CASE STUDY Short Timeline Analysis in France for Subjects at Australian Investigator Sites
Situation
Many clinical trials require monitoring of study drug levels throughout the trial period and subsequent dose adjustments to maintain a safe and effective drug level. ACM-Pivotal’s European facility in York, UK was charged with managing a clinical trial that required samples drawn from 28 investigator sites located in Australia to be transported to France for analysis of drug levels and reporting of results –within five working days from blood draw. The results were crucial for the weekly dose adjustment. The short timeframe for result turnaround, limited analysis availability from the French lab, along with the remote locations of some sites in Australia presented ACM-Pivotal with a logistical challenge.
Objective To communicate effectively with our client, investigator site staff, site monitors and couriers to facilitate timely shipment of samples to the French laboratory. The samples had to arrive at the laboratory prior to the day of scheduled analysis. The results then had to be reported to investigator sites, accessed via ACM-Pivotal’s web-based reporting system LabStar, in time for the patient’s weekly dose adjustment visit.
Solution Drawing upon our logistics experience, a choice was made to select a courier able to offer flexible, customer-focused service whilst remaining within the sponsor’s budgetary constraints. This was an essential starting point.
The location of each investigator site in Australia was handled on an individual basis in order to determine accurate transit times from the site to France. By working closely with the sponsor and site monitors, they were able to schedule the patient visits on appropriate days. Training the investigators in this process and maintaining effective communication with the site staff was crucial to the success of the operation. The support given to investigator site staff to organise sample collections by the ACM-Pivotal project management team was integral to the continued success of the process. In Australia this was particularly important due to the time differences. Effective communication was facilitated by the 24/7 on-call system used by the ACM-Pivotal project management team. Every sample booking, collection and delivery was tracked closely by ACM-Pivotal in order to ensure any delay or problem was immediately recognised and resolved. Benefits
The clinical trial continued uninterupted, thanks to ACM-Pivotal’s successful management of the process. Plus, the client now has the confidence to select investigator sites without concern for geographical location in the future.
By implementing our dedicated, hands-on approach the successful completion of the project highlights ACM-Pivotal’s capability to effectively supervise the transport of samples between global locations within short time frames. |
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