The future of clinical trials: How to ensure compliance in a decentralized model

The impact of the COVID-19 pandemic continues to resonate in every sector. Biopharma is no exception. Supply chains have been strained to breaking point. Clinical trials have been suspended or reconfigured. The assumptions underpinning distribution models have been overturned.

Under considerable pressure to sustain some sort of ‘business as usual’ – and mitigate the impact on patients’ lives – the industry had to find alternative ways of working, such as utilizing new routes and adjusting study protocols, including a rise in demand for direct-to-patient delivery for clinical trials.

As part of our response to this unique situation, World Courier undertook research to better understand customers’ perceptions of the impact of the pandemic. Chief among our findings was a major shift to decentralized trials, and a possible permanent move away from just-in-time distribution.

During this presentation, World Courier’s Kelly Frend, Personalized Supply Chain Manager, and Arnold Bernard, Senior Manager, Specialty Group, will explore the direct-to-patient delivery model for clinical trials as well as new decentralization dispense models and the impact on how drugs and treatments are administered. They will assess the importance of examining the potential implications of a decentralized model, emphasizing compliance requirements and data protection.

Kelly Frend

Personalized Supply Chain Manager

World Courier

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Kelly is Personalized Supply Chain Manager at World Courier. Kelly has more than 17 years of experience within the specialty transport and logistics industry. At World Courier, Kelly is a subject matter expert in temperature-controlled logistics, with a deep knowledge of Direct-to-Patient and Cell and Gene Therapy supply chains. She is responsible for leading the European region by overseeing all specialty service offerings within this area. She maintains a thorough understanding of the regulatory landscape and drives improvement initiatives that ensure all customers receive the highest level of service at all times.

Arnold Bernard

Senior Manager, Specialty Group

World Courier

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Arnold Bernard is a Senior Leader within World Courier’s Customer Service Organization. With over 23 years of experience in various management roles, Arnold has led with a customer focused approach that has benefited many facets of the organization from Customer Service to Vendor Management, Compliance, and IT development. Under his leadership, Arnold’s Specialty Group brings industry leading innovation to such areas as active and passive pharmaceutical logistics and clinical trials execution. Most recently, Arnold has led World Couriers efforts to develop logistics planning for what World Courier has branded as Personalized Solutions to include Direct to Patient and Cell and Gene Therapy service offerings. These have been identified as key growth areas in drug delivery that require a highly detailed level of planning and execution. Arnold has always led a client centric approach that identifies challenges in what can be complex business models, while providing solutions that directly benefit the patient.