The co-owner and pharmacist of AMB Research Center, a Miami, Fla., site, have both been convicted by a jury over a plot to falsify and fabricate clinical trial data for profit, the Department of Justice (DOJ) announced.

Miguel Angel Montalvo Villa, co-owner, president and CEO, and Ivette Maria Portela Martinez, pharmacist and data entry specialist, were both convicted on single counts of wire fraud and conspiracy to commit wire fraud, the DOJ said. Villa, who also served as the site’s lead study coordinator, was additionally convicted of giving a false statement to an FDA investigator during a February 2018 inspection. Sentencing is slated for Nov. 30.

According to the evidence, Villa and Martinez falsely listed the names of individuals as participants in a Clostridium difficile-associated diarrhea (CDAD) drug trial and concocted fake data for these made-up patients, the DOJ said. “[They] falsified hundreds of pages of documents and entered that false information into clinical trial databases to make it appear as though the purported subjects had CDAD and were fully participating in the clinical trial, when in fact they were not.”

Montalvo additionally told an FDA investigator during inspection that informed consent was gathered from all of the fake participants.

False invoices filed as part of the trial data conspiracy totaled nearly $278,000.

In addition to Villa and Martinez, Bernardo Garmendia, site co-owner and study coordinator, was charged with counts of wire fraud last year (CenterWatch Weekly, Oct. 17, 2022) but has not been convicted as of publication.