Critical Need for Patients to Receive Treatment at Home Spurs Sponsor Requests
RESEARCH TRIANGLE PARK, North Carolina, April 9, 2020 /PRNewswire/ -- The prevalence of shelter-in-place restrictions and reduced hospital capacity due to the Coronavirus pandemic has resulted in the first global disruption to traditional onsite clinical trials. Direct to/from Patient (DTP/DFP) and Home Healthcare (HHC) services provide solutions to keep clinical trials going, while maintaining patient safety, by shipping treatments directly to participant's homes. Through DFP services, biological samples can be retrieved from a patient's home and sent to laboratories for testing. Combining DTP services with home healthcare services allows patients to respect the confinement guidelines of their location while continuing to participate in their clinical trial.
As of March 30, nearly 30 biotech or pharma companies1 have reported a disruption to a clinical trial as a result of the crisis. The U.S Food and Drug Administration, the National Institutes of Health, the European Medicines Agency, China's National Medical Products Administration and several other entities have issued guidelines pertaining to the conduct of trials during the pandemic and are in full support of virtual services.
After sponsors secured permission to include DTP services into their protocols, Marken successfully coordinated logistics and delivery of thousands of clinical drug products directly to patients participating in trials throughout Asia, Europe, the US and Latin America. All Marken staff and selected partners are trained to provide DTP services after the personnel perform careful risk assessments to ensure time and temperature control will be maintained for each shipment.
Ariette van Strien, President of Marken, commented, "The move towards Direct to Patient services in so many trials across the globe is unprecedented. Working closely with our clients, we have onboarded DTP trials in as little as a few days, as opposed to a more typical timeline of several weeks. Our teams have worked together to quickly procure and coordinate the temperature-controlled packaging solutions and temperature monitors into all countries. We have adapted our Standard Operating Procedures (SOPs) and processes to accelerate the onboarding of new clients and trials due to the high demand to deliver treatments to thousands of patients in need. We are honored to be the chosen supply chain provider for our clients as we navigate, together, through this difficult crisis."
1 A guide to clinical trials disrupted by the coronavirus pandemic
About Marken
Marken is a wholly owned subsidiary of the UPS Healthcare division. With Polar Speed and Marken included, the UPS division staffs 128 locations with 5000 employees worldwide. Marken maintains the leading position for Direct to Patient and Home Health care services, biological sample shipments and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 54 locations worldwide for clinical trial product storage and distribution. Marken's dedicated 1200 staff members manage 90,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries. Additional services such as biological kit production, ancillary material sourcing, storage and distribution, shipment lane verification and qualifications, as well as GDP, regulatory and compliance consultancy add to Marken's unique position in the pharma and logistics industry.
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