Almac Launches STEMS To Transform Temperature Controlled Shipment Monitoring In Clinical Trials

Temperature excursions can inhibit the clinical supply chain, resulting in investigational products being delayed or quarantined and not made available for immediate use at the study site. Excursions can occur at any point in a global supply chain and often arise as a result of multiple uncontrollable factors.

Almac Clinical Services claimed that STEMS reduces any quarantine time for clinical supplies at study sites, saving both time and money for a global clinical study.

The key features of STEMS include: shipping temperature reports, instant reporting enabling near zero quarantine time, improved inventory management whilst saving time and reducing costs, fully-validated system which is compliant with 21 CFR Part 11 requirements, no return shipments required for devices, saving time and reducing expenditure, fully compatible with a range of browsers and requires little training, automated email notifications sent to predefined users.

The launch also coincides with a new label approval system (LAS), a workflow-based label approval management system. LAS gives users full online review, amendment, traceability and control functionality regardless of geographic location.

Martin Lamb, vice president of global business development at Almac Clinical Services, said: “We have experienced rapid growth in the volume of our controlled temperature shipments in the past few years. Improving visibility and performance in this area is a key goal for Almac, our clients and regulators alike, so the introduction of new, innovative tools has been a core part of our business strategy. By helping our clients achieve these goals, STEMS will be of major interest to Pharmaceutical and Biotech clients.”