ACRES and Ethical GmbH, Switzerland to Collaborate on eAdjudication

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Ethical GmbH and the Alliance for Clinical Research Excellence and Safety (ACRES) join forces in improving Centralized Endpoint Adjudication - an essential element of drug development. An initial focus is developing standards for Adjudication Committee Charters, standard adjudication workflows and operating procedures to better align these across service providers, sponsors and members of adjudication committees.

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"Ethical GmbH and ACRES believe process efficiency, optimum utilization of scarce resources and data quality are critical for high quality clinical trials", comments Mimmo Garibbo, Director, Ethical GmbH.

Ethical GmbH, of Basel, Switzerland, a provider of Centralized Endpoint Adjudication solutions for clinical trials, and the Alliance for Clinical Research Excellence and Safety (ACRES), Cambridge, MA, a multi-sector non-profit organization building a multi-stakeholder-driven integrated global system for clinical research, today announced their strategic partnership.

This new collaboration, which brings Ethical GmbH into the ‘ACRES Alliance', a rapidly growing collaborative of innovation-focused organizations spanning the global clinical research enterprise, focuses on improving data quality and processes in clinical research by leading standardization efforts in Endpoint Adjudication in clinical trials.

Endpoint adjudication plays a key role in the approval of new therapies by regulatory authorities. However the current process is plagued by a lack of standards when dealing with existing subjective endpoints and the inconsistent use of independent review committees across disease states. Also, the conventional paper-based nature of endpoint adjudication adds to problems with time-consuming, inefficient and error-prone processes due to loss of adjudication dossiers or deficiencies in the endpoint adjudication decisions.

"Ethical GmbH and ACRES believe process efficiency, optimum utilization of scarce resources and data quality are critical for high quality clinical trials", comments Mimmo Garibbo, Director, Ethical GmbH. "As part of the ACRES Alliance and Technology Consortium, we can work together to address industry challenges and help eliminate tedious duplications resulting in higher costs and delayed availability of critically needed clinical trial data."

The collaboration will initially explore opportunities for streamlining and improving the Endpoint Adjudication process effectiveness. Ethical GmbH's Endpoint Adjudication solutions bring the Ethical eAdjudication® Platform to ACRES shared global platform of integrated technologies to improve the integrity of data and reduce trial costs. Ethical GmbH and ACRES will also explore development of shared standards across service providers, stakeholders managing Endpoint Adjudication Committees and sponsors. Ethical GmbH will participate in ACRES' Foundation Initiatives related to quality management, contributing to the “dynamic accreditation” process being developed by the Alliance.

The Ethical GmbH's eAdjudication® platform will give ACRES access to a fully validated system that provides an electronic “paperless workflow”, a role-based management of permissions and related workflows, the real-time, direct and controlled access to the study status, data, documents and adjudication decisions. In addition, the built-in quality control and metrics enables the users to exercise the oversight that GCP demands.

ACRES President and CEO, Dr. Greg Koski, said, "We are dedicated to developing an open-access global network of shared technology platforms, standards and processes to enhance performance, quality and safety in clinical trials through integration of existing innovative technologies. We are delighted to welcome Ethical GmbH. Together we can drive standards and aligned workflows to benefit all stakeholders, including sites, academic and commercial sponsors, CROs and, especially busy experts dedicating time and resources to the classification of clinical endpoint data that ultimately supports the work of regulatory agencies and is in the best interest of patients."

About eAdjudication
A cloud portal designed to support Study Leaders, Central Review Committee Members, Q.A. Staff and Sponsors across the whole adjudication process.

Main features include the management of: events-related data / documents; 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.

The Alliance for Clinical Research Excellence and Safety (ACRES) is a non-profit multi-sector alliance working in the public interest. It brings together diverse stakeholders across clinical research, harnesses their expertise to collaboratively build an open, integrated global system based in principles of Accountable Research™ and adapts lessons from industries that successfully implemented principles of systems and safety engineering, such as transportation, communications and information technology,

Mary F. Tobin, Ph D

Ethical GmbH
Ethical GmbH, based in Basel Switzerland, is exclusively focused on eClinical cloud software & services supporting life science & drug development. Solutions include eAdjudication for Clinical Endpoints Adjudication and e-Crf the eClinical platform for Electronic Data Capture, CTMS and Data Management.

Ethical is owned by GM Servizi, a software house based in Italy, supporting about 300 international trials with more than 10,000 investigational sites and hundreds of thousands patients with its software solutions.

Mimmo Garibbo
Ethical GmbH –

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