This article first appeared in the Summer 2016 issue of The Record.
Today’s clinical trials involve more patients, more sites, more countries and more uncertainty than ever before. The number and complexity of issues affecting the supply chain for these trials has also grown to include costly comparator drugs, intricate protocols, delicate investigative compounds, adaptive clinical trials and variable dosing schemes. Add in stricter country-specific regulatory requirements regarding controlled substances, temperature-sensible products, packaging, shipping and labelling, and it becomes clear that supplying drugs for clinical trials involves more than simply manufacturing them.
To ensure they can rapidly adjust to changing client demands during complex and geographically dispersed clinical trials, life sciences and pharmaceutical companies need to improve how they forecast, manufacture and distribute drug supplies. This can be easily achieved by implementing an integrated enterprise resource planning (ERP) solution that can standardise the processes involved in clinical trial management, while ensuring the products can be delivered on time, efficiently, and cost effectively. Integrated ERP solutions can also synchronise the manufacturing processes for active pharmaceutical ingredients and drug products with the demand of dispensable units.
Built on Microsoft Dynamics AX, the AX for Pharma Clinical Supply Chain module allows pharmaceutical companies to manage clinical manufacturing, weighing and dispensing, quality control, inventory, and clinical packaging and labelling processes. The platform also enables consistent control of products, programmes, candidates and protocols.
Aligning drug supply with demand is easy with AX for Pharma. Users can gain visibility into demand at a programme, candidate and protocol level, enabling them to rapidly adjust forecasts and manufacturing and distribution processes as changes are made in terms of patient enrolment, the number of sites and dosing schemes.
Integrated ERP solutions allow supply chain leaders and project managers to track inventory and deliveries quickly, which is crucial when a trial involves investigators and depots in multiple geographical regions, each with their own import and export restrictions.
AX for Pharma allows everyone in the supply chain to track lots and containers as they are moved between domestic and international warehouses. Integrated ERP solutions support the management of controlled substances, temperature-sensible products and tamper evidence seals, and facilitate collaboration with third-party logistics providers.
As clinical trials involve an increasing number of countries, sites, investigators, patients and products, integrated ERP solutions, such as AX for Pharma’s Clinical Supply Chain module, will become highly valuable for helping companies to boost efficiency, while remaining compliant.
Massimo Crudeli is the senior manager and solution architect at AX for Pharma
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