Editor's Note: The last sentence in the 11th paragraph has been edited for clarity.

Contributed Commentary By Tom Harris and Kate Godwin-Smith

March 13, 2019 | Brexit has, and will continue to have, a profound impact on clinical trials in the UK and throughout Europe. While no one can know precisely what that long-term impact will be, pharma companies must be ready to adjust quickly.

Many sponsors might have teams dedicated to a post-Brexit clinical landscape—and might have already formulated a plan—but much is still unknown as we enter into new, unchartered territory. For many sponsors, this scenario will be especially relevant for inventory registered within an IRT system manufactured and packaged outside the UK, with the need to be imported in-country. We must always remember that at the end of every potential change, there is a patient who needs to get their drug on time.

Let’s look at one of most vitals area of concern: drug depots.

Individual trial teams might be thinking about moving their physical drug from a UK depot to a new location amid Brexit, but they also need to consider the digital aspects of the move. Whether a client stores its central depot in the UK or transports, an eClinical technology provider should work closely with sponsors to ensure that logistics will run accordingly and on time. 

Any sponsor with a central location in the UK will likely feel an impact. Many sponsors are considering their options amid the current uncertainty of drug shipments leaving the UK. During this timeframe, sponsors should consider the benefits of using a flexible, adaptable IRT system as a part of their trial supply management strategy. For clients who want to keep depots in the UK, it is possible to increase the forecasting period or change the site group to have higher contingency stocks at sites outside the UK, being supplied by a UK depot. As such, having the ability to apply swift updates to the IRT supply configuration is essential. An eClinical provider can help sponsors work through anticipated increased customs and logistical issues they may potentially experience after March 29. This practice will ensure sufficient time and supply chain planning for drugs to reach patients.

If a sponsor decides to move its depots out of the UK—or introduces a new depot facility in addition to the UK—they should consider not only the customs and logistical issues, but also the coordinated update to the drug’s digital location. Moreover, they must consider the digital logistic settings for all sites previously supplied by the UK depot. For a larger trial, this can mean moving thousands of kits and updating a significant number of site settings. A new depot may entail different site delivery lead times. Sponsors need help from eClinical technology providers to plan for this, to set up a new depot outside the UK, dependent upon the client’s timeline, while making the process seamless and invisible.

EBPs and the Reliance on CMOs

While many mid-size to large pharmas have focused, dedicated teams evaluating the potential effects of Brexit, many emerging biopharmas (EBPs) may not be fully equipped. Most EBPs focus their resources on getting compounds through development and rely on Contract Manufacturing Organizations (CMOs). Additional challenges can arise because so many CMOs depend on connections for packaging, supplies, and raw materials. If an EBP outsources a set of responsibilities to a CMO post-Brexit, the CMO could struggle for a variety of reasons. For example, customs delays in obtaining IMP (investigational medicinal product), and excipients can have a negative impact on timelines. Looking down the chain, each and every spoke of that wheel will probably be affected.

There will be many other considerations when Brexit flips the clinical research status quo on its head, including 

• Supply Chain Risks: The anticipated longer shipment lead times post-Brexit could also increase supply chain risks in several areas. Inventory stockpiled in locations to mitigate risk may result in slower turnaround for inventory shipment—both in and outside the UK. The increased risk of a temperature excursion is another lingering possibility. Sponsors might want to change shipper configuration to mitigate this situation. Triggering shipments earlier will help alleviate longer lead times, and even allow for reshipment if the first shipment did have an excursion. Stocking up sites pre-Brexit can be another beneficial option to ensure no shipment is needed immediately after Brexit, when uncertainty is highest. Marking IMP as quarantined due to an excursion will continue to be available to a sponsor in the Cenduit system post-Brexit.

• Subject Matter Expert and Support Resources: In the UK, we rely on frictionless travel, and many life science professionals come here to continue their work. Now, there is a great deal of uncertainty because of potential changes in residential status.

Two things we know for certain: Changes are coming, and proactivity is key. eClinical solutions providers must be flexible and agile enough to adapt, as well as to respond expediently to these coming changes. They must ensure that their clients continue to feel like it is business as usual. When a client needs to make any change to our IRT system, we continue to follow standard operating procedures and processes, with checks and balances to ensure that all changes are made accurately, and to the client's requirements.

Tom Harris is Project Manager; and Kate Godwin-Smith, Associate Director of Project Management, at Cenduit LLC’s UK operation. They can be reached at tom.harris@cenduit.com and kate.godwin-smith@cenduit.com.