In the supply chain, temperature-monitored shipments play a crucial role in the distribution of drugs to patients. They involve numerous stakeholders, each with their own role to play, in what is a largely intricate process. With the risk of temperature excursions potentially detrimental to the outcome of a trial, ensuring each player is aware of their responsibilities is key to its success.
In this Industry Viewpoint, CTA Editor Henry Kerali sits down with Henk Dieteren, who’s the Senior Clinical Supply Manager at Grünenthal. An experienced professional, Dieteren co-oversees the strategic direction of the Clinical Trial Supply department, involving vendor qualification and the setup of IRT systems.
Here, he discusses a case study in which he implemented an automated receipt process for temperature-sensitive shipments.
Henry Kerali: Can you provide an overview of your case study – what is the automated receipt process?
Henk Dieteren: At Grünenthal, we implemented a new automated process in a pilot study that enabled us to track shipments more efficiently. In the past, we had a lot of trials involving temperature-monitored shipments, and oftentimes we weren’t immediately made aware of potential excursions or missing temperature data. Consequently, the in-time evaluation of the excursions came on a highly critical path before the concerned kits were assigned to subjects. This occurred mainly for shipments, as well as for storage at investigational sites.
That brought me to the idea of putting an automated process in place that does not allow an investigational site to handover kits where temperature data isn’t available, or where there are excursions. Nowadays with all the technology available to the industry, such as IRT, it should be possible for multiple systems to talk to one another. Automated systems should be in place whereby investigators are alerted when there’s a fault with the shipment and advises the kits cannot be distributed. That in a nutshell is how the process works and was implemented.
HK: What were some of the unique challenges you faced in setting up this process?
Dieteren: First of all, we needed to look for parties that were willing to disclose their processes to one another. When talking about system integration, each party must know the ins and outs of certain systems while understanding their strengths and weaknesses.
The parties involved – Catalent, Suvoda and Berlinger & CO, AG – needed to be open to each other and put their cards on the table. For instance, if Party A needs ‘X’ as an input and Party B needs ‘Y’ as an output, then it needs to be established whether or not both parties can deliver. I would say this was a key stage before determining how systems could be integrated. In total, it took a year before all parties involved reached a stage where the process could really take-off.
The IRT system needed input from both the depot and the temperature system which temperature monitor was associated with which shipment, which shipper box and which kit. Therefore concerned systems needed to be integrated and data points needed to be coded in order to have the right information available at the point the investigational site had to acknowledge the receipt of the concerned shipment.
If, for example, a temperature excursion occurred or no temperature data were available for a certain monitor, the IRT did not allow the recipient to proceed with the acknowledgement, and an alert was fired to the assigned CTS staff.
HK: How do the results from the pilot clinical trial compare with studies not using an automated process?
Dieteren: I did an analysis of 4000 shipments for all IRT-managed trials we have conducted in the last few years. For this pilot study, we had 65 shipments with 39 of them contained temperature monitors. Of the 39, eight were automatically quarantined, and from that point, authorized CTS staff were subsequently notified. Based on the verified temperature data, we were able to release the kits that same day.
If I now look to the forecast, from the 4000 shipments, 93 had excursions in total. There were many issues reviewing the data because we were not necessarily aware there was something wrong. On average, it took 29 days to obtain and evaluate the data, while determining what kits could be used. This was because there were no critical excursions or any need for resupply. You can imagine, in those 29 days, some of the kits could have been assigned to subjects. That was the biggest concern that led to this automated receipt process.
HK: What advice would you give to industry professionals looking to adopt an automated receipt process for temperature-monitored shipments?
Dieteren: For sponsors that distribute temperature-sensitive products, I would strongly advise implementing some form of automated receipt process. That said, inspectors and authorities are paying more attention to temperature monitoring and ensuring all precautions are put in place.
For instance, if a label says ‘ambient’ and should be stored between 15-25°C then the sponsor should consider how it can ensure the shipment will stay within the ambient range. Furthermore, sponsors should also put a contingency plan in place in the event the product falls outside the required range. These are the major concerns of which sponsors should be aware.
Going forward, when I look at the industry, 10 years ago all the rage centered on the need for detailed drug accountability, and the role of IRT systems became ever more integral to the supply chain. In the next few years, I see automated receipt processes having the same impact on the drug development landscape.