Case In Point
Overcoming Enrollment Challenges in a Global Phase III Trial for Acute Cardiovascular Emergencies
About Client
A clinical-stage biotechnology company, developing an investigational therapy for the emergency treatment of ST-elevation myocardial infarction (STEMI), faced significant enrollment challenges during its Phase II clinical trial.
Everest Clinical Research was engaged to help rescue enrollment by rapidly activating high-performing sites in Central Europe. This positioned Everest as a key operational partner as the program advanced into a pivotal global Phase III trial. Everest subsequently expanded its support across North America and Europe, providing scalable clinical operations that enabled the study to meet its ambitious enrollment goals.
Challenge
The rapid expansion from a Phase II study to a large global Phase III trial substantially increased enrollment targets and the need for scalable clinical operations.
The therapy needed to be administered within minutes of STEMI diagnosis, at the earliest point of medical contact by emergency first responders or emergency department staff, presenting significant operational, regulatory and logistical challenges.
Successful enrollment depended on seamless coordination among emergency medical services, hospitals, investigators, ethics committees, and regulatory authorities while maintaining protocol compliance during life-threatening medical emergencies.
Compounding this complexity, each participating country had unique regulatory and ethics requirements governing informed consent in emergency research.
Solution
Everest partnered closely with the sponsor to develop and implement operational strategies that enabled rapid patient enrollment while ensuring compliance with country-specific regulatory requirements.
To support efficient enrollment, Everest activated sites within integrated ambulance-hospital systems whenever possible, allowing emergency responders and hospital investigators to work as a unified team. Where integrated emergency systems were not available, Everest established emergency department-based enrollment pathways that maintained protocol compliance while eliminating the need for ambulance coordination.
Everest operationalized country-specific informed consent procedures to align with local regulations, including emergency exception pathways, abbreviated consent processes during acute care, and verbal consent models where permitted.
Beyond patient enrollment, Everest provided comprehensive clinical operations support, including site activation, monitoring, Trial Master File remediation and maintenance, emergency unblinding through its in-house Interactive Response Technology (IRT) system, and flexible resourcing that enabled the sponsor to scale efficiently while controlling costs.
Results
Everest successfully expanded from a regional engagement to become a major operational partner in a pivotal global Phase III cardiovascular study spanning multiple countries.
Key outcomes included:
- Supported approximately 50% of total patient enrollment in the global study.
- Contributed to the successful enrollment of more than 2,400 patients across 45 international sites.
- Successfully implemented compliant emergency enrollment and informed consent procedures across multiple regulatory jurisdictions.
- Enabled uninterrupted study progression through scalable clinical operations, site management, and regulatory support.
- Maintained regulatory readiness through comprehensive Trial Master File management and operational oversight.
