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Study Coordinator Charged in Scheme to Falsify Clinical Trial Data


Study Coordinator Charged in Scheme to Falsify Clinical Trial Data
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Written by Justice Department
Miami, Florida - A federal grand jury in Miami, Florida, returned an indictment Tuesday charging a Florida woman with conspiring to falsify clinical trial data regarding an asthma medication. 
According to court documents, Jessica Palacio, 34, of Miami, worked as a study coordinator at a clinical trial firm in Miami called Unlimited Medical Research. Unlimited Medical Research was one of many companies hired to conduct a clinical trial designed to investigate the safety and efficacy of an asthma medication in children. The indictment alleges that Palacio participated in a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs as required, when in fact these things had not occurred. ....

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Grand Jury Indicts Clinical Trial Study Coordinator for Falsifying Asthma Medication Data


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The Department of Justice announced Tuesday that a Miami grand jury returned an indictment against Jessica Palacio, a study coordinator at Unlimited Medical Research, a firm that provides clinical trial services for medication.
According to the DOJ press release, “[t]he indictment alleges that Palacio participated in a scheme to falsify medical records to make it appear as though pediatric subjects made scheduled visits to Unlimited Medical Research, received physical exams from a clinical investigator, and took study drugs as required, when in fact these things had not occurred.” The indictment also alleges that Palacio lied to an investigator with the Food and Drug Administration when asked about her conduct. ....

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Florida Doctor Pleads Guilty to Faking Clinical Trial Data


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A Florida doctor has pleaded guilty to falsifying clinical trial data for an asthma medication that was being studied in young children, the U.S. Department of Justice announced.
Yvelice Villaman-Bencosme, MD, admitted that, from 2013 to 2016, she participated in a scheme to defraud the pharmaceutical company behind the drug by fabricating data and participation in the clinical trial. The trial, conducted at Unlimited Medical Research in Miami, was meant to study the safety and efficacy of an asthma medication in children ages 4 to 11.
Villaman-Bencosme, who served as the primary investigator for clinical trials at Unlimited Medical Research, admitted that she falsified medical records to make it appear pediatric patients had arrived for scheduled visits, taken the study drugs as required, and received checks as payment for visits. ....

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Miami Doctor Falsified Clinical Trial Data For Asthma Meds: DOJ


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Dr. Yvelice Villaman Bencosme of Miami falsified clinical trial data for a children’s asthma medication, the DOJ said. (Shutterstock)
MIAMI, FL A Miami doctor pleaded guilty to falsifying clinical trial data for a children s asthma medication and committing wire fraud Friday, the Department of Justice said in a news release.
Dr. Yvelice Villaman Bencosme, 64, served as the primary investigator for clinical trials purportedly conducted at a medical clinic called Unlimited Medical Research in Miami.
In pleading guilty, she admitted that between 2013 to 2016 she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating the data and participation of subjects in a clinical trial at Unlimited Medical, the DOJ said. ....

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