Seven Deadly Sins of Trial Supply Management: Time To Chill Out? Think Again.

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By Alan Morton

Trial Supply Manager

Supply chain logistics can make or break a clinical trial. In many cases, failure to provide and manage trial supplies on time has resulted in costly delays. So how does a CRO partner work with a sponsor to ensure supplies are properly managed?

Over the next few weeks, stay tuned to PSI On Point to learn about “seven deadly sins” of trial supply management, brought to you by PSI Trial Supply Manager, Alan Morton.

Last week, we looked at the deadly sin of greed and penny pinching and walked through the dangers of being too money-focused. This week, we’re diving back in and looking at our fourth warning sign… being the dreaded sloth – lazy.

Sloth (Chill Out…Nothing Will Go Wrong!)

Failing to plan adequately or on time.

People tend to stick to their area of expertise and focus their attention on making the arrangements for what they understand. This often means that areas such as IMPD collation, Protocol Writing, CTA Submissions and Site Selection area all arranged in good time and the drug purchase and distribution arrangements can be left until later. Unfortunately, it can take over 6 months to arrange for the purchase and packaging of the supplies, arrange the distribution aspects and Import License applications, and then ship to a country. This means that although a study is otherwise ready to go, the drug supplies are not ready, so start-up is delayed until these aspects are taken care of.

Failure To Plan? Planning To Fail.

In-depth planning is vital to make sure that the strategies for production and distribution of the supplies are robust and appropriate to the type of drug that is being provided. Knowing the lead-times for each of the component parts and re-supply timelines when the study is in progress is vital to allow scheduling of additional packaging campaigns to be done at the right time. Too early, and we waste shelf-life of supplies, meaning that we might need to pack extra. Too late, and we can’t supply the patients that need it.

As an example – if a patient is on treatment for 1 year and visits the hospital every 3 months to collect medication, we need to have new supplies on the shelf at the hospital that have an expiry date of at least 3 months after their visit to allow the patient to be dispensed their treatment. Add to this the lead time to get the supplies to a local depot (planning timelines always works on the longest lead time – for the Philippines it can take 90+ days to arrange the shipment) then add on the production time, which can take another 3 months, and you may need to start planning re-supply campaigns a year or more prior to the expiry date of the supplies! This is made more complicated when supplies have a short shelf-life, or when countries, such as India or China insist upon a set amount of residual shelf-life available when they are imported.

Planning – Put Patients First.

So what does all of this mean? When planning a trial, you cannot just “chill out.” There’s no time to fall into the deadly sin of being a sloth because it’s quite possible that something will go wrong if you let time pass without planning appropriately.

Be sure to calculate your timelines accordingly, and work together with sponsors and vendors to ensure a smooth process for drug supply and drug management. After all, the patient is counting on your ability to manage these logistics, and all others, without any error.

Next In The Series:

Stay tuned for the next deadly sin to avoid, and find out how a CRO can partner with vendors on behalf of sponsors to ensure trial supplies aren’t just an aspect of the project, but a successful arm of the product. Hint: next week, we’re calming down and maintaining relationships…kindness is key…

Alan Morton, Trial Supply Manager

Alan has been working in the logistics and supply chain arena for almost 30 years and has spent the last 7 working for market-leading drug supply and packaging vendors supporting studies all over the world.