COVID-19 public health crisis (2020). Emergency request from a multinational sponsor company. Within two weeks, Ethical delivers a working adjudication platform, trains users, and starts submitting up to 120 cases per week.
CLIENT
Sponsor (multinational, US-based)
DISEASE AREA
Infectious diseases (vaccine)
YEAR INITIATED
2020
STUDY INFORMATION
Phase III
Executed in North America, South America, Africa and Europe
100 countries – 250 sites – 44,325 subjects
REQUIREMENTS
- To deliver ASAP an adjudication platform to support the development of a vaccine against COVID-19
- To be able to submit up to 120 cases in a week to a “rolling” team of 5-6 adjudicators with varying availabilities
- To support the resolution of disagreements in a context where experts located in three distinct time zones are under pressure
ETHICAL’S SOLUTION
- Within two weeks from sponsor request, Ethical delivered a working solution configured according to the study charter and validated following Good clinical practices and GAMP5 guidelines, and was able to train all the experts
- Due to the high volume of data, the import of the cases, including event documentation, was automated
- Events submission was also automated, allowing to adjust to adjudicators’ availability
- An enhanced data quality process helped verify the coherence of the information and documents loaded into the platform
- Data requests were handled daily by the Ethical coordinator in close liaison with the sponsor team
- An innovative “remote” disagreement management process was tested with the experts and adopted by the sponsor
CLIENT FEEDBACK
“I find Ethical very innovative and flexible. They have found solutions to all our requests, and they constantly adapted to different volumes of events, even with short notice.”
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.
