The News No Sponsor Ever Wants To Receive

When pharmaceutical companies hire a contract research organization (CRO) to manage their clinical trials, they may assume that the trial management includes detailed oversight of data collection and analysis. It does most of the time, but ultimately, the responsibility for data governance remains with the sponsor.

This lesson was brought home to many sponsors on September 16, 2021, when the Federal Drug Administration (FDA) issued a stark warning: Clinical or bioanalytical studies conducted by two specific CROs were deemed unacceptable. As a result, all studies—approved, tentatively approved, or currently under review—managed by either CRO were effectively rendered invalid and would need to be repeated.

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