Advanced data monitoring technology is increasingly essential for keeping costs down and supply chains in order. ELPRO prepares for a new era in clinical trial logistics.
As pipelines fill with more temperature-sensitive investigational medicinal products, clinical supply chain managers are faced with increasing challenges. Making quick product-release decisions and effectively managing CROs are vital everyday activities. Outdated practices of reviewing temperature data by hand, manual data entry and archaic reporting methods can slow things down, costing trial delay and potential product loss.
What's more, for global supply chains, nothing is cohesive between the numerous receiving clinical sites: CMOs use different temperature monitors and separate reports created in unrelated systems. Shipments are sent with a data logger to record temperature and ensure product quality, but what if the product owner doesn't get feedback, or data, from the receiving site? How quickly are any temperature excursions communicated, and what is the procedure for deciding whether or not to release the product for clinical trials?
GDP requirements
There are more than 40 GDP regulatory documents around the world. They underline certain requirements for pharmaceutical manufacturers to provide evidence to customers and regulators that temperatures were within specification during transport and storage of clinical materials and products.
EU GDP Chapter 9.2 describes transportation mapping and qualification: "Risk assessment of delivery routes should be used to determine where temperature controls are required. Equipment used for temperature monitoring during transport within vehicles and/or containers, should be maintained and calibrated at regular intervals at least once a year."
Static temperature monitoring is therefore no longer a viable option; simply throwing a data logger in a box will not create an audit trail and the level of control sought by regulators to meet GDPs.
The result of the aforementioned new regulatory requirements, coupled with pharmaceutical manufacturers driving out costs and inefficiencies, is the transition of most companies to the modern world of data monitoring. Sophisticated temperature monitoring devices have longer memory, are more accurate and much easier to use, and can be programmed with up to 18 indices of product or shipment-specific data. This is useful if you have extensive stability data that you can use to program devices and set multilevel alarms.
There are user-friendly PDF data loggers that allow for a 'one-step' download of information at the destination, without software, that generates a report that includes easy-to-read temperature graphs with embedded data, in a single file. This PDF can simply be emailed to any desktop worldwide, or to a central database.
Lundbeck's senior clinical supply technician Lisbeth Nielsen uses ELPRO's LIBERO PDF Loggers. "My team defines the temperature profiles using available stability data, then site personnel download the profile at point of receipt from depots," she says. "What's nice about the LIBEROs is that we can control what information is seen by whom. The clinical sites only see if there's an excursion, or not. This cuts down a number of unnecessary steps in confirming product quality and administering it to the trial patient."
One step further after using new temperature devices to simplify end-to-end data handling processes is to collect and use the information. Software as a service (SaaS) platforms are allowing users to log in and access data from anywhere in the world. QA managers control access to their data in a secure cloud environment and are able to run customised searches on their shipments.
Marilda Bezerra, a GDP industry professional who uses ELPRO's liberoMANAGER database explains: "We wanted a system in which the alarm limits and configuration profiles would be centrally managed by quality. We wanted data loggers, which enable the recipients of the goods to identify quickly whether there was a temperature excursion during the shipment or not, in order to place only the pallets with alarms under quarantine.
"In addition to that we wanted a system that would support us not only with the temperature monitoring, but also with the review of our transportation routes, temperature control measures, and freight forwarder performance versus SOP."
Fear of change
If the benefits of implementing a new data monitoring system are clear, why aren't more organisations making the shift? The cost of change can create major stumbling blocks, including physical cost (new equipment and purchases required for initial set-up and organisational cost (man hours, new SOPs and training supply-chain partners).
But what about the cost of not changing? How long can clinical sites continue to discard products that are subjected to inadequate monitoring and storage? In addition to business implications such as loss of product, reproducing and reshipping medicines; there are also ecological aspects of unnecessary waste including additional transport pollution and extra pharmaceutical waste.
Can you put a price on errors? Companies often only look at tangible numbers when implementing new systems, such as devices, service, software, and database costs. Instead, companies should calculate the costs not to change. Too often, data disappears, due to the data loggers being unread, lost or disconnected. Without data, action is delayed, incurring significant hidden costs.
Advancing data management practices
Being able to access all shipments' temperature data centrally opens up opportunities for companies to gain tighter control of their temperature control supply chain. For example, being able to compare total deviation time with product specific requirements can help avoid costly product loss. Some companies call this managing a stability budget, calculating total time out of refrigeration across multiple legs in a supply chain, or adding deviation time across shipping, handling and storage.
Technical Report 53 of the Parental Drug Association (PDA) recommends this approach as best practice: "Use scientific data and rationale necessary to determine an appropriate stability budget for a drug product over the entire life cycle of a product."
This becomes very important when releasing a product at destination is questionable.
"Right now we manually calculate total time out of refrigeration against allowable excursion time," explains Takanori Aasberg Miyashita, system manager temperature control at Novo Nordisk. "The challenge is adding up all deviations across the different supply chain 'levels'."
For Novo Nordisk, advanced data management would be integrating clinical study data with shipping and temperature data. "We have discussed the possibility to integrate communication between IVRS and data loggers with the suppliers, because this is an interesting perspective," continues Miyashiti, "however no concrete projects are planned at the moment."
Though companies' approaches and goals for temperature data management may vary, one thing is for certain across the industry: modern data monitoring technology today can help reduce substantial hidden costs, simplify end-to-end data handling and bring your clinical cold chain into compliance.
