VENDOR SELECTION
impact my projects, and that’s not something we want.
Can you think of any examples where you worked with a vendor and managed to align? Something I’ve seen is the paperwork – there’s no point in using your own forms when you know the vendor has its own documentation that works well, whether it’s for distributions, returns or reconciliations, so it could be disrupted if they’re not used to your paperwork.
Do you think this is a major challenge for Big Pharma? It may be harder for Big Pharma because they have more formalised processes. What I know from my previous experience as a vendor (I used to work on the other side of pharma supplies for something like 10 years) is that some Big Pharmas tend to impose or use their forms. At some point, it’s OK, and they have their own requirements in such a way that they can process quickly for every vendor to understand. After a while, you get used to their form, but it’s a learning curve, and the initial phase is prone to a misunderstanding of documents that could lead to errors.
What kind of improvements would you like to see in the industry?
Where there is some room for improvement in the industry is related to the labelling of supplies. There’s is no standard yet. The phrases are standardised to some extent, but the layouts and coding or the labels are not, and I understand that for sites trying to work with many different sponsors, it can be a challenge.
Some sites apply their own labels to clinical
“It’s OK that we’re different companies and have different goals. We just ‘get married’ for a project and know that this work in common should be fulfilling for both parties. So we get a supplier that provides activities we’re not able to provide for ourselves, and they get revenue.”
22 | Clinical Trial Supply Handbook
supplies just to overcome the challenges, so labels don’t fit the format of their organisation as they would expect them to work in their own organisation. Standardisation of coding may remove the need for sites to apply their own clinical labels. But that would require that sites harmonise between themselves. The use of multiple systems – for instance,
interactive response technology (IRTs) – also creates challenges at clinical sites. IRTs tend to be more flexible and integrated with the distribution networks, but I still see lots of struggles at the user’s end site.
Do trial sponsors and vendors struggle with labelling? I don’t think our vendors struggle with labels because they’re developed in common; we develop our clinical labels together with the vendors. There are some funny cases, though, such as where we had labels printed in red just to distinguish those from escalation studies. During my previous experience as a packaging manager for a vendor, one label was unfortunately printed with red ink, and the barcode readers did struggle to read the barcode, but that’s something that was unexpected and does not happen too often. The label was developed between the vendor and the sponsor, and everything was fine, until they realised it didn’t scan, so they had to scan it under a special light. It wasn’t a deal-breaker, but they had to take some care that the blinds were closed.
What are some key trends in the industry that pique your interest? The past few months have been filled with challenges with DtP (direct to patient) deliveries. There has been disruption with clinical studies where patients were not able to come to sites, so there were contingency plans, and the regulatory agencies’ position was softened, because something like DtP – which would have been a no-go in Germany two years ago – has come a long way. In our company, our pipeline is more towards cold chain, and even with this new supply chain model, we didn’t have issues with temperature, drug accountability – that was still well-managed. I think that opens doors for the future because the pharma industry has proven that it is able to manage patient deliveries and remain compliant from a product quality, patient confidentiality and medical oversight point of view.
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