Horizon Europe has opened its gates to Clinical Trials. Clinical Trials are funded in Horizon Europe via the Research and Innovation Actions (RIA), addressing various areas such regenerative medicine, advanced therapies, rare diseases and more. However, the typical Clinical Trial structure (mostly Industry-Sponsored) does not naturally comply with the RIA structure and funding scheme. This means that establishing and planning a Clinical Trial-focused RIA is a challenge.

 

 

There are several inherent discrepancies:

  • Differences between the Horizon Euope funding cycles and payment structure of Industry-Sponsored Clinical Trials
  • Fixed Conseortium 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 was involved in various Clinical Trials projects since 2008 (FP7) and throughout the most recent Horizon 2020 programme.

 

On top of our regular Pre-award services, we provide the following services to Clinical Trial project under Horizon Europe:

  • ‘Unit Cost’ based projects vs. ‘standard’ RIA projects: We have the unique experience in handling the challenge of mitigating between the Horizon Europe RIA structure and the various Clinical Trials structures, and presenting the project in the best possible way, while addressing the special needs of the Clinical Trials.
  • Exploiting the sub-contracting privileges in Horizon Europe Clinical Trials.
  • Structuring the ‘Essential information for clinical trials’ annex, based on the above and 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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