TruLab’s around-the-clock watchful eye helps keep clinical sites on track, even on Christmas. On Christmas morning, TruLab alerted a clinical site half-way around the world of an anomaly during a patient visit.

In the course of alerting the site, TruLab surfaced unnecessary 4- hour and 8-hour PK samples the site was about to collect. As a result, a young boy not only avoided extra blood draws but also went home much earlier than expected.

Background

This study involved pediatric patients with a rare genetic condition commonly leading to a significantly shortened lifespan, among other severe symptoms. The sponsor deployed TruLab at clinical sites to monitor samples, deviations, and provide support as the visit occurs.

To ease patient burden, a recent protocol amendment eliminated the 4-hour and 8-hour PK for a visit later in the enrollment period. Clinical sites can sometimes overlook subsequent amendments and conduct visits according to previous versions of the protocol, including material changes to the schedule of assessments.

TruLab Prevents Protocol Deviation

On this particular visit, a little boy went to the clinical site and was set for a long day with an IV in his arm followed by hours of blood tests. Prior to the amendment, the schedule called for blood draws of PK samples that ended 8 hours after the infusion.

As the boy began his visit, TruLab detected an anomaly. As TruLab spoke with the site, they discovered this site missed the recent protocol amendment which eliminated the last two blood draws at the 4-hour and 8- hour timepoints, and they were intending on collecting those samples.

TruLab informed the site of the amendment, making for an easier day for the boy and turning a potentially 10-hour visit into 3 hours. Because TruLab’s technology and monitoring services prevented this deviation, instead of spending all day at the clinical site with unnecessary blood draws, the little boy got to go home early.

The impact of TruLab’s in-depth protocol adherence and timely alerts:

  • The young boy avoided unnecessary samples and time at the site
  • TruLab notified the site of the most recent protocol amendment
  • TruLab prevented a protocol deviation before it happened

Conclusion

Sites can easily misinterpret protocols or miss subsequent protocol changes amid everything else happening at a site. TruLab ensures everything complies with the latest protocol amendments, guiding sites through the correct collections. The TruLab monitoring team not only catches deviations as they occur but also prevents the mix-ups from occurring in the first place.

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