When a patient, site or study team member has an issue or question in your clinical trials, do they know who to call?…
Brexit, the process of the UK leaving the European Union (EU), is creating uncertainties across many industries. Early indications from the European Medicines Agency (EMA) are that it will have a significant impact on the pharmaceutical and biopharmaceutical industry globally.
One area at risk of disruption is the supply chain for investigational medicinal products (IMPs).
The EU requires the ‘gateway’ for a Qualified Person (QP) release and distribution of investigational product to be sited in a member country. If a clinical trial sponsor or their contract manufacturing / logistics provider is using the UK as that gateway, then that currently approved supply route is at risk. This applies to all global pharmaceutical companies executing studies with sites in EU countries.
While many details are still unresolved at this point, the EMA has provided guidance to give marketing authorization holders of centrally authorized medicinal products some initial direction. According to guidelines issued jointly by the EMA and the European Commission, the UK will become a “third country” beginning March 30, 2019. Although this guidance for commercial drug releases, it is a strong indicator of what will be applied to IMPs. The implication of the guidance is that if your QP release and clinical trial distribution to sites in EU countries is currently located in the UK, you are likely to have to relocate it to a remaining EU member country.
Although there are uncertainties, we do know enough to assess potential risks to the clinical trial supply chain and take actions to mitigate them. My advice is don’t wait, the clock is counting down fast towards March 2019, and the risks are compounded by many QPs being located in UK based facilities today, which could lead to competition for those scarce resources.
You can start by using the simple flowchart below to determine the likely impact on your studies.
To monitor temperatures during shipping, nearly all temperature-sensitive shipments include a validated temperature logger. Such loggers are activated manually at point A, deactivated, read and reactivated at point B, and so on from location to location until they reach the investigational site. Data or PDF downloads collected from those loggers are often entered manually into a spreadsheet or database and then they are sent via e-mail to the sponsor to facilitate manual drug release procedures to the investigational site.
Typically, data are not collected or reported in real time. Therefore, products can be out of their temperature window for a considerable time before it’s detected. Resupplying material can be costly and cause delays in getting drug to sites and patients. It’s also difficult to get an aggregated view of temperature data throughout the entire ‘supply chain of custody’ – from the manufacturer to the patient.
PAREXEL’s Clinical Trial Supplies and Logistics team have over 10 years’ experience of managing global distribution of IMP. We are available to further advise on your Brexit risk mitigation strategy and to provide IMP release from our European Distribution Center in Berlin. Please contact me at Tony.Street@PAREXEL.com to discuss your situation and how we can help.
Whether you refer to the functions as RTSM – Randomization and Trial Supply Management, or to the underlying…