Insights enable cost savings
What does GSK's risk-based approach to monitoring investigational medicinal products(IMP) entail, and why did you adopt it?
Rob Montague (RM): 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. Therefore, our risk-based definition 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.
How do you apply the TSS Cloud Temperature Management Solution as part of this process?
RM: Our risk-based approach incorporates information from 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 product's viability. We have switched the order around, so we actually look at the stability information before an alarm is received. Then, when there is an alarm, we know within seconds of the consignee knowing.
Why is capturing all the data so important, and how is this achieved using TSS Data Loggers?
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. In addition, having the data available at the destination and origin allows instant access to regulators.
Niclas Ohlsson (NO):
"From our perspective, having the data from all shipments means analyzing how well the organization adheres to the corporate SOP".
How is GSK able to manage this huge volume of data effectively?
RM: CCIS, the system TSS offers to access the data, is intuitive and simple. We have integrated CCIS with our order management system to ensure aligned and complete data. FDA has been public about its increased focus on data integrity, and the EMA has a requirement for a trial master file to enable transparency across them yriad 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.
How does TSS help companies like GSK make better decisions and benefit patients through improved performance in the supply chain?
RM: The centralization of the historical data means overlaying multiple shipments in the same lane and seeing 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, adequately analyzed, 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 analyze it directly in CCIS the same minute a logger is being uploaded to the cloud. TSS data integration allows customers to aggregate all relevant data from different sources, such as SAP and freight forwarders, and present this in one single, collaborative view. The data captured during transport allows companies to effectively distribute the costs of trial kits and 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 correct information is critical to ensuring an effective, fully active drug is delivered in the first instance.