Korean Health Authorities Grant Permission during Emergency Situation Marken, the leading clinical trial logistics organization providing solutions and services to the life sciences industry, has been granted permission by the government to deliver the first direct to patient shipment of clinical drug product in Korea. This precedent-setting shipment has allowed several patients in South Korea to continue receiving their clinical trial drugs during the outbreak of Middle East Respiratory System (MERS).The emergency was caused by recent partial closures of medical centers due to fears of spreading MERS. Patients were therefore unable to travel to the centers to receive their clinical drug. Recognizing this, the Ministry of Food and Drug Safety in Korea (MFDS) agreed to temporarily allow direct shipments to patients’ homes so the trials would not be compromised.
Pharmaceutical Companies and contract research organizations (CROs) which are running clinical trials can make requests to the MFDS, thus allowing direct to patient home deliveries. Marken has done several such shipments to homes in Seoul, Gyeonggi, Boryung in Chungchengnamdo, Gochang in Jeollabukdo, and Yeosu in Jeollanamdo. The shipments were delivered safely and within the time and temperature range specified by the drug manufacturer. These are the first such shipments to be allowed in Korea. Linda Kim, General Manager of Marken Korea, said, “Marken is proud to provide a solution which helps patients continue their trial medicine during this crisis. We have been able to quickly respond to the need and have met all of the government safety protocols for delivering drugs.”
Marken is a leader in direct to patient shipments for the pharmaceutical industry. The company has sponsored numerous workshops and technical sessions around the world, explaining how these home shipments can be handled without compromising a clinical trial protocol. The most recent presentation was given at the Drug Information Association (DIA) Annual Meeting in Washington, D.C (US). Patient recruitment and retention are two of the biggest challenges in clinical trials. Bringing the trial to the patient’s home increases willingness to participate and may provide better patient retention and compliance. Patients who face travel restrictions or those who suffer from illnesses which prevent travel may find it easier to participate and remain enrolled in a clinical trial.
Leslie Chaney, Marken’s Global Director for Preclinical and Direct to Patient Services said, “Marken will continue to grow, adapt, and evolve our Direct to Patient services for the industry. Our client feedback indicates that the patient-centric focus is on a fast pace of growth. We are honored that the DIA gave us the opportunity to share our experience with their membership.”
About Marken
Marken is the leading global clinical supply chain solutions provider dedicated to the pharmaceutical and life sciences industries, supporting over 49,000 clinical investigators in more than 150 countries. Marken integrates depot and logistics into solutions that extend the reach of clinical trials to even the most remote treatment-naive geographies. Marken is 100% dedicated to the clinical research industry and a specialist in the transportation of investigational medical products and medical devices. In addition to services such as the storage and distribution of clinical trial materials and drug products to investigators or the patients directly, Marken maintains a leading position for the shipment of biological samples and offers additional services such as shipment lane qualifications as well as GDP, regulatory and compliance consultancy.
