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.
The 14-page indictment alleged that Palacio “falsified the participation of subjects in the Study” to increase payments from the organization that contracted with Unlimited Medical to conduct the study. Specific actions included enrolling study particpants that Palacio and co-conspiratiors knew to not meet study criteria, enrolling of pediatric patients from a co-conspirator’s medical practice without their consent, and discarding the study drug without using it.
The specific charges against Palacio include conspiracy to commit wire fraud and false statements. Other conspirators are identified in the indictment, but only Palacio was charged, and other conspirators were not mentioned in the DOJ press release.