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International Clinical Trials

The Rise of Direct-to-Patient




The healthcare industry has changed its focus. The needs of the patient, rather than the needs of the industry, are now at the centre of clinical studies conducted. This patient-centric approach benefits the patient and, ultimately, the success and efficiency of clinical trials.

Conducting a trial can be complicated. With patients geographically spread out, in need of frequent doses, and a drug product that has strict storage and delivery conditions, the process is even more difficult. When dealing with homebound patients, an orphan indication, or a dispersed patient population, patient enrolment and retention can be a challenge.

Specialised clinical supply managers can help a sponsor execute a directto- patient programme to overcome fundamental challenges that prevent the sponsor from conducting a trial. The programme, which provides a highly customisable solution per patient and per protocol, helps reduce the number of patient dropouts and the overall cost of a study.

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About the author


Brian Swites has over 30 years’ experience in the biopharmaceutical industry, specialising in global clinical supply chain management. As Senior Vice President of Clinical Services at Clinigen Group, Brian oversees global capabilities, strategic partnerships, and ensures overall growth and performance goals are being met. Prior to joining CSM, which later became part of Clinigen Group, Brian held various management positions during his 13 years at Cephalon/Teva Pharmaceuticals Industries. He received his Master’s Degree in Pharmaceutical Manufacturing from the Stevens Institute of Technology, US.
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