Horizon 2020 and currently Horizon Europe have opened the gate for publicly-funded Clinical Trials. However, the typical Clinical Trial structure (mostly Industry-Sponsored) does not naturally comply with the structure and funding scheme of Horizon Europe. This means that establishing and planning a Clinical Trial-focused project under Horizon Europe may be a challenge.
There are several inherent discrepancies:
- Differences between the Horizon Europe funding cycles and payment structure of Industry-Sponsored Clinical Trials
- Fixed Consortium structure in Horizon Europe vs. dynamic recruitment of patients via medical centers and its associated payment paths
- Typical and strict RIA project duration vs. variable and sometimes flexible Clinical Trials’ time frames
- Ethical and regulatory issues, and conflicts and more
The Enspire Science team has been involved in various Clinical Trials projects since 2008 (FP7) and throughout the most recent Horizon Europe programme.
On top of our regular Pre-award services, we provide the following services to Clinical Trial project under Horizon Europe:
- Structuring the ‘Essential information for clinical trials’ annex, based on the Clinical Trial protocol.
- Clinical Trial Sponsor role and activities definition, including references to legislation, regulation conflicts (US-EU), liability, insurance and other relevant Clinical Trial issues, as needed.
- Selection, negotiation and role definition of the Clinical Research Organisation (CRO), including the definition of the per-patient ‘Unit costs’ payments structure, if relevant.
- Applying for Orphan Drug Designation (ODD) by the European Medicines Agency (EMA), when required.
***It is understood and agreed that provided information must be kept confidential. Enspire Science does not disclose the confidential information obtained.
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