FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Build Quality Milestones into Device Trial Sites, Auditor Urges

Nov. 1, 2018
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Sponsors of device trials should build quality milestones into site contracts as an insurance against FDA inspections, a veteran auditor told the MAGI clinical research conference in San Diego last week.

Fran Ross, a senior consultant of CGI, says that it can be all too easy to lose control over a trial, especially when using contract research organizations (CROs), so sponsors should “start with the contract” and build in a payment schedule that revolves around quality deadlines — such as the first visit of a first patient.

One device sponsor received a Form 483 with 32 pages worth of errors, most of them chalked up to the CRO’s malpractice, she said. It took more than a year and a half to audit all 60 sites in the trial and it cost the sponsor more than $1.5 million in audit fees.

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