Switching to Direct-to-Patient Rapidly in the EU

In response to COVID-19, clinical trial sponsors are looking to site-to-patient transfers as a viable method to deliver medicines to patients and keep their trials on track. In April 2020, the European Medicines Agency (EMA) published guidelines allowing sponsor companies to use site-to-patient transfers as an alternate supply delivery method, without having to get an approval for this deviation from the original clinical protocol. This article will explore the logistical considerations of this including:

  • Maintenance of patient confidentiality in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and General Data Protection Regulation (GDPR) in the United States and Europe respectively
  • Temperature deviation management
  • Execution of contactless deliveries
  • Trans-border / International site-to-patient deliveries 

Learn more by downloading the white paper below.

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