Case Study: Academic Research Organisation achieves compliant, scalable endpoint adjudication with Ethical GmbH eAdjudication®

Eadjudication In Support Of An Aro Newly Engaged In Endpoint Adjudication

Academic Research Organisation, a small EU-based ARO with little experience in clinical adjudication, needed help setting up a compliant and reliable endpoint adjudication process for a Phase III cardiology study run across Sweden and the US. Vendor Ethical GmbH was engaged to provide the expertise and tool needed, including its eAdjudication® platform.

Ethical GmbH implemented a GCP-compliant workflow using eAdjudication® to collect source documents from sites, manage queries, and generate an FDA-compliant PDF package for submission and archival. The team also provided best-practice guidance and a scalable, multi-study setup, helping the ARO run adjudication efficiently and compliantly; while no hard metrics were given, the customer said the solution was “perfect” and praised the exceptional support from Ethical GmbH.