eAdjudication® Software solution will help improve efficiency and data quality in the Endpoint Adjudication process.
BASEL (PRWEB) July 07, 2016
The Stanford Center for Clinical Research (SCCR), the academic research organization (ARO) housed within Stanford’s Department of Medicine, has adopted Ethical Clinical’s eAdjudication® cloud-based platform to manage the central assessment of clinical trial endpoints by an independent CEC (Clinical Endpoint Classification) committee.
“We are proud to work with SCCR on its mission to innovate and support high impact clinical research to improve human health,” said Mimmo Garibbo, Director of Ethical Clinical. “Our new eAdjudication® solution will help improve efficiency and data quality in the adjudication process."
Ethical Clinical designed eAdjudication® for AROs and CROs to enhance the endpoint adjudication services they provide to clinical trial sponsors. Users of the system include Uppsala Clinical Research Center, a top ARO based in Sweden.
Ethical Clinical’s adjudication solution provides access to a cloud-based platform that includes a rich array of integrated online tools to support the management of endpoint assessments and the submission of information packages to independent CEC committees. Committee members can complete their assessments by following a pre-defined and customized workflow. All tasks are performed within a quality-controlled and validated environment that has been designed to reduce the burden of the users through simple and streamlined processes and an easy-to-use software interface (smart phone or tablet enabled).
eAdjudication® is a cloud-based portal designed to support study leaders, central review committee members (e.g. DSMB, efficacy endpoint review), QA staff and sponsors across the whole adjudication process. Its main features include the management of data/documents related to events; management of the independent committee members; and endpoint assessments collection, reporting and data export. The portal is usually provided as a fully managed service including the hosting, technical management, validation (CSV/21 CFR Part 11 compliance), training and day-to-day technical support.
About Ethical Clinical
Ethical Clinical is based in Basel Switzerland and is exclusively focused on eClinical cloud software & services to support life science and drug development. The main solutions offered by Ethical include eAdjudication® for Clinical Endpoints Adjudication and e-Crf® for Clinical Trials Data Management. Ethical is owned by Italy-based GM Servizi, whose software solutions have supported 300 international trials with more than 10,000 investigational sites and hundreds of thousands of patients since 1997.