Devices & Diagnostics, Pharma, Startups

Janssen regulatory director on CROs: “They’ll screw you in a heartbeat”

Some candor from the director of global regulatory affairs at Janssen Research & Development, as she touched on […]

Some candor from the director of global regulatory affairs at Janssen Research & Development, as she touched on contracting with CROs:

“They’ll screw you in a heartbeat.”

Clinical research organizations are a fine option (and sometimes the only one) for small life sciences companies attempting to push their product through the regulatory pipeline – but often it’s a matter of bait and switch, Kathleen Gibbon said today to an audience of early stage life sciences companies at JLabs San Diego.

“What I do know: CROs will do the whole song and dance and try to say how great and wonderful they are, and give you high level people when they’re in the business development stage,” Gibbon said. “But soon as you start the project, they’ll give you the more junior people. Don’t let them do it.”

Tighten up those CRO contracts early on, Gibbon said. Also, when early stage companies choose CROs, tox houses, manufacturing sites and contract labs, Gibbon suggests that startups be diligent to review warning letters – they’re available on the internet. Furthermore, ask for Establishment Inspection Reports and all follow-up correspondence. Just because a CRO or other contractor has never had a warning letter, doesn’t mean they’ve never had problems, Gibbon said.

“Ask them for those things, and then audit them,” Gibbon said. “And then assign internal personnel who are responsible for oversight of this. Don’t just think you can outsource that stuff – you’ll regret it later.”

[Image courtesy of Flickr user Juan Ramón Martos]

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