OpenClinica is a web-based software tool designed to capture clinical study data. The standard way to capture data in clinical studies is via Case Report Forms (CRF) which are specifically designed to collect study data in a structured format. The sponsor of the study is responsible for designing CRFs that accurately represent the protocol of the clinical study, as well as managing their production, monitoring data collection and auditing the content of the completed CRFs.
OpenClinica is a TraIT managed tool that allows sponsors (or their delegates) to design and manage study specific electronic CRFs. OpenClinica CRFs can be completed for all participating subjects and can be reached from various locations in the world, allowing OpenClinica to be used for multi center studies.
OpenClinica is the world's first commercial open source clinical trial software for Electronic Data Capture (EDC) Clinical Data Management (CDM).
OpenClinica has two editions: Community and Enterprise. The OpenClinica Community edition is freely available for all to use and the OpenClinica Enterprise edition has additional capabilities and is commercially supported and subject to a license fee.
The advantage of the Open Source model compared to a propriety model, is that multiple independent contributors can review the source code, making enhancements which are then added to the version available to the entire OpenClinica community. This external review possibility increases the quality of the software based on the ‘many-eyes’ principle. TraIT has contributed a number of enhancements and bugs fixes to the OpenClinica code. A user forum is available where users can ask questions, submit suggestions for improvements, and report issues ( https://forums.openclinica.com). The company which originally developed OpenClinica (OpenClinica LLC) uses a mixed business model; the source-code is Open Source while professional support and hosting of the enterprise edition generates revenues.
In just a few years since its first release, OpenClinica became one of the world's most widely adopted clinical trial software technologies powering clinical research in over 100 countries. During this time, a rich community of innovation has arisen around OpenClinica making it both a robust and uniquely flexible platform used across diverse types of clinical research.
Some features of OpenClinica:
- Open Source license
- Web based
- Supports all types of clinical studies
- No programming/ IT knowledge needed for CRF design
- Built on leading, independent standards
See also (https://www.openclinica.com/about)