Ethical eAdjudication ® selected by Uppsala Clinical Research Center (UCR) to Support Clinical Endpoint Adjudication
BASEL, SWITZERLAND - June 18, 2014
Uppsala Clinical Research Center (UCR), a top Academic Research Organization based in Sweden, adopted Ethical eAdjudication® cloud-based platform to manage the central assessment of Clinical Trial Endpoints by an independent CEC (Clinical Endpoint Classification) Committee.
“We are really proud that our new Endpoint Adjudication solution will help UCR to improve efficiency while keeping the high quality in the Adjudication procedures" said Mimmo Garibbo, Director of Ethical GmbH.
UCR has decided to use the eAdjudication platform for a large global cardiovascular trial (17.000 patients) but will also use the system for other Trials both Academic and Pharmaceutical in different therapeutic areas.
By adopting Ethical’s adjudication solution UCR staff has access to a cloud-based platform that includes a rich array of integrated online tools to support the management of endpoints assessments and the submission of information packages to the independent CEC Committee.
The Committee members will be able to complete their assessments by following a pre-defined workflow. All tasks are performed within a quality-controlled environment that has been designed to reduce the burden of the users through a streamlined process and an easy to use software interface (smart-phone or tablet enabled).
“By using eAdjudication solution the Endpoint Adjudication Process can be managed 100% by the web based system, without any paperwork.
All documentation and information will easily be managed within the system.
The CEC members can log in to eAdjudication at any time and at any place.
This is very efficient and we can have a great overview of the event status, submission and adjudication”, said Ulrika Bodén Team leader of the CEC department at UCR.
a cloud portal designed to support Study Leaders, Central Review Committee Members (e.g. DSMB, efficacy endpoint review), Q.A. Staff and Sponsors across the whole endpoint adjudication process.
Main features include the MANAGEMENT OF DATA / DOCUMENTs related to EVENTs, MANAGEMENT OF THE INDEPENDENT COMMITTEE MEMBERS, ENDPOINT ASSESSMENTS COLLECTION, REPORTING & 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 & day-to-day technical support.
Uppsala Clinical Research Center (UCR) is a non-profit academic clinical research organisation providing services to academic researchers and pharmaceutical and medtech companies in Sweden and internationally. UCR is an independent entity within Uppsala University and Uppsala University Hospital. UCR offers all services needed to conduct a clinical study, from protocol to clinical report, having special expertise in adjudication of clinical events (Clinical Endpoint Classification). UCR was Sweden’s first center for National Quality Registries and is, as the host of approximately 20 national quality registries, a leading organization for quality control and evaluation of new therapies in Swedish health care. UCR also includes Uppsala Biobank with infrastructure for collection and storage of biological materials and UCR Laboratory, an accredited biomarker laboratory.
ABOUT ETHICAL GMBH
Ethical GmbH is a company, based in Basel Switzerland, exclusively focused on eClinical cloud software & services to support life science & drug development. Main solutions offered by Ethical include eAdjudication for Clinical Endpoints Adjudication and e-Crf the eClinical platform for Electronic Data Capture, CTMS and Data Management. Ethical is a startup owned by GM Servizi, a software house based in Italy, that since 1997 is supporting with its software solutions about 300 international trials with more than 10,000 investigational sites and hundreds of thousands patients.
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