern architecture using leading open standards.
OpenClinica is web-based software, all your users require is a PC, browser, and internet connection.
OpenClinica Product Features
– Intuitive interface for subject enrolment, clinical data capture, validation, and query management.
– Organize your clinical research by study protocol and site, each with its own set of authorized users, subjects, study event definitions, and CRFs.
– Tools for data cleaning, clinical data management, and site monitoring.
– Support for sharing resources across studies in a secure manner.
– Custom define and obtain clinical datasets in real-time, and in a variety of formats.
– Dynamic generation of web-based CRFs for electronic data capture with validation logic defined in reusable templates.
– Design tools for configuring your study protocol: sites, eCRFs, edit checks/rules, users, and study event definitions.
– Rules engine performing advanced validation of study data and define automated actions within the system.
– Designate appropriate access for site-level and study-level users.
– A robust and scalable technology infrastructure developed using the Java J2EE framework and powerful PostgreSQL database.
– Tools for system oversight, audit-ing, configuration, and reporting.
– And much more