Clinical Research

  • OpenClinica
    http://www.openclinica.org

    OpenClinica is a free, open source clinical trial software platform for Electronic Data Capture (EDC) clinical data management in clinical research. The software is web-based and designed to support all types of clinical studies in diverse research settings. From the ground up, OpenClinica is built on leading, independent standards to achieve high levels of interoperability and regulatory compliance. Its modular architecture and transparent, collaborative development model offer outstanding flexibility while supporting a robust, enterprise class, regulatory compliant, solution.

    The OpenClinica software platform supports:

    * Management of numerous, diverse clinical studies through a unified interface
    * Clinical data submission, validation, and annotation
    * Data filtering and extraction
    * Study oversight, auditing, and reporting

    OpenClinica facilitates study protocol configuration, data collection via electronic case report forms (eCRFs), and enables productive clinical trials management. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulator guidelines and is designed as a lightweight, standards-based, extensible, and modular platform. OpenClinica’s open source pricing model facilities a dramatically lower cost of use and ownership than proprietary, closed EDC and data management systems. All versions of OpenClinica are available for free download from http://www.openclinica.org.

    OpenClinica is released under the LGPL open source license. The product is commercially supported by Akaza Research to facilitate enterprise-level use.