|Developer(s)||OpenClinica Developer Community|
|Initial release||December 23, 2005(1.0.0)|
[ (November 3, 2020 ) ±]
|Type||Laboratory informatics software|
|License(s)||GNU Lesser General Public License|
OpenClinica is free open-source clinical trials software that allows for the creation of studies and electronic case report forms as well as the capture and management of clinical data.
OpenClinica has its roots in Akaza Research, Inc., a bioinformatics company that began as a startup idea around 2004 and as an official business in May 2005. By then it had already released a beta preview release and was eying a June 2005 release of an official version 1.0 of their software, dubbed OpenClinica. Akaza's founders had collaborated with Mass General Hospital, the University of Connecticut, and Stanford University as early as two years prior after recognizing "the need to create an affordable, secure, and flexible software platform for conducting multi-site studies or protocols in diverse clinical research domains." Version 1.0 finally arrived on December 23, 2005, featuring improvements over its beta including a better interface, better documentation, and more robust querying tools. Five months later the company announced 1,000 copies of the free open-source application had been downloaded, growing to 3,000 by early November.
On November 15, 2006, version 2.0 was released, including upgrades to the software's data capture, study design and management, usability, and security features. By October 2008, Akaza was firmly extending its reach beyond the development of its software and into the fields of service and support, gaining official licensing as a National Cancer Institute support service provider for caBIG-related software, documentation, and training materials. A year later version 3.0 of OpenClinica was released, touted as an example of "how an open source community can produce superior software." In July 2010, Akaza announced its open-source community had surpassed 10,000 members while at the same time praising the open-source model, stating it "helps ensure that the product [OpenClinica] is well aligned with users' real-world needs."
For full release version history, refer to the project's list of project releases.
Features of OpenClinica include:
- create studies/projects
- clinical data capture, normalization, and validation
- query management
- role-based security
- administrative tools
- secure data sharing
- automated and manual data interchange
- follows 21 CFR Part 11 guidelines
- modular and extensible
Refer to the following:
Videos, screenshots, and other media
Entities using OpenClinica
- Franklin, Joshua D.; Guidry, Alicia; Brinkley, James F. (December 2011). "A partnership approach for Electronic Data Capture in small-scale clinical trials". Journal of Biomedical Informatics 44 (1): S103–S108. doi:10.1016/j.jbi.2011.05.008. http://www.sciencedirect.com/science/article/pii/S1532046411000992.
- "Releases for Download OpenClinica". OpenClinica, LLC. https://community.openclinica.com/node/5500/release?page=1. Retrieved 13 October 2012.
- "Final Release! OpenClinica 1.0 Now Available". OpenClinica, LLC. 23 December 2005. https://community.openclinica.com/content/final-release-openclinica-10-now-available. Retrieved 13 October 2012.
- McGee, Marianne Kolbasuk; Chabrow, Eric (18 October 2004). "Tech Employment Surges As Workforce Realigns". Information Week. http://www.informationweek.com/tech-employment-surges-as-workforce-real/50500227. Retrieved 13 October 2012.
- "Akaza Reasearch, Inc. Summary Screen". Commonwealth of Massachusetts. http://corp.sec.state.ma.us/corp/corpsearch/CorpSearchSummary.asp?ReadFromDB=True&UpdateAllowed=&FEIN=000894843. Retrieved 13 October 2012.
- "Akaza Research releases OpenClinica Beta Software, Professional Open Source Solution for the Academic Clinical Research Enterprise". OpenClinica, LLC. 9 March 2005. https://community.openclinica.com/content/akaza-research-releases-openclinica-beta-software-professional-open-source-solution-academic. Retrieved 13 October 2012.
- "Akaza Announces The 1,000th Download Of Java Based Clinical Trial Software". SYS-CON Media, Inc.. 24 May 2006. https://tv.sys-con.com/node/226567?page=0,1. Retrieved 13 October 2012.
- "Akaza Announces the 3,000th download of OpenClinica Open Source Clinical Trial Software". PRWeb. 3 November 2006. http://www.prweb.com/releases/2006/11/prweb469271.htm. Retrieved 13 October 2012.
- "OpenClinica 2.0 Now Available". OpenClinica, LLC. 15 November 2006. https://community.openclinica.com/content/openclinica-20-now-available. Retrieved 13 October 2012.
- "Akaza Research, LLC Becomes Licensed caBIG® Support Service Provider". PRWeb. 1 October 2008. http://www.prweb.com/releases/2008/10/prweb1401184.htm. Retrieved 13 October 2012.
- "Impact of Open Source on Clinical Trials Grows With Release of OpenClinica 3.0". OpenClinica, LLC. 14 October 2009. https://community.openclinica.com/impact-open-source-clinical-trials-grows-release-openclinica-30. Retrieved 13 October 2012.
- "OpenClinica Community Surpasses 10,000 Members". FierceMarkets. 7 July 2010. http://www.fiercebiotech.com/press-releases/openclinica-community-surpasses-10-000-members. Retrieved 13 October 2012.
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- "OpenClinica, LLC Summary Screen". Commonwealth of Massachusetts. http://corp.sec.state.ma.us/corp/corpsearch/CorpSearchSummary.asp?ReadFromDB=True&UpdateAllowed=&FEIN=001046526. Retrieved 13 October 2012.
- "OpenClinica Product Features". OpenClinica, LLC. https://www.openclinica.com/product-features. Retrieved 13 October 2012.