Phase III cardiology study (2021). Medium sized, EU-based CRO engaged in a process optimization and standardization effort, needs ASAP an adjudication platform able to integrate with its system as well as with the sponsors’.
CLIENT
CRO (Medium sized, EU-based)
DISEASE AREA
Cardiology
YEAR INITIATED
2021
STUDY INFORMATION
Phase III
Executed in Europe
2 countries – 100 sites – 6,400 subjects
REQUIREMENTS
- To deliver ASAP an adjudication platform that could integrate with the CRO and sponsor systems and match the sponsor’s budget constraints
- To provide audit trail for source documents and generate FDA-compliant PDF exports
- To support process optimization and standardization initiated by the CRO
ETHICAL’S SOLUTION
- 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 document. The training video is available 24/7 through the platform
- eAdjudication® was integrated with the CRF in use by the CRO and the systems in use by the sponsor to collect data and upload data export, creating an automated flow to reduce human error and speed up the process
- An FDA-compliant PDF package for the submission to authorities and archival of the study data was generated from eAdjudication®
- Ethical set up the study in a few weeks so that the sponsor could start creating events and collect event data ASAP
CLIENT FEEDBACK
“With the eAdjudication® endpoint adjudication process, documentation and information are managed 100% by the web-based system without any paperwork. The CEC members can log in to eAdjudication® at any time and at any place. The platform is very efficient, and we have a great overview of the events status, submission, and adjudication.”
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.
