As clinical trials move more and more into the community, the planning and delivery of a patient centric approach is becoming more important than ever. As the industry moves towards these models, how can we ensure that the trials still meet with regulatory requirements, both from a GxP, GCP and a country specific MOH/DOH perspective?
Understanding the local legislation surrounding home healthcare provision is a key component to planning your trial, for instance, can homecare nurses administer your product unsupervised in a patient’s home? Equally, understanding local pharmacy, importation and distribution regulations has to be factored into your country selection and timeline planning.
In this webinar, World Courier and Medical Research Network will guide you through the key regulatory considerations when planning direct to patient trials, as well as providing practical examples to ensure that the quality of your trial delivery is maintained.