With Brexit scheduled to occur on 2019年3月29日, the pharmaceutical industry is quickly bracing for its impact. After the United Kingdom (UK) decided to pursue Brexit following the 2016年6月23日 referendum, there has been a lot of uncertainty surrounding the clinical supply chain and its operations.
Ensuring drugs are available to patients in clinical trials is of the utmost importance for pharmaceutical and biotech companies, large and small. With IRT playing an important role in the management of drugs at depots and sites around the globe, Drug Supply Managers have expressed worry about Brexit’s impact to their IRT system.
Brexit: The only thing certain is uncertainty
A main reason for concern is a lack of clarity from the UK and European Union (EU) governments about what exactly Brexit will entail. While the UK’s prime minister, Theresa May, and the EU’s governing body are still discussing the details of an agreement between their two parties, there is also the potential that they will not agree on one and proceed without any guidelines forward (known as a “no-deal Brexit”). Moreover, some parties within the UK’s government are trying to prolong, or even reverse, Brexit entirely before the March 29 deadline.
Whatever happens, one thing is certain: There is bound to be a lot of instability in the UK’s relationship with EU member countries. This obscurity from the government has left supply chain managers scrambling, making the complexity of clinical trials and drug supply even more complex.
How will Brexit affect clinical trials?
Global clinical trials often require drug to be shipped from depots in one country to depots or sites in another country. The UK has historically been a hub for clinical supplies facilities, and depots located there have been used to ship drug to both the UK and the EU at large.
With currency and customs being a major concern post-Brexit, The European Medicines Agency (EMA) published a Q&A about the impacts of the UK withdrawal that answers some of the pressing regulatory issues that might be faced.
With such uncertainty in trade relations between the UK and EU countries, many sponsors will be using new depots in EU member countries, such as Ireland and Germany, shipping drug to these new depots, and setting them up to supply the EU sites in their studies.
As Brexit’s date in March quickly approaches, it’s important for sponsors to identify and implement these changes as soon as possible.
How can Suvoda IRT help minimize Brexit’s impact on your trial?
When figuring out how to deal with Brexit’s impact on your global trial, the last thing you need is for your IRT system to be another problem to solve. At Suvoda, we understand that clinical trials can be unpredictable, and that some things – like global politics! – are out of your control.
Some IRT vendors require depots to be determined at the start of the trial in order to be hard-coded into the system prior to study startup. Change orders are required when new depots need to be added, which can take time and cost money.
Suvoda’s system is different.
No Costly Change Orders Needed
Our depot management interface is purposefully designed to let you manage your trial flexibly, by adding, deleting, and editing depots in real time, at any time. From study startup to archival, you will always have full control over the depots and sites in your IRT system.
With Suvoda, switching a site from being supplied by one depot to another can be done in less than 5 minutes. As a sponsor user, all you have to do is input the new depot’s information, define what countries that depot should supply, and save. From that point forward, any sites previously supplied by the UK depot will start requesting shipments from the newly added depots (from Ireland, for example).
Our user-friendly drug ordering interface also allows you to quickly and easily create shipments between depots, so you can move supplies out of the UK to anywhere they are needed.
In less than half an hour, your IRT system will be ready for Brexit – no change orders required!
Navigating the Unexpected – Brexit or No Brexit
At Suvoda, we are passionate about the progress of your clinical trials. Even in the midst of global political uncertainty, our goal is to help minimize delays, simplify complexities, and ultimately give you peace of mind to focus on your patients.
The most important thing your IRT system can do is help you navigate the unexpected, so that no matter what decision is ultimately made by the UK government, your clinical trials will continue to run without time-intensive and costly delays in your supply chain.
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