Trial sponsors say CROs need to own their mistakes and take responsibility –

Trail sponsors have said that they want contract research organisations (CRO) to take more responsibility and own their mistakes when the service they provide falls short.

That was the key theme of a panel discussion at the ongoing 11th Annual Clinical Trial Supply Nordics conference in Copenhagen. 

The panel discussion included executives from biotech and pharma companies with different areas of expertise sharing their experiences and what they wanted to see from CROs.

Principal data manager for the biotech Zealand Pharma, Ane Jensen said, “What I realised when I moved from a big pharma firm where a lot of things were done in-house, to a fully outsourced setting, I had a realisation that if certain trials fail, we could potentially stop existing. But the CRO could go on. So, my focus is to work with one that is very accountable and very knowledgeable.

“I want them to take us seriously because this is a very serious business to us.”

The panelists went into detail about the nature of the traditional CRO and how a multitude of sites and hierarchies has often led to different departments of the same CRO blaming each other when a clinical trial falls short of its deadlines. Among different solutions, the panelists broached the topic of placing penalties on CROs who fail to meet deadlines, but also noted that doing this could make a CRO far less inclined to work with a sponsor, as well as adding further negotiations to the process.

Titled ‘Reversing the conversation – what the clinical trial industry really wants from its service providers,’ the panel also dove into how relationships with CROs can break down, and what sponsors need to do to keep CROs on their side.

All the panellists were posed the question “If you are not happy with one of the big, how much flexibility do you have to just not work with them again?”

In response, Swedish biotech Camurus’ clinical programme director, Lisa Hellstrom said: “I know that it can be a bit cumbersome, but we need CROs. We need their expertise. But I understand that they are big organisations who see delays, it’s not possible for small companies to do all the communications with all the sites ourselves.”

The panel also hit upon the benefit of CROs employing site managers who act as a singular point of contact for sponsors, as opposed to numerous managers at various sites, allowing for a much more streamlined process in terms of management.

Jensen added: “What I would like to see is fewer roles but with more responsibility inside of those roles.”

The panel also included the senior corporate counsel for Leo Pharma, Andreas Cederholm and was chaired by senior Clinical Director, Clinical Development at the Swedish company Cantargia AB, Helen Johansen Blanco.

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