Marc Desgrousilliers explained how Clinovo leverages open-source technologies to complete Electronic Data Capture (EDC). He introduced Clinovo's newly revamped eClinical System: ClinCapture, the most advanced EDC system. Marc Desgrousilliers explains that “Clinovo uses open-source tools to reduce costs and accelerate processes in clinical trials. As opposed to proprietary software, the code of ClinCapture is completely free. Clinovo monetizes it by offering services including study build, validation, training, hosting, integration and support."
Open-source technologies allow everyone to access, use and distribute the code for free. Clinovo launched a forum to invite users and developers of ClinCapture to collaborate and participate to the system enhancement and product roadmap.
Marc believes that open-source is the future of clinical trials and that it is going to be mainstream in a few years. However he described the clinical trial industry as more conservative than other industries in regards to open-source. He emphasized the rigorous and methodical regulations and protocols in place explained by the number of lives at stake. Clinovo has tackled this by validating the open-source code, fully compliant with the FDA requirements. ClinCapture was validated following the "14-step hybrid validation model" based on risk analysis recommended by David Nettleton, one of the nation's foremost experts on Computer System Validation (CSV) for 21 CFR Part 11.
Marc explained how ClinCapture was designed to provide sponsor companies with the most intuitive and flexible EDC system. He claimed “this new release makes ClinCapture the most advanced open-source EDC system on the market. Our team worked tirelessly to provide an intuitive table navigation, reduce roles complexity, and give one-click access to many of the routine functions like scheduling events and data entry.”
Clinical trial professionals can try ClinCapture online on clinovo.com/clincapture and listen to or watch Marc's interview on mendelspod's website.
About Clinovo
Clinovo partners with life science companies to streamline their clinical trials, leveraging years of expertise in systems integration, open-source technology and industry standards. Clinovo provides Staffing Solutions, eClinical Systems and Biometrics Services including Clinical Data Management, Electronic Data Capture, CDISC mapping and SAS Programming. Clinovo also offers TechTrainings, a 10-week series of technical hands-on classes for clinical trial professionals to reach the next step in their professional career.
