Compliance Today (March 2021)

According to a recent U.S. Department of Justice news release, Yvelice Villaman Bencosme, a Miami, Florida, doctor and the primary investigator for clinical trials designed to investigate the safety and efficacy of a children’s asthma medication, has acknowledged that she fabricated data and faked medical records “to make it appear that pediatric subjects arrived for scheduled visits at Unlimited Medical, took study drugs as required, and received checks as payment for site visits.”^[1]

According to the news release, “Bencosme faces a maximum penalty of 20 years in prison. Bencosme is the second defendant to plead guilty in this matter. Lisett Raventos, a former study coordinator at Unlimited Medical, pleaded guilty to a conspiracy charge in November 2020. Two other defendants were charged in connection with the scheme, and they are presumed innocent until proven guilty beyond a reasonable doubt.”

1 U.S. Department of Justice, “Florida Medical Doctor Pleads Guilty to Conspiring to Falsify Clinical Trial Data,” news release, January 8, 2021, http://bit.ly/2LTxIJo.

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