OpenClinica builds an eClinical SaaS platform for clinical trials, unifying Electronic Data Capture (EDC), eConsent, eCOA, randomization, EHR-to-EDC data integration, analytics and patient recruitment in a single cloud-hosted product. Founded in 2006, the company is the developer of what it describes as the world's first commercial open source clinical trial software, and its technical work spans open source software, cloud-hosted SaaS delivery and validated, compliance-oriented systems.
The company's platform addresses problems familiar to engineers who have worked in regulated data environments. Its stated aim is to reduce complexity in clinical trial technology without adding cost or heaviness - a philosophy born out of frustration with proprietary EDC software that was inflexible, expensive and difficult to consume. Automation of data acquisition is central to the approach: the platform is designed to move data directly from EHR systems into EDC rather than relying on manual entry.
Reported outcomes for study teams include launching studies in two to three weeks rather than three to six months, and 50% fewer data queries. The software is validated and compliant with 21 CFR Part 11, GCP and HIPAA standards, so engineering work is carried out in a regulatory context that shapes testing, documentation and release practices.
OpenClinica's customers include life sciences and pharmaceutical companies, CROs, academic research institutions and government agencies, with a stated focus on small to mid-size sponsors, CROs and academic teams. Further information is available at openclinica.com.
