Phase III cardiology study (2017). Small-sized, EU-based Academic Research Organisation (ARO) with little experience in clinical adjudication is looking for a strong partner with the expertise and tool to help them set up a compliant, reliable endpoint adjudication process.
CLIENT
ARO (Small size, EU-based)
DISEASE AREA
Cardiology
YEAR INITIATED
2017
STUDY INFORMATION
Phase III
Executed in Europe and US
2 countries (Sweden and US) – 78 sites – 2,000 subjects
REQUIREMENTS
- To implement a GCP-compliant tool able to provide audit-trail
- To receive best-practice guidance to set up an efficient workflow, including for collecting source documents from sites
- To generate an FDA-compliant pdf export for submission and archival purpose
- To provide a scalable, cost-effective solution in anticipation of future needs
ETHICAL’S SOLUTION
- Ethical’s staff provided guidance for setting up an efficient, compliant process
- Ethical’s eAdjudication® platform was used to collect source documents from sites and manage queries. Hospital staff were guided through a checklist to upload the necessary documents
- An FDA-compliant PDF package for the submission to authorities and archival of the study data was generated from eAdjudication®
- Ethical delivered a scalable, multi-study platform allowing to leverage economies of scale
CLIENT FEEDBACK
“eAdjudication® proved to be the perfect solution for our endpoint adjudication needs. In addition to the tool’s remarkable capabilities, we received exceptional support from the Ethical team who guided us seamlessly through every phase of the process, providing a comprehensive, efficient and compliant clinical endpoint adjudication solution.”
eADJUDICATION®: COMPLIANT AND COST-EFFECTIVE ENDPOINT ADJUDICATION COMMITTEES MANAGEMENT
eAdjudication® offers such flexibility that the software configuration and support provision are tailored to exactly match your need.
