Clinical Trial Logistics: Mitigating Risks Via Advanced Planning for Global Studies

Clinical trial logistical challenges come in many forms: customs issues, stability timelines, temperature control, lost samples, etc. Many of these challenges can be avoided by bringing expertise from your central lab and logistics partners in advance of protocol finalization and the selection of participating countries and sites.

This presentation will discuss potential pitfalls via real life examples and provide the audience with actionable strategies that can mitigate future study execution challenges. Featured speakers will also introduce the audience to important concepts related to importer of record (IOR) and exporter of record (EOR) requirements including roles and responsibilities of sponsors, central labs, CROs and logistics providers.

The speakers will discuss how to consider the intersection of a program’s analytical requirements and logistical realities in advance of final protocol and site selection, with key decisions including:

• Shipper selection
• Transit time analysis
• Coordinating collection schedule with pick-up schedule
• Test shipments — one way or another you will test the lane; do you really want it to be with patient samples?

They will also explore how importer/exporter of record requirements impact decision-making and timing, with key considerations including:

• Customs process is the riskiest part of the transit, where none of the study stakeholders have direct control — site, lab, sponsor, courier, CRO, etc.
• Should be in parallel with study approval in the country, but often occurs long afterward
• Confused ownership leads to lengthy delays

Register for this webinar to avoid the common pitfalls of clinical trial logistics to start a global study off on the right foot.

Speakers

Jeff Mayhew, Chief Development Officer and Co-Founder, LabConnect

One of LabConnect’s founding partners in 2002, Jeff has more than 30 years of operations and business development experience within the health care industry. He also brings to LabConnect more than 20 years of international business experience. Jeff is responsible for the oversight of LabConnect’s new business and network development activities and the company’s Scientific Operations division. Before starting LabConnect, Jeff was Founder and Director of Nexus Health Management International, where he was involved in the development of inpatient behavioral health services in Southeast Asia. Prior to that, he served as Vice President of Strategic Alliance Development for Charter Behavioral Health Systems, Vice President of Operations/Development at Option Care, Inc. and as a Franchise Operations Manager for Medicine Shoppe International. Jeff earned his BA degree in economics from the University of Missouri-Columbia. He lives in Seattle, Washington.

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Ben Booher, Business Development Director and Former Manager of Logistics Support, LabConnect

Ben joined LabConnect in 2008 and has played an important role in the development of LabConnect operations. He has been involved in every link of the LabConnect supply chain and sample cold chain and has developed and managed teams responsible for specimen receipt and accessioning, investigative site support, short- and long-term biorepository functions, and packaging design, development, and validation. In the 6 years prior to his business development role, Ben managed LabConnect’s global logistics network and team of courier partners, growing these international functions to meet the demands of today’s high complexity trials. Ben studied at East Tennessee State University and is based in LabConnect’s Johnson City, Tennessee headquarters; he lives with his family in Erwin, Tennessee.

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