The clinical-trial supply process can often be a very disjointed one, with trial drugs coming from one location, comparators or placebos from another, and a clinical operations group handling the intake of trial participants while the clinical logistics team (and multiple logistics providers) handling the physical distribution. Now Almac Group, a leading clinical development and manufacturing organization, is bringing clarity to the process with its Almac ONE service. Almac ONE is global, across Almac’s multiple locations; and is set up to be a closed-loop operation with outbound and inbound product movements, all managed from a central IT system.
Almac ONE has been months in the making, according to Tony Cecil, program manager, and Almac’s global operational footprint has expanded in key markets in recent years to meet the evolving needs of clinical trials. “The big challenge with clinical trials is ensuring that sufficient trial materials are sent to where they are needed, based on how patient recruitment is proceeding,” he says. “By integrating the patient data with the supply data, we can align the two, preventing both material shortages, or wastage from misdirected supplies.”
Almac ONE includes its proprietary interactive-response system, IXRS, along with programs for managing supply inventory and forecasting. This IT platform is backed by a dedicated team of subject matter experts. The platform scales well, says Cecil, being able to handle large global trials with thousands of participants, as well as small specialty trials in one country or region. As long as Almac handles the packaging, labeling and distribution, it can work with any drug developer’s trial materials.