Earlier this week Laura Van Vaeck gave a keynote talk the COG CRO Europe event in Amsterdam.  

 Laura’s talk on ‘Navigating the complexities of drug-device combination studies and the impact of the EU IVDR‘ highlighted the regulatory differences between device and pharmaceutical trials during study study start-up of combined studies, explored how device specific regulatory expertise and EU IVDR compliance considerations impact study start-up timelines and complexity. She later answered questions from the audience.  

With the right CRO, you can hit crucial regulatory milestones with confidence; giving the technology you’ve spent years building its best chance to reach clinicians and patients.  

Your device has the power to change lives. Let’s make sure it gets the chance to. https://franklynhealth.com/contact-us/