OpenClinica

OpenClinica, founded in 2006, makes eClinical software for running clinical trials. Its cloud-hosted platform brings together Electronic Data Capture (EDC), eConsent, eCOA, randomisation, EHR-to-EDC integration, analytics and patient recruitment in a single validated system. The approach is intended to accelerate trials by automating data acquisition rather than by adding staff to process it.

The company describes its product as the world's first commercial open source clinical trial software. That lineage traces to its founding, which was prompted by dissatisfaction with proprietary EDC software seen as inflexible, expensive and hard to adopt. OpenClinica positions itself for small to mid-size sponsors, contract research organisations and academic teams, aiming to reduce complexity without excess cost or heaviness. Its stated metrics include study start-up in two to three weeks rather than three to six months, and around 50% fewer data queries.

The software is built for regulated work: the technical domains span 21 CFR Part 11, Good Clinical Practice and HIPAA compliance. Customers and users sit across life sciences, pharmaceuticals, clinical research, healthcare, academic research and government agencies.