Joining the fight against COVID-19
Clinical trial COVID-19 regulatory submissions
Who we are
ÅKRN is a European Medical Device and In-Vitro Diagnostics CRO that can accelerate to get clinical trial approval for key medical devices such as:
- COVID-19 Diagnostic tests | Rapid test | Serological test
- Hyperbaric Oxygen Therapy (HBOT) | Hydrogen-Oxygen Generator | Bidirectional Oxygenation Valve | CPAP machines
- Patient Monitoring condition software | Telerehabilitation platforms | Telemedicine platforms
- Biosensors | Medical Masks | Blood filters
To accelerate innovation and approval of treatments that aid in this global emergency to battle the pandemic, we put our CRO team at AKRN at service in the fight against COVID-19. We can support you to perform COVID-19 related regulatory submissions to the European Competent Authorities and Ethics Committees.
Free of charge
To ensure we support academic investigators and small and mid-sized companies to get medical devices and diagnostic products on the market as soon as possible, we have decided to perform our services free of charge*.
COVID-19 Regulatory Submission Services
- Clinical Investigation Protocol (CIP) Review
- Informed Consent Form (ICF) Review
- Clinical Trial Application Support
- Essential Clinical Site Start-up Activities
Contact us for more information
*Proposal valid until 30 June 2020. Please contact us for more details on the specific services provided.