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International Clinical Trials

Compelling Advantages of Creating a Patient-Centric Supply Chain


In 2020, the prospect of shipping perishable COVID-19 vaccines around the globe pushed the pharmaceutical cold chain into the spotlight. The requirement for trustworthy, climatecontrolled transportation and storage at an unprecedented scale and reach called attention to the complexities surrounding the worldwide distribution of temperature-sensitive medicines and clinical trial materials (CTMs).

At the same time, investigations in modalities such as cell and gene therapies continue to proliferate, with related complex supply chain needs. As personalised medicines and other types of clinical trials have grown more global and patient-centric, the industry demand for fast-turnaround and/or direct-to-patient (DTP) and direct-from-patient (DFP) capabilities has increased sharply. The capacity and expertise to manage a multitude of complicated variables from the expiration of sensitive medicines, to special handling requirements in transit, to global regulatory considerations is crucial to support a broad demographic of global patients as they participate in a wide range of clinical trials from home.

Patient wellbeing and clinical trial success both hinge on efficient, compliant CTM distribution and administration. When combined with robust infrastructure, global experience, and innovative packaging solutions, the storage of supplies and clinical drug products close to patients, when appropriate, can be a key strategy. Only a clinical trial supply chain partner that offers expert global regulatory and trade compliance proficiency and that transports shipments in a secure, closed-loop environment while meeting all GDP/GMP/GCP standards can successfully address the complex demands of the patient-centric supply chain Ė and enable sponsors and CROs to keep clinical trials moving forward with on-time delivery of lifesaving treatments.

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Nina Vas is Markenís Vice President, Clinical Distribution, Cell & Gene Supply Chain and leads Markenís global GMP depot network as well as its fast-growing cell and gene division. She brings financial, operational, quality, and practical process improvement experience managing the performance of the full supply chain which supported the execution of distribution for clinical trials to global destinations. Nina's background includes importing of drug product (from API to finished goods and ancillaries) with clinical research organisations, pharmaceutical importers, owned facilities, and third‐party depots.
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