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    Safeguarding Your Study Against Biologistics Surprises

    Best Practices for Managing Multi-site Biotech Research Studies

    Clinical Operations Managers can minimize unforeseen challenges by instituting a few key operational standards in their biologistics program.

    Every Biotech research study poses an array of challenges. However, the pace and complexity of today’s multi-site studies, which can span 2-3+ years, creates unique biologistics challenges, including:

    • Timing, frequency and distribution of supply shipments
    • Expiration and lot-to-lot accountability/tracking
    • Managing supply shipments to minimize budgetary impacts
    • Monitoring the movement of temperature-sensitive shipments

    Here are 3 ways Clinical Operations Managers can address these challenges and minimize biologistics surprises that can derail or invalidate important research:

    1) Utilizing Technology-Driven Specimen and Supply Management Programs

    Sophisticated inventory management and scheduling programs provide the benefits of real-time accountability and just-in-time delivery of specimens and clinical supplies. Clinical Operations Directors who have the ability to monitor enrollment velocity and the timing of future study visits can wisely plan for and schedule distribution, thereby minimizing unplanned shipments and related surcharges that can cripple a study budget.

    At ProMedDx we utilize a next-generation inventory management system that closely monitors usage and dependent supply requirements and schedules just-in-time distribution of supplies and specimens to their destination. One of the key features of our program is a tracking tool that allows us to identify and recall assets and compliantly manage the return and replenishment in real time. This is helpful for those conducting studies involving biospecimen collection in which tube expiration may vary between lots and by tube type. These types of variations can create an array of tracking challenges if they are not accurately managed and can even invalidate a study.

    You don’t have to partner with us, but be sure whichever vendor system you do choose enables proper tracking and efficient distribution of supplies—the foundation of your current and future research.

    2) Accurately Tracking Biospecimens from Site to Storage

    A reliable chain of custody is critical for ensuring the integrity of valuable biospecimens and other study materials at every stage, from the point of collection through transport and into storage.

    Technology enhancements that can accurately track the movement of biospecimens while minimizing risk to your assets include barcoding, electronic requisition forms and GPS tracking. Employing all of these technologies in an integrated biologistics platform as we do at ProMedDx results in a solid chain of custody and maximum visibility of the biospecimen journey.

    3) Maintaining Direct Communication With Your Biologistics Team

    Using technology to track the location and condition of your specimens is only part of the solution. It is also invaluable to have a team of dedicated logistics specialists who are trained to use the technology and experienced with temperature-critical shipments. When necessary, a properly trained logistics team can triage a shipment in real-time by adjusting its itinerary and/or re-icing the shipment at its connection.

    Clinical Operations Managers who proactively address these three areas will have more confidence in their biologistics programs and, ultimately, in their ability to support important research.

    Trying to manage all of these biologistics tasks in-house can be expensive and risky—especially if your team does not have the technology or experience needed. Partnering with a team of trusted experts can free you from worrying about and managing complex details and unpleasant surprises that cost money and research time.


    At ProMedDx, we have more than 20 years of experience in Biologistics managementContact us to learn more about how we can support you with on-demand retrieval and shipment while maintaining a reliable chain of custody.