On Christmas morning, a real-time intervention spared a young patient hours of unnecessary blood draws.
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On Christmas morning, the TruTechnologies team alerted a clinical site halfway around the world of an anomaly during a patient visit: The site was about to collect unconsented 4-hour and 8-hour PK samples.
To ease patient burden, a recent protocol amendment eliminated those collections 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.
As a result of TruTechnologies' prompt action, a young boy not only avoided extra blood draws but also went home much earlier than expected.
This study involved pediatric patients with a rare genetic condition commonly leading to a significantly shortened lifespan, among other severe symptoms. The sponsor deployed TruTechnologies' sample management platform, TruLab, to monitor samples, track deviations, and support sites in real time.
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, site staff reached out to the TruTechnologies team to clarify why the app didn’t reflect their planned blood draws. Certain the TruLab app was wrong, they were prepared to proceed with the 4-hour and 8-hour collections — until the conversation revealed they had missed the latest protocol amendment.
Because the TruLab app is always updated with the latest protocol version, site staff had the correct guidelines at their fingertips, ensuring compliance. And because the TruTechnologies team caught the issue in time, the boy’s visit was reduced from a grueling 10 hours to just 3. Instead of spending the day undergoing unnecessary blood draws, he got to go home early.
• The young boy avoided unnecessary samples and time at the site.
• TruTechnologies notified the site of the most recent protocol amendment.
• TruTechnologies prevented a protocol deviation before it happened.
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 TruTechnologies monitoring team not only catches deviations as they occur but also prevents the mix-ups from occurring in the first place.
