FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

Build Quality Milestones into Device Trial Sites, Auditor Urges

Nov. 1, 2018

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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