A missing kit nearly led to skipped sample collections — until real-time monitoring uncovered the issue and saved the visit.
Due to an internal miscommunication at the site, the coordinator incorrectly believed he did not have the proper kit to collect critical time-sensitive samples, and as a result, was choosing not to do the draws. Because of TruTechnologies' immediate intervention, the situation was remedied while the patient was still on-site, preventing the loss of this patient’s data and minimizing burden.
A sponsor of an in-flight oncology study brought TruTechnologies in to track critical ambient samples requiring same-day shipment to the specialty lab. These peripheral blood mononuclear cell (PBMC) samples are imperative to study data. With such a short window, any minor errors in collection can derail the viability of these precious samples, making sponsors anxious and placing additional burden on patients.
Common errors include skipped or late collections, inability to ship out same-day, courier delays, or weekend deliveries. For example, the site does not have the correct corresponding kit as a patient comes in. The coordinator could:
1. Cannibalize other kits;
2. Contact the CRA to escalate and request guidance;
3. Reschedule the visit, adding significant patient burden and potentially deviating if the visit is out of window;
4. Or skip the assessment.
In this instance, the coordinator chose option 4, risking the patient’s data and potential inclusion in the study. Given that this site had previously struggled with the Week 1 visit, TruTechnologies' monitoring team was already keeping a close watch. This visit was particularly complex, requiring multiple time-sensitive samples — both pre- and post-dose — collected over a six-hour period.
During the visit, the coordinator contacted TruTechnologies to confirm which lab to ship separate PK samples to. In the course of the conversation, however, he casually mentioned a bigger issue — he didn’t have the proper kit for the visit and planned to skip most of the required draws.
He had alternative tubes for PK plasma but not for the PBMC samples, which were critical to collect and ship quickly. TruTechnologies escalated the matter to the central lab and assigned CRAs within minutes, all while the patient was still on-site. The central lab confirmed that the correct kits had, in fact, been delivered to the site — but to another building.
By making the issue visible to the CRA and other site contacts, TruTechnologies facilitated the delivery of the correct kit to the coordinator while the patient was still there. This swift intervention saved the visit before the patient left.
Without TruTechnologies' real-time oversight during the visit, the patient would have left the site without having the vast majority of required samples taken.
TruTechnologies' team:
• Notified both the sponsor and CRA of the potential deviation within minutes, while the patient was still on-site.
• Leveraged other relationships at the site to obtain the correct kit for the coordinator performing the visit.
• Ensured all remaining PBMCs were collected per study protocol, saving this patient’s data and potential inclusion in study.
