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Emergency shift to Direct-to-Patient clinical trials to protect immunocompromised patients during COVID-19 | Clinical trial and cold chain logistics

The company helped a client shift to a direct-to-patient model for their clinical trials during COVID-19.
The client needed to do this to ensure that immunocompromised patients could continue to receive their medication.
The company was able to help the client set up a system that allowed them to ship medication directly to patients’ homes.

A Contract Research Organization (CRO) needed to convert its clinical trials to a Direct-to-Patient model to ensure an uninterrupted drug supply for immunocompromised patients.

CHALLENGE

One of a CRO’s clients was conducting a clinical trial treating severely immunocompromised patients. Many of these patients were unable to get to trial sites for various reasons due to COVID-19 – whether sites were unavailable, public transportation had been shut down or patients simply didn’t want to make an in-person visit given their high-risk status. The trial was taking place in several countries impacted by the lockdown, including Poland where borders were closed at the time. Patient shipments had to be transported at 15-25ºC, and then temperatures validated prior to dosing to ensure therapies had stayed within the appropriate range. Given the pandemic, shipments also needed to be collected from local sites and delivered to patient homes using contactless methods.

SOLUTION

QuickSTAT worked closely with the CRO to train over 250 sites in three days to utilize QuickOnlineRX, QuickSTAT’s online system for customers to facilitate compliant Direct-To-Patient (DTP) bookings. This helped to set up a DTP model that:

  • Leveraged QuickOnlineRX, QuickSTAT’s cloud-based system for complete control over the entire supply chain, allowing for speed to scale with secure access unique to each user
  • Registered and trained all 250 sites on using QuickOnline 2.0 for DTP bookings in just three days, using video, user guides and live training sessions
  • Enabled the shipment of hundreds of 15-25ºC temperature-controlled packages to various countries throughout the world, regardless of whether borders were open
  • Successfully met HIPAA requirements to ensure patient privacy was maintained from pickup through delivery
  • Developed and implemented standard operating procedures for contactless collection from sites and delivery to patients
  • Temperature was monitored in transit and confirmed via temp loggers that it was maintained according to client specifications, prior to dosing of patients

OUTCOMES 

  • Implemented a DTP model from beginning to end within seven days
  • Supported the initial shipment of more than 250 packages with no excursions outside the required temperature range or the agreed-upon 30-minute delivery window