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 the PSI Newsroom to learn about The Seven Deadly Sins of Trial Supply Management, brought to you by PSI expert and supply chain aficionado, Alan Morton.
Our first warning sign? Lust.
Lust (That vendor is the market leader, we want to use them)
Being seduced into using an inappropriate vendor. Vendors will all claim to be able to complete all services better than all the rest.
Being tied to a particular vendor limits the ability to objectively choose the best one for the job. Ensuring that the selection is made on quantitative and unbiased data will help – we’ve all heard horror stories about ‘This packaging vendor doing…’ or ‘That IWRS system is rubbish – don’t use them’.
A couple of recent studies chose a well-known IXRS provider. The reasons for the choice are clear – they are a big, well-known company; they were doing the eCOA, so had easy integration; their sales pitch was very slick, and they were promising cheaper and quicker set-ups than the others that could have been used. The studies were reasonably complicated – one was a triple blind study using a biosimilar product and the other was a double-blind double-dummy study using a combination of IV and tablets, both with matching placebo and dispensed at different times throughout the patient’s treatment schedule.
Because of these complications, the automatic shipment generator did not work properly, meaning that PSI had to provide and fund an additional resource to manually trigger each shipment from within the system. As well as the resource issues, there was also the added risk that the person triggering the shipment could make a mistake, leading to an increased chance that a patient could be left without treatment.
Make the Right Choice the First Time
It is very difficult to change vendors mid-way through a study, so assessing the ability of a vendor and being critical of their abilities is vital to ensuring that the best and most appropriate decision is made. How do you fancy having to tell your senior management that the vendor that you suggested is not able to deliver and we need to pay to change to another one?
Having proper oversight and working from solid metrics and KPIs helps ensure that a decision to use a particular vendor is not made on reputation or hearsay. Water-cooler stories about vendors making mistakes can tarnish their reputations unfairly, so while the selected vendor may not be suitable for complicated studies, their quick setup times still make them a good choice for more straightforward ones.
PSI doesn’t have preferred suppliers. We have a number of approved vendors that we have carefully selected and audited prior to using them on our studies. We work in partnership with them and see their performance as an extension of our own, so just as we pick Project Managers according to their strength and knowledge of an indication, we ensure that the vendor that we recommend for a study is able to cope with the work that we are allocating to them.
Chasing after one vendor with the expectation that they will serve every project in the same manner is the first in our series of deadly sins in trial management. Don’t fall into lusting over a certain vendor, but rather ensure that every vendor is the right match for the specific study.
Stay tuned for the next deadly sin to avoid, and learn about 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.
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.