Clinical Trials Arena: What are some of the difficulties you face in your line of work?
Industry Expert: Within this space there are numerous challenges that I face, but chief among them are cold chain management, temperature maintenance and frozen distribution. When it comes to cold chain management in particular, it’s crucial to have a strong infrastructure in place ensuring your product arrives in the appropriate condition to wherever it is needed before distributing it on a global scale. Additionally, vendor responsiveness is often not what we expect and that is a major problem.
CTA: In what way exactly?
IE: So the turnaround time, for example, is longer than expected and even longer than agreed. When you set up a contract with a vendor, for instance, regarding ancillary supply, although we normally send the ancillaries to the depot, we instruct the sites to directly contact the depot. Therefore, we are not in the loop for these requests.
Just recently, I received an alert that was sent out four weeks ago without any response from the depot. This is something where we’d normally expect a response within five to 10 days. This means when after the request has been sent from the site, the depot should have sent out the ancillaries within five to 10 days at the maximum.
CTA: Cold chain management is an area you previously mentioned, and it’s an aspect routinely mentioned among CTS experts. What specific challenges do you face in that regard and how do you go about mitigating them?
IE: What we see are a lot of delays getting medications through customs, so we try to make sure all our documents are up to date. To counter that, we are constantly trying to improve our capabilities, improve the shippers that we use, the couriers we use, while continuously evaluating our active specific cooling systems.
CTA: Is it difficult navigating past different regulatory barriers when you’re shipping supplies abroad through customs and border control?
IE: It can be, absolutely. Each country has different rules and regulations and that of course has to be complied with. For the most part, Europe is harmonized, and moving products from country to country is straightforward, with the odd exception. But other than that, there is free trade of goods and investigational products fall under that remit.
CTA: So when you speak of delays, are you referring to outside of Europe?
IE: Yes. We distribute products globally and at times we can encounter various issues. For example, when there’s a delay or a roadblock, we get in touch with our contact on the other end and make sure the paperwork they may request is updated to their standards. But herein lies the challenge – you always have to customize that. In future, I’d like to see customs processes become more harmonized globally. If there is one uniform process that clarifies this is the way it should be prepared that would be beneficial for all parties involved. If your investigational product is accompanied by the correct documents then it will get through customs.
CTA: How do you guard against these circumstances?
IE: It depends. Normally we directly contact the vendor, asking for reasons why this happened as there are KPIs established in the contract. In this example, we’re thinking about carrying our inspections at the vendor because this has a great impact on our sites. We want to be a reliable partner in clinical trials and this includes the vendors.
CTA: What are some of the best practices people should take onboard when managing vendors?
IE: In my experience, I've seen differences in approaches from clinical vendors and clinical supply vendors. Normally I would expect that they are the best ways to increase the qualities more or less to do this more or less how the clinical CROs are managed. For example, in initial face to face meetings establish KPIs, while creating a communications plan identify and some documents starting with the communications plan that describes how the processes would work, then to stick with what has been agreed. It’s vitally important this is adhered to.