Switching To Direct-To-Patient Rapidly In The EU
Source: PCI Pharma Services
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
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