Manual Intervention Overrides Interactive Response Technology (IRT) to Ensure Continuity of Care
Pharmaceutical companies sponsoring global clinical trials rely on Interactive Response Technology (IRT) systems to manage drug orders in a way that minimises wastage of expensive products while preventing stock outs that could jeopardise patient safety and clinical trial results.
The sponsor of a long-term, global, Phase III study in gastroenterology needed to closely manage production timelines and resupply orders to its European depots, as bulk supply of the expensive Investigational Medicinal Products (IMPs) was very limited.
An Almac Supply Chain Manager (SCM) was brought in mid-trial to act as Global Clinical Study Manager. The SCM, who was monitoring IRT activity, was on the alert when IMP was released to the system. The release and automated resupply orders by the IRT system took place after business hours on a Friday evening, but that did not stop the SCM from taking quick action.
These automated systems facilitate medication management on a scale that would not otherwise be possible. But, when IRT settings are out of sync with study designs, the system can quickly deplete drug supply. Thorough understanding and close oversight of system settings, the Almac SCM continued to monitor and evaluate all IRT orders produced over a three month period, until the IRT programming was adjusted and many EU countries had completed the study.View Resource
Almac Clinical Services
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