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New temperature management strategy ensures GDP compliance and patient safety for large pharma company
A large pharma customer, at risk of non-compliance to GDP, due to a downturn in temperature data collection, approached the Almac Clinical Services team for support and assistance to improve the monitor compliance upload rate at the clinical site.
The sponsor was carrying out a randomised, global Phase II study across 14 countries and 112 clinical sites with patient kits that needed to maintain 2-8⁰C and had limited stability data.
Almac Clinical Services goal was to ensure EU GDP’s were being followed by developing a series of steps that would not only improve the monitor compliance upload rate, but would make this as easy as possible for the clinical sites to carry out.
Download our case study to find out how the Almac Clinical Services team and Almac’s industry leading software, TempEZ™, intervened and drastically improved the sponsor’s temperature data collection.
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