Managing Clinical Trial Supplies Over the Holidays:

The holiday season brings a unique set of challenges for clinical trials. While patients participating in research studies continue their treatment, the logistics of ensuring study drugs and supplies are delivered on time can be complex. Investigational sites, depots, and suppliers often reduce operations during this period, making it critical to plan ahead.

• Site and depot closures: Many sites and depots shut down or have reduced staff over the holidays, making it harder to fulfill last-minute supply orders.
• Blackout periods for controlled substances: Regulatory restrictions often prevent shipments of controlled substances during the last two weeks of December. This means all drugs must be at the site or with patients before these blackouts begin.
• Increased competition for shipments: With multiple sponsors pushing orders at the same time, delays are common. Waiting until the last minute to place orders can lead to missed deliveries.
• Missed doses: Adherence to study drug administration is critical. Missed doses can compromise the integrity of a clinical trial and affect study results.
• Post-holiday backlog: After the holidays, backlogs in orders and shipments can cause delays, potentially disrupting patient dosing schedules.

• Plan early: Review dosing schedules in advance and ensure all necessary supplies are ordered ahead of time. As we approach holiday shutdown deadlines, it’s especially important to trigger shipments in advance, ensuring adequate stock levels at sites before depots and facilities close.
• Update inventory systems: Adjust resupply triggers to avoid shortages and disruptions. Proactively managing site inventories helps prevent last-minute rush orders during the holiday period.
• Communicate with patients: Remind patients about holiday schedules and ensure they have all required medications before the break. This reduces the likelihood of supply interruptions for patients who rely on timely deliveries.
• Anticipate post-holiday delays: Prepare for backlogs by prioritizing urgent shipments and developing contingency plans. This includes ensuring that any shipments expected to arrive at sites during the holiday break will have someone on hand to receive them. Having staff available to receive critical supplies during the holiday shutdown period helps maintain treatment continuity.
• Ensure on-time shipments: Ensure site shipments are triggered ahead of time, well before depot closures, to allow for sufficient investigational product (IP) coverage on-site during the holiday shutdowns. This proactive approach minimizes the risk of shortages during the holiday period.

At Clinical Supply Consulting (CSC), we specialize in managing the complexities of clinical trial supply chains. We work with sponsors and clinical teams to ensure all supplies are delivered on time—even during the holiday season. From planning depot closures to managing controlled substance restrictions, CSC helps keep your study on track, no matter the season.

As you plan for a ‘December to Remember,’ CSC is committed to keeping your trial running smoothly. We take the extra steps to ensure shipments are triggered early, appropriate on-site personnel are available to receive those shipments, and patient care is not disrupted. Contact us today to learn how we can support your clinical supply needs.