The recent Clinical Supply Forum in Durham, NC, brought together clinical trial professionals from large pharma companies, CMOs, packaging component manufacturers, distribution service providers, and other clinical support service providers.

Clarkstno Consulting led a discussion on how serialization requirements will impact the clinical supply chain. Even though full item level track and trace is not required for 10 years, clinical trial sponsors should be aware of the Drug Quality and Security Act, considering the implications it may have on their business.

By the time a pharma company becomes fully compliant, they will have spent millions of dollars on software, equipment, and validation. Once you add in less tangible costs related to training, documentation, and general operating model changes, you’ve made a significant investment to remain compliant. So, how can clinical supply organizations utilize, and benefit from, these mandatory infrastructure investments?

Consider this: in basic terms, many of the requirements for commercial serialization and track & trace are already embedded into clinical supply processes. Unfortunately, the compliance methods currently employed in the clinical world tend to rely on labor-intensive processes, spreadsheets, and paper-based systems. These processes require significant and constant effort, and are prone to human error. Clinical supply organizations should investigate ways to leverage serialization and track & trace infrastructure in order to reduce effort, cost, and risk of errors.

Potential examples of how to benefit from the serialization and track & trace infrastructure include:

• Better coordination of clinical supplies across multiple sites. When last minute changes pop up (and they do!), increased visibility can facilitate movement and avoid missed opportunities.
• Expiry dating control. Clearly understanding which product expiry is available at all times will reduce waste and improve forecasting.
• Importing & Exporting. Increased sophistication can reduce delays and holds when shipping internationally.

Your company will be forced to spend large sums to comply with serialization and track & trace requirements. While there are notable commercial benefits, they wouldn’t necessarily tip a cost benefit analysis towards a voluntarily undertaking. By leveraging this investment throughout other areas of the business, your company can create opportunities from a sunk cost.