A missed step could have rendered nearly two years of biomarker data unusable.
Because of TruTechnologies' timely intervention, the sponsor was able to work directly with the site to ensure this sample was recollected prior to dosing and this patient’s baseline data could be used. Had TruTechnologies not alerted the necessary stakeholders, this baseline sample and 96 weeks of subsequent enrolled biomarker data would have been lost.
To gauge the efficacy of treatment, cerebrospinal fluid (CSF) samples needed to be collected from each patient prior to dosing. Sites were instructed to collect the samples during the patients’ baseline visit and then process them locally before shipping to the central lab.
At this particular site, however, two vials of CSF were indeed collected, but only one was sent on to the in-house lab for aliquoting and testing as part of the patient’s standard of care. Since this was a baseline visit, failing to catch this error before dosing would have led to the patient’s data being discarded.
When no shipment for the central CSF sample was logged, a TruTechnologies site partner reached out to the site directly and learned of the protocol deviation. Rather than aliquoting, freezing, and packaging the second sample for shipping as instructed in the lab manual, the site simply froze the vial upon collection.
Once the sponsor was made aware of the mix up, they instructed the site to bring the patient back in for a redraw. The site quickly rescheduled the visit within the baseline window, allowing a new sample to be taken so the patient’s data remained valid for the study.
The TruTechnologies solution and team:
• Provided real-time visibility into daily site activities.
• Identified and escalated a critical protocol deviation.
• Prevented far greater patient burden by enabling the baseline data to be recorded before dosing occurred.
Without TruTechnologies real-time monitoring of the site’s daily logs, it likely would have been months before the sponsor was made aware of this patient’s missing baseline data, at which point it would have been far too late to remedy the situation.
TruTechnologies' prompt intervention enabled a necessary course correction within hours. This ensured the patient’s continued participation wasn’t wasted and that the critical biomarker data remained viable for FDA submission in this registrational trial.
