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Site Materials & Logistics

    Ancillary Trial Supplies and EquipmentLife-Science EventsSite Materials & Logistics

    Keeping Clinical Trials on Track: Navigating Supply Chains, Tariffs, and Regulatory Shifts.

    by Dan McDonald April 10, 2025
    written by Dan McDonald

    Changes taking place in the United States and internationally may affect the clinical trials landscape in the months and even years to come. Here are a few observations:

    FDA

    The U.S. Department of Health and Human Services is reducing its workforce and streamlining its functions. It released a fact sheet regarding changes to expect, which include a workforce reduction at the FDA. Studies conducted by sponsor companies are largely free of direct impact; however, the FDA’s restructuring may affect timelines regarding approvals of studies and new drugs.

    Tariffs and the Clinical Trials Landscape

    While pharmaceutical products are exempt from the enacted tariffs, medical supplies essential for conducting clinical trials—such as gloves, needles, syringes, and monitors—are not.

    With a temporary 90-day pause currently in place for many tariffs—though tariffs on goods from China remain active—sponsors have a window of opportunity to review sourcing strategies and strengthen trial planning. Imperial remains ready to help teams navigate these evolving conditions.

    Tariffs can potentially drive up the costs of imported goods for at least the short term. They can also drive up the costs of goods imported into other countries worldwide that may be shipped there as part of a clinical trial.

    According to 2019 data from the Congressional Research Service and reported by the National Institutes of Health, the leading countries for medical supply imports in the U.S. are Ireland, Germany, China, Switzerland, and Mexico. Some countries are exempt from additional tariffs for now.

    There will likely be some process-related delays as federal agencies that impact trade and logistics put tariffs in place and ensure enforcement mechanisms are active.

    Clinical trial operations teams will need to be vigilant in assessing the impact of cost and time on their study budgets and timelines.

    As tariff negotiations evolve, it will likely make local sourcing for clinical trials a priority. The research and testing needed to find suitable equipment and supplies may lead to delays in trials as sponsors test and acquire protocol-compliant supplies.

    Our sage advice is always to plan ahead whenever possible to avoid disruption. And it’s even more important today to:

    • Begin trial planning early
    • Add buffer time to study ramp up activities
    • Set aside contingency budgets that are approved and in the purchase order

    Final Thoughts

    As the landscape continues to evolve, each day presents us with fresh developments and opportunities. We anticipate further adjustments and ongoing course corrections. At Imperial, we are closely monitoring these changes and stand ready to guide you through this dynamic landscape, providing tailored recommendations and strategic pivots whenever necessary.

    We encourage you to stay connected with us and share your insights as we navigate this journey together. Your feedback is invaluable; together, we can shape the future of clinical trials. Let’s embrace these changes proactively and drive innovation forward!

     

    April 10, 2025 0 comment
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  • Ancillary Trial Supplies and EquipmentBusiness InsightsClinical Trial Writing and DesignSite Materials & LogisticsTranslation of Study Materials

    How Can You Boost Clinical Trial Management Efficiency When Working with Vendors?

    by Dan McDonald February 26, 2025
    by Dan McDonald February 26, 2025

    Discover how to boost clinical trial management efficiency and minimize pain points for your next clinical study. The Complex Landscape of Clinical Studies The management hours required to oversee the many components of a clinical trial are substantial. Clinical operations teams typically concentrate on several…

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  • Clinical Trial Writing and DesignPatient Recruitment and RetentionSite Materials & Logistics

    Digital Advertising in Clinical Trials: The Real Secret Sauce

    by Mike Lakey January 21, 2025
    by Mike Lakey January 21, 2025

    I’ve spent my entire adult life immersed in media, marketing, and advertising, long enough to remember the days before digital advertising in clinical trials took over. For patient recruitment, sponsors and CROs had little more to rely on than local newspapers and radio stations. They…

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  • Ancillary Trial Supplies and EquipmentBusiness InsightsClinical Trial Writing and DesignSite Materials & Logistics

    6 Clinical Study Blogs Not to Miss

    by William McEwen December 18, 2024
    by William McEwen December 18, 2024

    Our blog team reviewed our 2024 clinical study blogs, and we selected these six worth re-reading. Check them out! 1. Sustainability in Business: Transparency and Keeping Score ESG: Environmental, social, and governance are factors that influence commercial success. Discover how Imperial achieved a sustainability rating…

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  • Ancillary Trial Supplies and EquipmentSite Materials & Logistics

    Clinical Trial Kitting: Avoid Costly Pitfalls

    by Hope Cullen December 5, 2024
    by Hope Cullen December 5, 2024

    Clinical trial kits, which contain necessary items for site visits like sample tubes, labels, and instructions, all conveniently customized by trial and visit, are a staple of clinical trials. On the surface, putting the kits together might seem simple enough, but it’s not. Read on…

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  • Site Materials & Logistics

    International Clinical Trial Printing: Think Globally and Print Regionally

    by Ted Corrigan October 8, 2024
    by Ted Corrigan October 8, 2024

    Get highlights on how the international clinical trial printing vendor you select can impact everything from timelines to sustainability. Imperial supports numerous studies by writing, translating, designing, and printing clinical trial materials for sponsors, CROs, clinical research sites, and research patients. For this blog post,…

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  • Business InsightsSite Materials & Logistics

    Mastering Clinical Trial Timelines

    by Heather Ross August 20, 2024
    by Heather Ross August 20, 2024

    Realistic, well-managed clinical trial timelines are essential to the success and timeliness of clinical studies. Read on for more information about keeping your projects on track. We often say every clinical trial is made up of a million moving parts. The materials, equipment, and supplies…

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  • Ancillary Trial Supplies and EquipmentSite Materials & Logistics

    Picking an Ancillary Trial Supplies and Equipment Vendor: 5 Questions to Ask

    by Alejandro Serricchio July 9, 2024
    by Alejandro Serricchio July 9, 2024

    Ancillary trial supplies and equipment play an essential role in most clinical trials. Selecting, procuring, and shipping ancillary supplies and equipment is a specialty that sponsors and CRO companies may find best to outsource. However, outsourcing is not as simple as selecting a vendor and…

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  • Ancillary Trial Supplies and EquipmentSite Materials & Logistics

    The Clinical Trial Ancillary Supplies and Equipment Universe: Making it Work

    by Dan McDonald June 26, 2024
    by Dan McDonald June 26, 2024

    The clinical trial ancillary supplies and equipment universe is a big one and it’s growing. Are you getting the right supplies to your global sites on time? Read on for more information. The vast universe of ancillary equipment and supplies is made up of a…

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  • Ancillary Trial Supplies and EquipmentBusiness InsightsSite Materials & Logistics

    Ancillary Supplies and Equipment: 3 Tips to Get it Under Control

    by Hope Cullen June 20, 2024
    by Hope Cullen June 20, 2024

    Ancillary supplies and equipment are fundamental parts of every clinical study. The entire process, from identifying and procuring protocol-compliant supplies and equipment to getting them to their international destinations is both a science and an art. But that’s really just the beginning. Monitoring and controlling…

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Imperial Clinical Research Services Blog

Imperial is a global leader in clinical trial solutions and support, specializing in study and site print materials, ancillary trial supplies and equipment, clinical trial translation management, and clinical trial patient engagement.

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