Switching To Direct-To-Patient Rapidly In The EU

By Gavin Morgan, Senior Manager, Global Logistics - Clinical Services, PCI Pharma Services

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