Travel Restrictions and Supply of Clinical Drug Product Created Critical Situation for Patient
Unable to return home to the U.S. with limited travel options due to COVID-19, an immunocompromised patient required help obtaining the clinical drug needed for treatment while temporarily living in South Africa. Marken helped clear the complex regulatory hurdles and delivered their required medication to keep the patient enrolled in the trial.
To deliver clinical study medication from a U.S. investigator site to a patient in a country where the drug is not available, within a short time frame before the patient's supply ran out.
The importation of clinical drugs can present complex regulatory hurdles to overcome for Customs clearance into South Africa. The U.S. Embassy and South African Health Products Regulatory Authority (SAPRHA) offices were both closed due to COVID-19. Marken engaged the U.S. Department of State in Washington, D.C. for their assistance to intervene and obtain the required SAPHRA entry approval on the patient's behalf.
A cross-functional Marken team worked together to outline and coordinate the many regulatory documents and compliance clearance forms needed by SAPRHA. Following several unsuccessful attempts to reach the responsible authorities at SAPRHA, Marken reached out to the U.S. Department of State as well as the U.S. Embassy in South Africa for intervention and assistance. A designated Marken team member maintained one point of constant communication with the trial sponsor, pharmaceutical company, the U.S. investigator site, and all the internal Marken teams to keep everyone apprised of the process and developments, while maintaining full compliance with all privacy laws. The patient communicated directly with the investigator site for updates.
The patient received their clinical drug supply for the duration of their stay in South Africa, avoiding any disruptions to their trial enrollment and status, or their treatment.
About Marken
Marken is the clinical precision logistics and advanced therapy subsidiary of UPS Healthcare. The UPS Healthcare network consists of 200+ locations worldwide.
Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution in 46 locations worldwide, while maintaining the leading position for cell and gene therapy services, direct-to-patient and home healthcare services, biological sample shipments and biological kit production. Marken’s dedicated 2,600+ staff members manage 200,000 drug product and biological sample shipments every month at all temperature ranges in more than 220 countries and territories and have orchestrated 17,500+ home healthcare visits. Additional services such as 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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