A Rapid Move to Direct-to-Patient Clinical Trial Across Five Continents in the Midst of COVID-19
Case Study DIRECT-TO-PATIENT
When governments around the world issued stay-at-home orders in response to COVID-19, not only did borders shut down – public transportation in many cities did as well. As a result, some of a large pharmaceutical’s patients were having difficulty getting to their trial sites, which were located in dozens of countries across five continents. To avoid jeopardizing their various studies, the company wanted to convert its traditional clinical trials to a direct-to-patient (DTP) model wherever possible. This was challenging, however, since there were several trials for different types of therapies – each of which had to be transported at a different temperature. The conversion also had to happen quickly so patients did not miss any doses.
Working closely with the study sponsor, QuickSTAT helped set up a DTP model across all therapies, geographies and temperature profiles according to local regulatory requirements. This involved leveraging QuickOnline, QuickSTAT’s cloud-based system, for:
- Enhanced control over the entire supply chain, allowing for speed to scale with secure access unique to each user
- Customized QuickOnline RX user preferences, which were set up based on trials supported by client stakeholders managing the supply chain
- QuickOnline user preferences included temperature monitoring requirements, automatic milestone alerts to stakeholders, and high- level reporting by protocol, program, region or other preferred segmentation.
- Adhering to HIPAA laws, ensuring patient privacy was maintained for each trial
- Meeting TSA Known Shipper requirements via written designation
- Zero missed doses were reported across trials for patients opting in to the new DTP model
- Based on the success, the company is now in the process of planning for DTP capability as a default for any new trials that are suitable for at-home treatment