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A Remote-Based Approach to Ensuring Dosing Compliance And Drug Accountability
For one global pharmaceutical company’s pivotal Phase III oncology clinical trial, onsite pharmacists were required to mix the patient doses for delivery via infusion using unblinded drug supplies provided in multiple strengths.
The prescribed dosing was based on the patient’s weight, and treatments were administered over a four month period. The study duration was two years and was being conducted in more than 100 sites across 17 countries.
Oncology clinical trials involving weight-based dosing and delivery via infusion put the onus on site pharmacists to prepare, administer, and document the proper dosing.
Almac Clinical Services was responsible for ensuring accountability of the investigational and comparator drugs throughout the clinical trial in a way that was quality based, streamlined and cost efficient. This involved proactively collecting, reviewing, and reconciling temperature logs, drug assignments, and patient dosing records. The Almac approach decreased site monitoring costs, by providing a centralised remote solution.
Over the course of the study, Almac’s Clinical Services team reviewed 15,000 drug assignments and thousands of patient dose worksheets, drug accountability logs, and temperature logs. These logs accounted for over 300,000 data points. The streamlined process performed routinely as the study progressed, allowed the sponsor to close the study promptly, without the holdup that drug accountability usually presents when it is performed as a last step.
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