A TrialClarity alert is received by trial management team personnel that participant dosing is falling behind protocol schedule. TrialClarity determines this by comparing the dosing schedule set by the trial protocol with the trial site Case Report Forms (CRFs) filed in the Electronic Data Capture (EDC) system; it can detect longer than specified intervals between the dosing reports as well as any missed dosing.

TrialClarity notifies those responsible on the management team so they can quickly review the current TrialSignals being monitored in search of the root cause. Using TrialClarity’s data visualization tools, the management team can see that the issue seems limited to one geographic region of the trial and to a few sites in one city in that region.

Using TrialClarity, they make an inquiry of the Principal Investigator of the sites involved via email, and it is discovered from the replies that there have been delays in receiving supplies of the trial drug at these sites. Inquiries are then made via email to the trial supply logistics unit and the shipper being used. The replies include records of replenishment requests from the sites and shipment/delivery documentation.

After investigation by the trial management team, it is discovered that an air express shipment of the drug was held up due to weather delays and as a result exposed to excessive temperatures in transit. This caused it to be discarded and a replacement shipment sent by the logistics unit, delaying supply to this city.

As a result, the trial management team works with the logistics unit to implement new measures to ensure that drug shipments to all trial sites are maintained at required temperature despite delays en route.

The TrialClarity EventChain feature captures a permanent record of all emails, CRFs, meeting notes, shipping records, findings, and CAPA actions taken for this incident. This record becomes a valuable source of insight for running the current trial, responding to FDA queries about the deviation from protocol, and responding faster to similar issues in the future. The speed with which the deviation was detected by TrialClarity gave the management team the opportunity to put a correction in place quickly enough to avoid repetition and invalidation of trial data and kept the trial on track to its scheduled completion.