Data control in the clinical trials cold chain

12 January 2018



Balancing risk and cost is a delicate undertaking where controlled room temperature clinical trial shipments are concerned. Lisbeth Nielsen, senior clinical supply technician at Lundbeck Pharmaceuticals, tells Andrew Putwain how proper monitoring improves safety and saves money.


Exactness is a priority in the cold chain. If you want to be able to conduct new trials, then keeping control of your data is vital, especially with today’s decreasing profit margins. The broadening of trials to include the developing world also creates new challenges in terms of climate and distance, increasing the need for effective monitoring systems.

According to senior clinical supply technician Lisbeth Nielsen, running successful trials rests upon four key planks: pre-planning; communication; negotiating with vendors for the best prices; and monitoring and data collection.

Nielsen was part of a team that set up contracts with chief medical officers (CMOs) all over the world and collaborated with chief risk officers (CROs) on distributing investigational medical products (IMPs).

“Around 2010, Lundbeck took in new draft guidelines, and realised it needed to have data for shipments made available, so it could show that it had transported IMPs under the right conditions. I was a part of the group discussing the guidelines before they came into force; we started monitoring ambient shipments for all new studies,” she says.

Bringing the guidelines in slowly guaranteed compliance, while ensuring that costs didn’t jump too quickly and avoiding suddenly overburdening those implementing the changes.

“We didn’t start monitoring all our shipments at once,” continues Nielsen, “but organised it so that we were up and running when the guidelines came into place. Without an effective management strategy, we would not have been in compliance.

“It’s always best to look into finding the most efficient solution for all shipment types and to create less work for users for all the tasks that need to be done.

“Experience of temperature-monitoring all shipments led to the implementing of a new system that now covers every clinical shipment.”

Quality issues

A precise balance must be struck between risk and the cost of issues like controlled room temperature (CRT) clinical trial shipments.

A good way to start is by creating transport stability for every new project and making sure there is availability for each one.

“Lundbeck assessed what temperatures products could be exposed to, and for how long, before there were any quality issues. We started on that to be able to avoid having too many excursions, because in the regulatory guidelines it says we should transport our products within storage conditions, but it’s not that easy and it’s expensive to always do that,” she explains.

“A sensible approach is to be careful when there is no stability data availavble at the beginning of project development. This then ensures that temperature is maintained during shipment. Later in the project development, when transport stability is generated, it might no longer protect the IMP shipments, but only monitor temperature. The quantity of the IMPs must also be considered, since the risk of all IMPs for a study being discarded due to a temperature excursion is avoided by using temperature protection.”

It’s always best to look into finding the most efficient solution for all shipment types and to create less work for users for all the tasks that need to be done.

According to Nielsen, the company will save money by using secure shipping, because very few shipments will be affected by temperature excursions.

“The more we send, the more we control,” she continues. “It depends on the amount of IMP we ship, and where we are in the project development. Then, of course, it also depends on the storage conditions, because we are not going to take any risks when a product needs to be kept at 2–8°C.”

Strong and stable

Developing stability data upfront before trials begin is necessary, as all products are affected by temperature and humidity. Analytical departments use these results to determine the storage conditions and the expiry of the IMP. The data is also used to determine transport stability.

The data that is created for this is through transport stability protocols. The programmes should be run according to the guidelines.

“We are not looking into anything about transport routes, countries and so on,” says Nielsen. “We base our decisions on shipping after analysing trends in all the available temperature data, and adjust the methods if necessary. The data shows that there have not been many excursions where the allowed temperature intervals are exceeded during transport of IMPs.

It’s not that we don’t think the system is OK, but it would be easier if data could be transferred with the press of a button, and with less human interaction.

“Most of the products are to be stored under ambient conditions, and that is also a major reason why it is easier to limit the number of temperature excursions.”

This data is important, as it can help if things should go wrong during shipment. “Obviously, we cannot control if IMP is left outside and it’s 50°C,” says Nielsen, “but the likelihood of that is low, and, of course, depends on the countries that we are sending to. Not much gets sent to tropical countries, because there aren’t many with clinical trials sites.”

This may change in the future, as the global economy shifts to the east. In 2017, the Chinese pharma and clinical trials industry made several major changes to its framework to accommodate easier working practices – from changing the amount of foreign medicines in its markets, to new deals with couriers and huge investments in ports.

Improving the improved

The fate of cold chain will change as the industry itself changes, with commercial forces driving new ideas. “I would like to see improvements to the systems that are used,” Nielsen says. “They must be easy to use, with as little human involvement as possible in the creation and archiving of reports.”

The ultimate goal is a seamless IT system that merges all reports, analysis, data and trends into a single, user-friendly system that can be accessed from anywhere.

“I would rather not spend too much time on maintaining the system,” says Nielsen. “Even when it is provided by a vendor, its actions must be taken care of.

“We are alerted by the vendor about updates to the system in release notifications. The release notifications are risk-assessed and we document the results.

“Sometimes, the updates result in the implementation of new features with subsequent validation and adjustment of procedures to follow.

“System and reporting should be interactive for transferring data, making sure that it’s updated in the right order and time. It’s not that we don’t think the system is OK, but it would be easier if data could be transferred with the press of a button, and with less human interaction.”

The cold chain itself is another seemingly simple idea that can be complicated, and these ideas may need revisiting if pharma companies want to continue relying upon it.

A precise balance must be struck between risk and the cost of issues like controlled room temperature clinical trial shipments.
Developing stability data upfront before trials begin is necessary, as all products are affected by temperature and humidity.


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