Digital solutions can lead to faster drug launches, better patient and investigator experiences, and savings
Clinical trials have been increasing in number and complexity. At the beginning of 2023, a record-breaking 38,837 active clinical trials were being conducted in the United States alone.
Such staggering numbers have an impact on the logistics involved in producing, labelling, and distributing investigational medications. Sophisticated logistics systems are becoming more important than ever, and, according to McKinsey, can lead to faster drug launches, better patient and investigator experiences, and cost savings of 15–20%.
While McKinsey found that the industry has been performing well when it comes to on-time delivery and temperature excursions, room for improvement exists around quality issues (packaging and labelling deviations) and waste:
“19 percent of the packaged and labelled kits had deviations, and 7 percent
gave rise to complaints…The median waste level for investigational medicinal
product (IMP) kits was a troubling 50 percent, primarily due to poor forecasting
and planning, representing a significant opportunity to capture value. For
instance, a pharmaceutical company spending $10 billion a year on R&D could
reap annual savings of more than $100 million by improving its waste performance
to best in class.”
To achieve operational excellence and establish new capabilities for growing clinical trial areas like cell and gene therapies, McKinsey urges Pharmaceutical companies and Biotech firms—and their CDMO partners—to ensure that their “digital maturity is adequate to enable end-to end-performance, transparency, predictive forecasting, and supply optimization.”
With greater control over data collection, management, and analytics from sourcing through distribution, drug makers conducting clinical trials will be better able to:
According to McKinsey, Interactive Response Technology (IRT) and Enterprise Resource Planning (ERP) systems can be critical to successful clinical trial logistics:
“One leading Biotech has begun its journey to integrate IRT, RapidResponse,
and enterprise resource planning systems while building an automated
exchange mechanism with logistics service providers. This initiative is delivering
greater flexibility, lower costs, and better investigator and patient experiences
through improved decision-making and insight generation.”
With plug-and-play modules built on the robust foundation of Microsoft Dynamics 365, AX for Pharma delivers the most comprehensive Enterprise Resource Planning (ERP) solution for Life Sciences organizations.
All our supply chain management, quality management, and warehouse management solutions are guaranteed to conform with industry standards and regulations, such as GMP, GAMP5, FDA 21 CFR Part 11, and EU Annex 11.
Our AXP365 Advanced Warehouse Management™ and AXP365 Clinical Supplies™ modules work together to maximize clinical trial logistics by improving order accuracy, shipping efficiency, packaging and labelling, and managing and analysing data—across sites in multiple geographies—related to subject selection, randomization and blinding, collection schedules, etc.
For complete supply chain synchronization, Pharma companies and CDMOs can use the AXP365 Clinical Supplies™ module to map the manufacturing, packaging, and distribution networks. related to each clinical study. Our integrated solution enables better clinical supply forecasting and planning, and greater visibility means you can identify and address issues faster to eliminate supply disruptions, save time, and optimize inventory levels.
Our solution manages full traceability of product movement from warehouse to warehouse and site to site across the world. The module also enables full traceability of dispensable units, which is required to ensure patient safety, protect products from fraud and counterfeiting, and improve production efficiency.
With AXP365 Clinical Supplies™, you can track lots using unique sequence numbers and trace goods by expiration date using barcoded labels. The item-tracking functionality allows you to retrieve the forward/backward history and full genealogy of each lot, including all manufacturing and transaction details.
AX for Pharma has been building ERP solutions for Pharmaceutical, Biotech, and Medical Device companies on the Microsoft Dynamics 365 and Microsoft Dynamics AX platforms since 2008. To learn how we can help your business keep up with the decentralization and complexity of today’s clinical trials, please contact us today.