CRO own­er pleads guilty to ob­struct­ing FDA in­ves­ti­ga­tion in­to fal­si­fied clin­i­cal tri­al da­ta

The co-own­er of a Flori­da-based clin­i­cal re­search site plead­ed guilty to ly­ing to an FDA in­ves­ti­ga­tor dur­ing a 2017 in­spec­tion, re­veal­ing that she false­ly por­trayed part of a Glax­o­SmithK­line pe­di­atric asth­ma study as le­git­i­mate, when in fact she knew that cer­tain da­ta had been fal­si­fied, the De­part­ment of Jus­tice said Wednes­day.

Three oth­er em­ploy­ees — Yvelice Vil­la­man Ben­cosme, Lisett Raven­tos and May­tee Lle­do — pre­vi­ous­ly plead­ed guilty and were sen­tenced in con­nec­tion with fal­si­fy­ing da­ta as­so­ci­at­ed with the tri­al at the CRO Un­lim­it­ed Med­ical Re­search.

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