The two defendants are Miguel Angel Montalvo Villa, 53, the CEO and co-owner of AMB Research Center, and Ivette Maria Portela Martinez, 53, a pharmacist and data entry specialist at the clinic. From 2015 to 2018, the two enrolled patients without their consent into a clinical trial for an experimental drug for Clostridium difficile-associated diarrhea.
The patients did not have CDAD, but Mr. Montalvo and Ms. Portela falsified hundreds of documents into clinical trial databases, according to the Justice Department.
Their sentencing is scheduled for Nov. 30.
