Unable to see what was happening on-site, one sponsor lost many samples. The issue was so severe that the study was at risk of being canceled. However, having used TruLab for another study with great results, the sponsor reached out for help. Within days, the TruLab team joined the study and entirely stopped the loss of more samples.

As a result, the study kept moving forward. TruLab helped the sponsor gain site visibility and better understand the state of their samples.Unable to see what was happening on-site, one sponsor lost many samples. The issue was so severe that the study was at risk of being canceled. However, having used TruLab for another study with great results, the sponsor reached out for help.

Within days, the TruLab team joined the study and entirely stopped the loss of more samples. As a result, the study kept moving forward. TruLab helped the sponsor gain site visibility and better understand the state of their samples.

Background

This sponsor’s Phase 1/2 study examined a therapy for a neurological disease for which no FDA-approved medications exist. At the first activated site in Europe, over 100 samples were either not collected or lost at some point in the chain of custody. Even for collected samples, discrepancies in the data created a backlog of over 300 queries.

In the dark about the activities conducted at the site, the sponsor had no ability to remedy the situation. Without knowing which samples were collected or the timing of these collections, the sample loss and backlog of queries put the rest of the study at risk of being canceled.

TruLab to the Rescue

Midway through the study, the sponsor team asked TruLab to step in to track site activities and samples before enrolling the next cohort. Within days, the TruLab team configured a study-specific app for the site. Since the study was at risk, the sponsor requested TruLab train the site in person for the new cohort.

Within the week, TruLab’s site care team hopped on an international flight and conducted the training before the new cohort’s first visit. The site used TruLab to conduct the visits for the next cohort.

The site staff immediately adopted the software into their daily routine, which provided the sponsor with real-time insight into the site activities and sample data. Since TruLab enabled the sponsor to receive rich, clean sample data from that cohort, they decided to enroll an additional cohort.

Once TruLab engaged, zero samples were lost among the approximately 5,000 samples collected from the two cohorts, a significant improvement from the 100 lost in the previous four cohorts. Additionally, the number of queries dropped dramatically from hundreds to zero for these two new cohorts.

TruLab’s Solutions and Team:

  • Provided the sponsor with visibility into site activities
  • Eliminated sample loss in later cohorts
  • Allowed the sponsor to continue and expand the study
  • Reduced queries and site burden

Conclusion

This Phase 1/2 study needed help. In jeopardy of being canceled due to sample loss, the sponsor’s head of sample management reached out to TruLab to rescue the study. TruLab quickly deployed and saw clean sample data coming out of the site. The sponsor now had visibility into the site’s activities, the samples, and their collection times. As a result of TruLab’s service, zero samples were lost in the last two cohorts, saving the study.

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