Case Study: Actelion Pharmaceuticals Ltd achieves faster, higher-quality endpoint adjudication and timely study completion with Ethical GmbH's eAdjudication®

Actelion Pharmaceuticals Ltd - Customer Case Study

Actelion Pharmaceuticals Ltd faced the challenge of centrally adjudicating complex, partially subjective clinical endpoints for its large global Phase III SERAPHIN trial of macitentan (Opsumit). To manage blinded, trackable assessments by external expert clinicians across 151 sites and reduce expert burden and endpoint cycle times, Actelion engaged Ethical GmbH and its cloud-based Ethical eAdjudication® portal.

Ethical GmbH implemented the Ethical eAdjudication® system — a centralized repository with real-time submissions, role-based workflows, online assessment forms and notifications — to streamline package delivery and expert review. The vendor’s solution significantly reduced Sponsor time and costs for event delivery and tracking, minimized experts’ time and training, enforced process compliance, and supported adjudication of 287 events in the SERAPHIN study (742 patients enrolled), helping enable timely study completion and subsequent regulatory approvals including FDA approval of Opsumit (macitentan).

Actelion Pharmaceuticals Ltd

Loïc Perchenet

Director, Global Post-Approval Studies Global Medical Affairs