At Partnerships in Clinical Trials in Orlando Human Genome Sciences (HGS) and other small to mid-sized biopharma outlined their reasons for working with large CROs (contract research organisations). HGS said their old transactional model was “very, very inefficient” and this prompted a reevaluation.
Before choosing two large CROs to work with HGS assessed how they could guarantee a good service. “We have a relatively large portfolio that can give the CROs significant backlog over a seven year period”, Ann Wang, vice president, clinical operations and data management at HGS, said.
HGS should give enough backlog to the two CROs to get their attention, Wang said, but if its partners are more focused on big strategic clients it will walk away early. “We don't want to be in a marriage that falls apart in four years because that will be disruptive”, Wang said.
While partnering with a few large CROs creates these problems Wang said the model is more manageable than a bigger network of niche providers. “We felt we lacked the resources to manage multiple CROs in a 'best in breed' approach”, Wang said.
Grabbing attention
At the moment HGS is talking to its CROs about safeguards to stop attention-deficit problems arising. Key performance indicators (KPIs) are one area of focus and HGS is also discussing how it can grow people within its CRO partners as the projects progress.
Success of these talks is based, in part, on transparency and trust. Graeme Currie, head of clinical project management and operations at Regeneron Pharmaceuticals, has moved from transactional outsourcing to channeling lots of work to one large CRO partner. The CRO is involved in big deals.
Currie said Regeneron has spoken very directly with its CRO partner about the potential to be overlooked in favour of bigger strategic clients. Despite this direct approach Regeneron has still met communication problems.
“I think one of the challenges we face is the transparency of discussion between the two sides. We are not getting the transparency we would ideally like”, Currie said. Regeneron is looking to add a second CRO partner.
Setting parameters
Sponsors can word contracts to mitigate risks of working with a large CRO, such as a clause to make it pay for training after a certain level of turnover, but these can discourage the vendor. There are limits to contracts too. “You can't have complete control but you can put in parameters”, Currie said.
Even with contractual obligations and parameters though a partnership requires a degree of faith. “Being able to completely trust in the partner is the hardest step to take”, Anne Harcarik, director of clinical operations at CR Bard , said.