Ethical GmbH
12 Case Studies
A Ethical GmbH Case Study
Multinational Sponsor Company, a US-based sponsor running a Phase III COVID-19 vaccine study across North America, South America, Africa, and Europe, needed an endpoint adjudication platform deployed urgently during the public health crisis. The challenge was to support a rolling team of 5–6 adjudicators handling high volumes of cases, with experts spread across three time zones and limited availability. Ethical GmbH provided its eAdjudication solution to meet this need.
Ethical GmbH delivered a working adjudication platform within two weeks, configured to the study charter and validated under Good Clinical Practice and GAMP5 guidelines. Ethical also automated case and event-document imports, enabled automated submissions to match adjudicator availability, implemented enhanced data quality checks, and managed disagreements remotely. The sponsor reported that Ethical was innovative and flexible, and the solution supported submission of up to 120 cases per week.
Multinational Sponsor Company