Massimo Crudeli
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, labeling, 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 labeling deviations) and waste:
"19 percent of the packaged and labeled 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:
- Respond to changes in dosing levels, formulations, and clinical trial arms
- Support site and patient forecasting
- Create more accurate and efficient supply plans
- Reduce deviations and complaints
- Monitor critical performance metrics, such as lead times, waste, service levels, and cost
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."
Improve Your Clinical Supply Capabilities with the ERP System Built for Life Sciences
Built on the robust foundation of Microsoft Dynamics 365, STAEDEAN delivers the most comprehensive Enterprise Resource Planning (ERP) solution for life sciences organizations.
Our solutions are guaranteed to conform with industry standards and regulations, such as GMP, GAMP5, FDA 21 CFR Part 11, and EU Annex 11.
Our STAEDEAN Clinical Supply Chain ERP maximizes clinical trial logistics by improving order accuracy, shipping efficiency, packaging, and labeling, and managing and analyzing 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 STAEDEAN Clinical Supply Chain ERP solution 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 STAEDEAN Clinical Supply Chain ERP, 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.
STAEDEAN 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 complex clinical trials
Massimo Crudeli