Rob Montague: The regulators involved in EU GDP, like many regulatory bodies, continue to evolve their thinking in the temperature monitoring and product exposure space. GSK has chosen to focus on quality for the patient as a key driver. Many companies apply the term 'risk-based approach' to their decision not to monitor products in transit in certain lanes or at certain times of the year. At GSK, we've demonstrated that the vagaries of transportation can cause amazing excursions when logic dictates the shipment should be at low risk. Our definition of risk-based, therefore, revolves around monitoring 100% of our non-cold-chain shipments, but varying the amount of packaging based on the actual weather and having the dispatch team understand the robustness of the stability information around the products.
RM: Our risk-based approach incorporates information from the stability testing to indicate an alarm on a product. In most companies, once an alarm is received, the first action is to assemble the data from the shipment and then compare it with the stability information to assess the viability of the product. We have switched the order around, so we actually look at the stability information before an alarm is received. When there is an alarm, we know within seconds of the consignee knowing.
RM: Historically, temperature monitoring models only fed back when there was an issue. To draw an analogy to the safety world, it's the equivalent of only reporting accidents rather than watching near misses to understand how something more serious could happen. Having the data available at the destination and origin allows instant access to regulators. Niclas Ohlsson: From our perspective, having the data from all shipments means we can analyse how well the organisation adheres to the corporate SOP.
RM: TSS enables customers to access the data in an intuitive and simple manner. We have integrated TSS with our order management system to ensure aligned and complete data. FDA has been public about its increased focus on data integrity, and EMA has a requirement for a trial master file to enable transparency across the myriad systems required to manage a clinical trial. While it's easy to say we have adequate data integrity, you can prove it when you can line up supply chain transactions and demonstrate a logical flow to the data that matches the physical process.
RM: The centralisation of the historical data means that we can overlay multiple shipments in the same lane and see patterns. The availability of trending data has directed conversations with the logistics providers about handling processes where there are distinct trends that are not yet excursions. The data, properly analysed, allows us to be proactive rather than reactionary.
NO: The latest technologies allow our customers to go beyond reporting, to interact with the data in different forms and methods. What's more, they can analyse it directly in TSS the same minute a logger is being uploaded to the cloud. TSS data integration allows customers to aggregate all relevant data from different sources, for example, SAP and freight forwarders, and to present this in one single, collaborative view.
The data captured during transport allows companies to distribute the costs of trial kits effectively and to ensure that the studies' results rest on the correct information about the drug's efficiency. For the patient, whose last hope for cure might rest on a specific drug, the right information is critical to ensuring an effective, fully active drug is delivered in the first instance.