Company insight


Yourway's new Dublin GMP depot boosts biopharma logistics with critical services such as temperature control, clinical packaging, and decentralised trial solutions.


Organisation (WHO), from controlled room temperature to –185°C cryogenic storage. Further, temperature-controlled storage and transport is fully integrated with all aspects of its biopharma services, including clinical packaging and project management.


Clinical trial packaging – Packaging, including primary and secondary as well as labelling, is an important part of clinical trials. Primary packaging can include bottling, encapsulation, over- encapsulation and blistering, and


designed to support all of these packaging needs and more, ensuring therapeutic safety, quality, and integrity. Direct-to-patient services – An industry-wide shift toward trials that take place in a patient’s home, rather than based out of a clinical site, means that logistics must shift as well. When a home nurse is assisting with the trial, a Yourway driver may meet the nurse to transfer an investigational product prior to the home visit. If it is a visit that involves collection of biological samples, a Yourway driver


“Yourway’s new GMP depot expands access to critical services, including temperature control, clinical trial packaging, decentralised and at-home trial solutions and regulatory expertise.”


repackaging of investigational medicine. Secondary packaging may include kit design, which involves study drugs, placebos, comparator drugs, and ancillary materials, and requires design for ease of use, minimisation of space and materials, and maximisation of travel integrity. Yourway’s Dublin depot is custom-


Clinical Trials Insight / www.worldpharmaceuticals.net


may wait with the labelled, temperature- controlled boxes, whether it is one sample to be taken to one lab at one temperature or multiple samples going to multiple labs requiring multiple temperature ranges. The Dublin depot will facilitate these logistics in Europe through coordinated access to necessary materials.


Regulatory support – Clinical trial regulations frequently change, and require a thorough understanding and attention to detail. By providing integrated project management through its Dublin depot, Yourway can facilitate: Qualified Person services for approval of investigational drug or product shipments into the EU; Importer of record services to ensure products are transported throughout the EU in accordance with regulatory requirements; and customs brokerage services for frictionless customs clearance as products cross international borders.


Embracing global clinical trial innovation With many regulatory requirements, global trends, and events that may impact the successful execution of clinical trials, versatile and timely logistical support is central to enabling clinical trials to run smoothly. The opening of Yourway’s GMP depot in Dublin provides exactly that necessary support to the growing clinical trial landscape in Europe. ●


www.yourway.com/dublin-gmp-depot 19


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