Life Sciences VirtualWaltham, MA
OpenClinica provides a cloud-based platform for study design, electronic data capture (EDC), electronic patient-reported outcomes (ePRO), randomization, graphical reporting, and coding, empowering clinical data managers to take full control of their studies and collect better data, faster. A modern UX and ultra-capable forms engage patients right on their own device while spurring more timely, accurate data entry from sites. Powerful APIs and e-source readiness make OpenClinica the data management solution of choice for today's complex trials.
If you can dream it, you can design it. From straightforward Phase II's to adaptive, multi-arm post-marketing trials, OpenClinica is the ideal choice for all research paradigms (and settings). You can order your events to accommodate any level of complexity, and build forms elegant enough for smart-phone based ePRO and sophisticated enough for the savviest clinical research coordinator. We've yet to meet a randomization scheme we couldn't build right into our EDC. And reporting? Ask your question once, and get real-time, visual answers as often as you need with OpenClinica Insight.
A data capture and management system needs to have standards, doesn't it? We adhere to what is arguably the most universal: the CDISC ODM.
The Clinical Data Interchange Standards Consortium (CDISC) is a clinical research standards body formed to encourage maximum sharing of information and minimum duplication of efforts. CDISC's Operational Data Model (ODM) facilitates the archive and interchange of the metadata and data for clinical research. The bottom line? From the moment it's captured, your OpenClinica study data speaks a worldwide language enabling it to "talk" with datasets from other domains, like genomic and imaging surveys, for more powerful results.
When it comes to regulation, you either go the extra mile, or you fall short. We've always chosen to do more to ensure the security of our system, the sanctity of your data, and the privacy of research participants. Every component of our cloud-hosted platform meets or exceeds the current regulations mandated by the FDA and EMA. We comply with HIPAA, 21 CFR Part 11, ICH GCP, and GDPR. Plus, we support an on-demand library of testing results to support the essential role our customers play in validation.
We are constantly looking at ways to make it possible (not to mention reliable and easy!) for users and developers to interact with and extend OpenClinica in a programmatic way. This can mean anything from data loading to more meaningful integrations of applications common to the clinical research environment.
By offering a well-documented web services API, OpenClinica makes it easy for its users to leverage RESTful web services, together with OAuth protocol version 2.0, to systematically:
- extract data from almost any third-party source (e.g. labs and imaging centers)
- associate each element of that data to the relevant Case Report Form (CRF) field.