Direct-To-Patient Solutions for a Rare
Disease Clinical Study

CHALLENGE

A biotech company conducting a global Phase III study for a rare disease was facing enrollment difficulties, and was looking for solutions to minimize dropout rates among their enrolled patients who were either too sick or immobilized to physically go to a doctors office or lab. In order to ensure high enrollment and retention, the company turned to QuickSTAT to provide Direct-to-Patient Services, which included home delivery of the drug to the patient, and pick up of patient samples from their home to the central lab for testing.

The shipments had to be transported at 2-8°c to maintain the integrity of the drug product. In addition, the biotech company had to make sure that the process complied with the HIPAA laws protecting the patient's information.

SOLUTION

Temperature-controlled Direct-To-Patient service supported by a technology solution that ensured patient privacy.

• QuickSTAT reviewed the protocol of the study and designed a customized supply chain plan for the client.
• In the countries participating in the trial where Direct-to-Patient home delivery services are allowed, QuickSTAT created a logistics solution that allowed for the drug to be delivered at 2-8°c and received by the home health care nurse at the exact time of their visit to ensure the drug integrity was maintained in transit and was available to the nurse at the scheduled time of dosing.
• QuickSTAT also arranged to collect the patient's sample from the home health nurse at the end of the visit, providing the dry ice and UN3373 packaging needed to transport these clinical samples to a central lab for testing.
• In addition, QuickSTAT was able to abide by HIPAA laws and maintain all of the clinical trial patient's privacy by leveraging our proprietary IT systems, QuickTRAC and QuickOnlineRX to ensure the privacy of all patient information.