Navigating European requirements for clinical trials, clinical investigations and performance studies can be complex and resource-intensive.
Through Sponsorship as a Service, GCP-Service can act as the official legal sponsor of your project and manage the applicable sponsor responsibilities within our established Quality Management System.
You retain scientific leadership and protect your innovation, while we provide the regulatory governance, oversight and infrastructure required to conduct the project compliantly.
Navigating European requirements for clinical trials, clinical investigations and performance studies can be complex and resource-intensive.
Through Sponsorship as a Service, GCP-Service can act as the official legal sponsor of your project and manage the applicable sponsor responsibilities within our established Quality Management System.
You retain scientific leadership and protect your innovation, while we provide the regulatory governance, oversight and infrastructure required to conduct the project compliantly.
A funder provides financing. A sponsor carries ultimate legal and operational liability for:
Establishing safety-reporting processes, evaluating reportable events and fulfilling applicable regulatory reporting obligations.
Submissions to Competent Authorities and Ethics Committees.
Site monitoring, protocol adherence, and audit readiness.
Setting up an in-house QMS to cover these duties can delay trial launch by 12 to 18 months. And an inspection risk often persists well into the study, endangering clinical development. SpaaS gives you access to an established, inspection-ready sponsor framework that can significantly reduce setup time.
| GCP-Service Assumes (Legal Sponsor) | You Retain (Innovator) |
|---|---|
|
Regulatory & Ethics Filings |
100% IP & Patent Ownership |
|
Safety Oversight & Monitoring |
Scientific Leadership & Protocol Design |
| GCP-Service Assumes (Legal Sponsor) | You Retain (Innovator) |
|---|---|
|
Regulatory & Ethics Filings |
100% IP & Patent Ownership |
|
Safety Oversight & Monitoring |
Scientific Leadership & Protocol Design |
Bypass institutional legal bottlenecks and focus on clinical research.
Execute early-phase trials without building expensive in-house quality assurance structures for clinical development.
Bypass institutional legal bottlenecks and focus on clinical research.
Execute early-phase trials without building expensive in-house quality assurance structures for clinical development.
If you answer “No” to any of these questions, SpaaS is your ideal path forward
“True support in clinical research goes beyond funding. Taking on sponsorship responsibilities means driving a study forward with accountability, expertise, and commitment.”
“True support in clinical research goes beyond funding. Taking on sponsorship responsibilities means driving a study forward with accountability, expertise, and commitment.”
Talk to our experts about your study’s needs and discover how we can help you navigate sponsorship responsibilities with confidence.
Clinical research requires a coordinated approach across multiple disciplines. Explore our complementary services to support your project at every stage.
