Phase II study in Infectious Diseases (2019). Multinational sponsor company needs a user-friendly adjudication platform able to support access for 110 sites and integrate with several vendors’ systems.
CLIENT
Sponsor (Multinational, EU-based)
DISEASE AREA
Infectious diseases
STUDY INFORMATION
Phase II
Executed in North America, South America, Asia and Europe
25 countries – 110 sites – 375 participants
YEAR INITIATED
2019
REQUIREMENTS
- To design an adjudication package composed of variable data, source documents from sites, images from a central system and eCOA data
- To integrate eAdjudication® with the sponsor EDC, the imaging vendor platform and eCOA vendor system
- To collect source documents directly from sites
- To translate source documents when they are not available in English from the sites
ETHICAL’S SOLUTION
- Ethical coordinated the integrations with the other vendors’ systems
- eAdjudication® interfaces were optimized to show the data to adjudicators in a pleasant way. The eCOA questionnaire was also displayed in a friendly way
- The adjudicators easily accessed the imaging vendor platform by clicking on a link with embedded authentication
- Source documents were collected from sites directly into eAdjudication®, the hospital staff were guided through a checklist to upload the needed document. Likewise, queries were managed through eAdjudication®.
- An integration was available for the translator partner to upload the translated documents.
CUSTOMER FEEDBACK
“Thank-you Ethical for all your hard work on the trial, the result is a great tool. I appreciated your training for the committee members, the demo was very engaging and provided an excellent kick-off for the adjudication committee.”
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.
