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 approval for this deviation from the original clinical protocol.

  • 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 

Download the “Switching to Direct-to-Patient Rapidly in the EU” White Paper (pdf)

We provide a complete range of clinical trial supply services and we are committed to supporting clients at every stage of the clinical cycle, delivering best-in-class services efficiently and effectively.

Find out more about our Clinical Trial Services here

Our dedicated team of specialists will be happy to discuss any of your Pharmaceutical Development needs. Contact us on +1 779-208-1819 (US) or +44 1495 711 222 (UK/EU) or email talkfuture@pci.com