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Rüdiger Weber, EU PresidentIf one is to define the true capabilities of CSM clearly, its recent partnership with a clinical drug trial sponsor would be a fitting testament. Before joining hands with CSM, the trial sponsor was striving for operational excellence for an incredibly complicated clinical trial. Patients who participated in the trial needed to adhere strictly to a defined dosage, which required them to administer their doses three times a day, for 14 consecutive days. Besides, the intricacy of the drug required it to be reconstituted no more than 48 hours before dosing to retain its efficacy. Evidently, the trial sponsor needed a smart and accurate clinical supply chain management in addition to detailed monitoring, precise planning, and coordination between all the involved parties. Once CSM was onboarded, they worked alongside the sponsor to prepare new batches of the specific drug for daily shipment along with personalised logistics plans for each patient. Further, CSM devised a custom shipping method for uninterrupted and timely Direct-to-Patient delivery combining flights with on-ground courier services.
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What helps CSM take up such challenging clinical supply chain management projects is its over two decades of experience in the international drug development processes and regulatory norms
The team of experts at CSM works each day to live up to the innovative spirit of the company’s legacy. Although the history of CSM is illustrious in the customised clinical supply and biological sample services arena, it has never stopped the company from innovating, revising, and developing new capabilities. Following its core mission, now as part of the Clinigen Group, CSM is committed to continue offering end-to-end support of any new or modified product through Phase I to Phase IV clinical trials and into commercialisation.
Company
Clinical Supplies Management (CSM)
Management
Rüdiger Weber, EU President
Description
Today, as the success of a trial depends on the service provider’s proven experience in conducting international studies, dealing with global trial complexities, and managing operational, regulatory and coordination challenges, CSM brings over two decades of strong expertise in managing Direct-to-Patient studies, and working with many trial sponsors, couriers, and clinical sites. CSM makes clinical trials more cost-efficient and reliable with specialised services like On-Demand packaging and labelling, Direct-to-Patient shipping, QP services, and biological sample management. One key aspect that truly differentiates CSM from its competitors is its innovative On-Demand services. With CSM’s On-Demand method, its partners are able to shorten trial timelines, reduce clinical trial costs, increase the flexibility of drug discovery study, and tackle any packaging and labelling difficulties