The LibreClinica project was founded in 2019 to work on an open source electronic data capture (EDC) system for clinical trials based on the OpenClinica(R) (OC) 3 community edition. OC3 offers a good range of functions, and has many users worldwide. With the advent of OC4, to date (Feb 2019) there is no community version announced. Thus, to keep alive the work contributed by OpenClinica(R) to the community, the LibreClinica project aims to
- clean up the build process offering a version that can be built independently of OpenClinica-servers
- provide a version that can be built compatible for recent versions of JDK, Tomcat, and PostgreSQL
- provide minor releases / subversions for bug fixes
- provide a free to use version
- improve code quality
- improve and extend functionality
- generate ideas for next generation EDC system
- The project is to be open source valueing input from contributors, and at the same time providing a reasonably tested production version.
The project started with volunteers from different background, i. e. academia, clinical research service, IT industry.
- ReliaTec GmbH, a German IT company with 10+ years of experience tailoring and supporting OpenClinica systems to the needs of their customers from academia and industry, provides the organisational framework such as website, trademark registration, project coordination, and last but not least code. ReliaTec also offers validation of LibreClinica installations to meet the requirements in Good Clinical Practice (GCP) and otherwise regulated environments.
- DKFZ Partner Site Dresden, member of the German Cancer Consortium (DKTK). The translation centre of DKTK partner site Dresden was established jointly by the University Hospital Carl Gustav Carus at the Technische Universität Dresden, Institution under public law of the free state of Saxony (UKD). The project LibreClinica was developed in cooperation with scientists of the German Cancer Consortium.
- GCP-Service International, a Contract Research Organisation with more than 15 years of experience in conducting clinical studies with pharmaceuticals and medical devices for biotech and medical device as well as academic healthcare organisations. The team of GCP-Service always wanted to provide the highest value to sponsors and investigators by focusing the development on innovative processes, well competent people and cost effective IT solutions. GCP-Service supports the validation of LibreClinica on application level to meet the requirements in regulated environments.