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# Three Charged with Falsifying Clinical Trial Data
- URL: https://www.fdaweb.com/three-charged-with-falsifying-clinical-trial-data/
- Published: 2022-10-13T12:00:00.000Z
- Updated: 2026-09-14T18:03:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152970

A Miami grand jury has charged three defendants for their roles in an alleged scheme to fabricate and falsify clinical drug trial data submitted to FDA, according to a Department of Justice [release](https://www.justice.gov/opa/pr/florida-medical-clinic-owners-and-staff-charged-falsifying-clinical-trial-data?ref=fdaweb.com). The just-unsealed indictment has charged **Miguel Montalvo**, **Bernardo Garmendia**, and **Ivette Portel**a, all of Miami, with conspiracy to commit wire fraud and one substantive count of wire fraud, DoJ says. In addition, Montalvo was also charged with making a false statement to an FDA investigator.

According to the indictment, from 9/2015 through at least 3/2018, the three individuals fabricated clinical trial data for profit while working at AMB Research Center, a medical clinic based in Miami. It alleges that the defendants “knowingly enrolled subjects in a clinical trial even though those subjects failed to meet eligibility criteria, falsified subject laboratory results, falsified subject medical records, and falsely represented that subjects were taking the drug being studied when, in fact, they were not,” DoJ says. “Montalvo and Garmendia were co-owners of AMB Research Center, where Montalvo also served as a lead study coordinator and Garmendia served as a study coordinator. Portela worked at AMB Research Center and was a pharmacy technician.”