Contract Pharma Staff04.13.20
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. According to Marken, 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 companies have reported a disruption to a clinical trial as a result of the crisis. The U.S Food and Drug Administration (FDA), the National Institutes of Health (NIH), the European Medicines Agency (EMA), 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 has coordinated logistics and delivery of thousands of clinical drug products directly to patients participating in trials throughout Asia, Europe, the U.S. 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.
"The move towards Direct to Patient services in so many trials across the globe is unprecedented,” said Ariette van Strien, president, Marken. “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.”
As of March 30, nearly 30 biotech or pharma companies have reported a disruption to a clinical trial as a result of the crisis. The U.S Food and Drug Administration (FDA), the National Institutes of Health (NIH), the European Medicines Agency (EMA), 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 has coordinated logistics and delivery of thousands of clinical drug products directly to patients participating in trials throughout Asia, Europe, the U.S. 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.
"The move towards Direct to Patient services in so many trials across the globe is unprecedented,” said Ariette van Strien, president, Marken. “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.”
