Key Highlights
Providing Clinical Operations Leadership Across Europe and the US
Clarenta supported a European immuno-oncology biotechnology company in the design and delivery of a first-in-human Phase I/IIa clinical trial conducted across Europe and the United States.
Working as an extension of the Sponsor’s team, we provided clinical operations leadership, European trial execution and oversight of the US CRO while meeting demanding operational milestones.
The Challenge:
The Sponsor needed to evaluate its lead immuno-oncology candidate as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced relapsed or refractory cancers.
The trial presented several strategic and operational challenges:
- It was the Sponsor’s first-in-human clinical trial
- Study activities were conducted simultaneously in Europe and the United States
- The Sponsor required an experienced partner to assume responsibility for its clinical operations function
- Patient recruitment and US monitoring had been subcontracted to a large CRO requiring Sponsor-level oversight
- Multiple specialist vendors needed to be coordinated across regions
- Operational milestones were linked to the Sponsor’s financing strategy
- Trial delivery required close alignment among the Sponsor, European sites, vendors and the US CRO
Our Solution:
We implemented an embedded clinical operations model and operated as an integrated part of the Sponsor’s organisation.
Our team:
- Provided interim Head of Clinical Operations leadership
- Supported the design and execution of the first-in-human basket trial
- Managed clinical trial application submissions in Europe
- Led European clinical project management
- Managed European clinical monitoring activities
- Coordinated European investigator sites
- Managed specialist clinical trial vendors
- Oversaw recruitment and patient-retention activities
- Trained the clinical operations team on the protocol, investigational product and mechanism of action
- Oversaw the US CRO responsible for monitoring, data management, statistics, the central laboratory and pharmacovigilance
- Maintained close communication among the Sponsor, sites, vendors and CRO
Monitored progress against operational and financing-linked milestones
The Outcome:
We completed the EU regulatory submission within two weeks of the final protocol and supported the enrolment of the first European patient on schedule.
A total of 262 patients were recruited across Europe. The agreed clinical operations objectives and milestones were delivered within the required timelines.
The successful delivery of the first-in-human trial led the Sponsor to award our team a second clinical study.