Clinical Trial Fraud & Research Misconduct Defense
Former DOJ Fraud Section Prosecutors. Nationwide Defense for Principal Investigators, Contract Research Organizations, Study Coordinators, Pharmaceutical Sponsors, and Clinical Research Professionals Facing Federal Investigations and Prosecutions for Data Falsification, Research Misconduct, FDCA Violations, Wire Fraud, and False Claims.
Based in Washington, D.C., Armstrong & Bradylyons PLLC defends principal investigators, contract research organizations (CROs), study coordinators, sub-investigators, pharmaceutical sponsors, data management professionals, and clinical research executives in federal investigations and prosecutions involving clinical trial data falsification, research misconduct, FDCA violations, and fraud.
Clinical trial fraud is now a top DOJ enforcement priority. DOJ’s Consumer Protection Branch publicly identified clinical trial fraud as a focus of aggressive enforcement. The government has charged at least 16 individuals, including principal investigators and study coordinators, with research fraud crimes in recent years. In March 2025, the co-owners of Florida-based CRO A&R Research Group pleaded guilty in the Southern District of Florida to conspiracy to commit wire fraud for falsifying subject eligibility and clinical data in an asthma drug trial. Three former Magellan Diagnostics executives pleaded guilty in Massachusetts for concealing a malfunction in lead testing devices that produced inaccurately low results. Magellan itself previously entered a deferred prosecution agreement and paid $42 million. In November 2025, DOJ created the Health and Safety Unit (HSU) within the Fraud Section to handle criminal FDCA prosecutions, including clinical trial fraud. The enforcement is accelerating.
The firm’s healthcare fraud defense practice is built on nearly a decade of combined experience at DOJ’s Fraud Section. Scott Armstrong, Drew Bradylyons, and Andrea Savdie tried 17 federal jury trials in healthcare fraud cases at DOJ involving over $2.8 billion in alleged false and fraudulent claims. They understand the intersection of FDA regulatory enforcement and DOJ criminal prosecution that defines clinical trial fraud cases. The government treats data falsification as fraud. The firm defends individuals facing these charges.
Armstrong & Bradylyons PLLC defends every clinical trial fraud matter from the start as if it will proceed to federal criminal prosecution. The sentences in these cases are severe. The financial consequences are devastating. The firm prepares accordingly.
Clinical trial fraud enforcement converges multiple areas the firm already defends. Data falsification triggers wire fraud charges. Fraudulent billing of pharmaceutical sponsors for research that never occurred triggers healthcare fraud charges when federal program funds are involved. Distribution of misbranded or adulterated drugs based on fraudulent trial data triggers FDCA violations. Kickback arrangements between CROs, research sites, and investigators trigger Anti-Kickback Statute charges. Federal grant fraud triggers False Claims Act liability. Scott Armstrong served for nearly a decade at DOJ’s Fraud Section, trying 16 federal jury trials. Drew Bradylyons supervised the Healthcare Fraud Unit’s Miami Strike Force, where several of the major clinical trial fraud prosecutions originated.
Clinical trial fraud enforcement is intensifying across every enforcement channel. DOJ, the FDA, the HHS Office of Research Integrity (ORI), and federal funding agencies are all targeting clinical research fraud through distinct but overlapping enforcement actions.
DOJ Criminal Prosecutions
In March 2025, Angela Baquero and Ricardo Acuna, co-owners of A&R Research Group in Pembroke Pines, Florida, pleaded guilty in the Southern District of Florida to conspiracy to commit wire fraud. They admitted falsifying subject eligibility and clinical data in the trial of an asthma drug. Children who were supposedly enrolled never participated. The pharmaceutical sponsor paid for research that never occurred.
Three former Magellan Diagnostics executives pleaded guilty in the District of Massachusetts in March 2025 for concealing a malfunction in lead testing devices that produced inaccurately low results. Magellan previously pleaded guilty to related misdemeanor FDCA charges and entered a deferred prosecution agreement with a $42 million penalty. The former CEO and COO each pleaded guilty to causing the introduction of misbranded devices into interstate commerce.
At Tellus Clinical Research in Miami, defendants fabricated clinical trial data for trials evaluating treatments for opioid dependency, irritable bowel syndrome, and diabetic nephropathy. Eduardo Navarro received 46 months and $2 million in restitution. Dr. Martin Valdes received 60 months. Multiple study coordinators received 30-month sentences. At Unlimited Medical Research, also in Miami, study coordinator Jessica Palacio was charged in 2025 for falsifying pediatric asthma trial records. Lisett Raventos received 30 months for the same scheme.
The South Florida Epicenter
South Florida has become the epicenter of clinical trial fraud enforcement. The CRO industry is estimated at more than $85 billion. The Miami area alone has been involved in more than 11,000 clinical studies. In July 2025, T3D Therapeutics filed a legal complaint alleging five South Florida clinical trial sites fabricated data in a test of an experimental Alzheimer’s drug. The company described results that were medically impossible. Some placebo-group Alzheimer’s patients were reported as improving. Many participants did not even have Alzheimer’s disease. The $35 million trial was a write-off. Other pharmaceutical sponsors, including Annovis Bio and BioVie, reported similar problems from South Florida sites. These failures are generating both civil litigation and federal criminal referrals.
DOJ Health and Safety Unit
In November 2025, DOJ created the Health and Safety Unit (HSU) within the Criminal Division’s Fraud Section. The HSU assumed responsibility for criminal FDCA prosecutions, including clinical trial fraud. This organizational change signals that DOJ views clinical trial fraud as a standalone enforcement priority requiring dedicated prosecutorial resources. The HSU works alongside the Health Care Fraud Unit and coordinates with the FDA Office of Criminal Investigations.
FDA Regulatory Enforcement
The FDA conducts Bioresearch Monitoring (BIMO) inspections of clinical trial sites, sponsors, and CROs. The FDA issues Form 483 observations documenting violations of Good Clinical Practice (GCP) and 21 C.F.R. Part 312 requirements. Warning letters follow unresolved 483 observations. The FDA can disqualify investigators under 21 C.F.R. § 312.70, barring them from conducting future studies. In severe cases, the FDA refers matters to its Office of Criminal Investigations for criminal prosecution by DOJ. In November 2024, the FDA issued a Warning Letter to a rare disease drug sponsor after a third-party vendor deleted electronic clinical outcome data, demonstrating that sponsors face enforcement exposure for vendor conduct.
ORI and Federal Funding Agency Enforcement
The HHS Office of Research Integrity investigates fabrication, falsification, and plagiarism in research funded by the Public Health Service, including NIH grants. ORI findings can result in debarment from federal funding, retraction of published research, and referral to DOJ for criminal prosecution. The HHS Office of Inspector General investigates fraud involving federal research funding. False Claims Act liability attaches when fraudulent research is funded by federal grants.
Defending Against Charges of Data Falsification and Fabrication
The government charges researchers who fabricate or falsify clinical trial data with wire fraud, conspiracy, and FDCA violations. The firm defends investigators and coordinators by analyzing data management systems, demonstrating protocol compliance, challenging the government’s evidence of intentional falsification, and distinguishing errors from fraud.
Defending Pharmaceutical Sponsors and Contract Research Organizations
Sponsors and CROs face exposure when the government alleges they failed to detect or report site-level fraud, submitted fraudulent data to the FDA, or designed financial incentives that encouraged falsification. The firm defends sponsors and CROs by demonstrating compliance with monitoring obligations, documenting audit and oversight procedures, and challenging theories of corporate criminal liability.
Responding to BIMO Inspections, Form 483s, and Warning Letters
The firm defends clinical trial sites and sponsors responding to FDA BIMO inspections, Form 483 observations, and Warning Letters. The firm develops response strategies to resolve regulatory matters and prevent escalation to investigator disqualification or criminal referral. Experienced counsel significantly improves outcomes at the regulatory stage.
Defending Against Federal Research Grant Fraud and False Claims
Researchers and institutions face False Claims Act liability and criminal fraud charges when the government alleges they submitted fraudulent data in connection with NIH, BARDA, or other federal grants. The firm defends individuals by analyzing grant compliance, challenging the government’s loss calculations, and demonstrating that research was conducted in good faith.
Defense of Principal Investigators
The firm defends principal investigators (PIs) who face criminal charges for data falsification, enrolling ineligible subjects, fabricating informed consent, falsifying medical records, and submitting false data to sponsors or the FDA. PIs face the most severe sentences in clinical trial fraud cases. Dr. Martin Valdes received 60 months at Tellus Clinical Research. The firm defends PIs by retaining independent clinical experts, analyzing trial protocols, and challenging the government’s evidence of intentional fraud.
Defense of Study Coordinators and Sub-Investigators
The firm defends study coordinators, sub-investigators, research nurses, and clinical research associates who face criminal charges for participating in data falsification schemes. Study coordinators face exposure when the government alleges they fabricated patient visits, falsified laboratory results, forged informed consent documents, or created fictitious study subjects. Multiple coordinators received 24 to 30-month federal prison sentences in recent Florida prosecutions.
Defense of Contract Research Organizations
The firm defends CROs and their executives in criminal and civil investigations. CROs face exposure when the government alleges they failed to detect site-level fraud, continued enrolling subjects at sites with known compliance issues, submitted fraudulent data to sponsors, or designed monitoring protocols that were inadequate. The $85 billion CRO industry faces increasing scrutiny as DOJ focuses on the intermediaries that manage clinical trials for pharmaceutical companies.
Defense of Pharmaceutical Sponsors
The firm defends pharmaceutical companies and their executives who face enforcement exposure for submitting fraudulent clinical data to the FDA, marketing drugs based on compromised trial results, failing to report known data integrity issues, or designing financial incentives that encouraged site-level fraud. Sponsors face FDCA charges, False Claims Act liability, and securities fraud exposure when trials are compromised.
Defense of Research Institutions and Academic Medical Centers
The firm defends research institutions, academic medical centers, and university-affiliated clinical trial sites that face federal investigations. Institutions face exposure under theories of institutional knowledge, supervisory failure, and False Claims Act liability for grants obtained based on fraudulent research. ORI findings can result in institutional debarment from federal funding.
Scott Armstrong and Drew Bradylyons built fraud cases at DOJ’s Fraud Section. They understand how regulatory investigations become criminal referrals.
FDA Bioresearch Monitoring (BIMO) Inspections
The FDA conducts routine and for-cause BIMO inspections of clinical trial sites, sponsors, CROs, and institutional review boards (IRBs). Inspectors review source documents, case report forms, informed consent records, and laboratory data. Discrepancies between source documents and reported data trigger Form 483 observations. Unresolved 483 findings escalate to Warning Letters, investigator disqualification under 21 C.F.R. § 312.70, and criminal referrals to DOJ.
Sponsor and CRO Monitoring Audits
Pharmaceutical sponsors and CROs conduct monitoring visits and for-cause audits at clinical trial sites. When monitors identify data integrity issues, they report findings to sponsors, IRBs, and potentially to the FDA. Sponsor-initiated audits have triggered some of the most significant criminal referrals. T3D Therapeutics’ post-trial analysis revealed medically impossible results, leading to a lawsuit and criminal scrutiny of five South Florida sites.
Whistleblower and Employee Complaints
Current and former employees at clinical trial sites, CROs, and pharmaceutical companies report suspected fraud to the FDA, DOJ, and ORI. Qui tam whistleblowers file False Claims Act complaints when they identify fraud involving federally funded research. The May 2025 expansion of DOJ’s Corporate Whistleblower Awards Pilot Program now expressly covers federal health care benefits fraud, including clinical trial fraud.
Data Analytics and Statistical Analysis
The government uses statistical analysis to identify anomalous patterns in clinical trial data. Medically impossible results, uniform data patterns, and statistical outliers trigger investigation. The T3D Therapeutics case was identified when post-trial analysis revealed placebo-group patients supposedly improving from Alzheimer’s disease. The government retains biostatisticians and clinical experts to analyze trial data for fabrication signatures.
Grand Jury Subpoenas and Search Warrants
Federal agents execute search warrants at clinical trial sites, CRO offices, and residences. They seize electronic data, case report forms, source documents, laboratory records, financial records, and communications. Grand jury subpoenas compel production of trial records, employment records, and financial documents. Electronic discovery in clinical trial fraud cases is voluminous and technically complex.
Cooperating Witness Testimony
DOJ secures cooperation from study coordinators, sub-investigators, and site employees who participate in plea agreements and testify against principal investigators, CRO executives, and others. Multiple defendants in the Tellus and Unlimited Medical Research cases cooperated with the government. The firm has extensive experience cross-examining cooperating witnesses at trial.
Wire Fraud (18 U.S.C. § 1343)
Wire fraud is the primary charging statute in clinical trial fraud cases. It carries up to 20 years per count. Every electronic communication, data submission, or payment in furtherance of the fraud scheme supports a separate wire fraud count. The A&R Research Group defendants pleaded guilty to conspiracy to commit wire fraud.
FDCA Violations (21 U.S.C. §§ 331, 333)
Distribution of drugs or devices based on falsified clinical data violates the FDCA. Introducing misbranded or adulterated products into interstate commerce is a misdemeanor (up to one year) or a felony with intent to defraud (up to three years, or 10 years for second offenses). The Magellan Diagnostics executives pleaded guilty to causing the introduction of misbranded devices into interstate commerce.
Conspiracy (18 U.S.C. § 371)
Conspiracy charges are standard in clinical trial fraud cases. They carry up to five years per count. Conspiracy captures every participant in the scheme, from the principal investigator who directed the falsification to the coordinators who executed it.
False Claims Act (31 U.S.C. §§ 3729–3733)
The False Claims Act imposes treble damages and per-claim penalties for submitting false claims to the government. Clinical trial fraud triggers FCA liability when federal grant funds were obtained based on fraudulent research, when drugs approved based on falsified data are billed to Medicare or Medicaid, or when federally funded institutions submit false progress reports. FCA settlements regularly reach tens of millions of dollars.
Healthcare Fraud (18 U.S.C. § 1347)
Healthcare fraud is charged when fraudulent clinical data results in billing to federal healthcare programs. Up to 10 years per count. If serious bodily injury results from a drug approved based on falsified data, up to 20 years.
Collateral Consequences
Beyond incarceration, a clinical trial fraud conviction triggers FDA investigator disqualification under 21 C.F.R. § 312.70, debarment from federal grants and contracts, exclusion from federal healthcare programs, retraction of published research, institutional debarment, professional license revocation, and permanent reputational damage. The collateral consequences for researchers can be career-ending.
What Is Clinical Trial Fraud and Why Is DOJ Targeting It?
Clinical trial fraud includes fabricating or falsifying clinical data, enrolling fictitious or ineligible subjects, forging informed consent, falsifying laboratory results, and submitting fraudulent data to pharmaceutical sponsors or the FDA. DOJ’s Consumer Protection Branch identified clinical trial fraud as a focus of aggressive enforcement. The November 2025 creation of DOJ’s Health and Safety Unit signals dedicated prosecutorial resources for these cases. Clinical trial fraud undermines the drug approval process and endangers patient safety.
What Sentences Do Clinical Trial Fraud Defendants Face?
Sentences are severe. Dr. Martin Valdes received 60 months at Tellus Clinical Research. Eduardo Navarro received 46 months with $2 million restitution. Study coordinators received 24 to 30-month sentences. Sami Anwar, who ran fraudulent research sites for five years in Washington State, received a substantial sentence after over a dozen former employees testified that he directed them to falsify data. Wire fraud carries up to 20 years per count. FDCA felony violations carry up to three years.
Can a Principal Investigator Face Criminal Charges for Data Falsification by Staff?
Yes. Principal investigators bear responsibility for the conduct of clinical trials under their supervision. The government charges PIs under theories of conspiracy and aiding and abetting when they directed, authorized, or knowingly tolerated data falsification by study coordinators and sub-investigators. PIs also face charges when they signed off on case report forms containing data they knew was false. The PI’s FDA Form 1572 commitment to ensure adequate supervision is used as evidence of responsibility.
What Triggers a Federal Clinical Trial Fraud Investigation?
Investigations are triggered by FDA BIMO inspections, sponsor monitoring audits, whistleblower complaints, post-trial data analysis revealing anomalous results, employee tips, and ORI referrals. The T3D Therapeutics case was triggered by post-trial analysis revealing medically impossible results. The A&R Research Group case was triggered by the pharmaceutical sponsor detecting the fraud. The May 2025 expansion of DOJ’s Corporate Whistleblower Awards Pilot Program now covers healthcare fraud, including clinical trial fraud.
Does the Government Charge Pharmaceutical Sponsors for Site-Level Fraud?
Yes, in certain circumstances. Sponsors face criminal and civil exposure when the government alleges they knew about data integrity problems and failed to report them, submitted fraudulent data to the FDA, designed financial incentive structures that encouraged site-level falsification, or continued enrolling subjects at sites with known compliance failures. The Magellan Diagnostics case demonstrates that companies face both corporate criminal liability and individual executive prosecution.
What Is the Difference Between Research Misconduct and Criminal Fraud?
Research misconduct, as defined by the HHS Office of Research Integrity, means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research. ORI proceedings are administrative. Criminal fraud requires proof of intent to defraud. The same conduct can trigger both ORI administrative proceedings and DOJ criminal prosecution. ORI findings can lead to debarment from federal funding. DOJ criminal prosecution can lead to imprisonment. Both can proceed simultaneously.
What Should a Clinical Trial Site Do After Receiving an FDA Form 483?
Engage experienced defense counsel immediately. A Form 483 response is due within 15 business days. The response must acknowledge the FDA’s observations and demonstrate concrete corrective and preventive actions. A comprehensive and well-crafted response can prevent escalation to a Warning Letter, investigator disqualification, or criminal referral. The firm develops response strategies that protect the site’s interests while maintaining cooperation with the FDA.
Can a CRO Be Held Criminally Liable for Fraud at a Clinical Trial Site?
Yes. CROs face criminal exposure when the government alleges they knew about site-level fraud, failed to report data integrity issues, continued enrolling subjects at compromised sites, or submitted fraudulent data to sponsors. CRO monitoring obligations are defined by the study agreement and FDA regulations. The government uses monitoring failures as evidence of knowledge or reckless disregard. The firm defends CROs by documenting monitoring compliance and challenging the government’s theories of corporate liability.
What Is FDA Investigator Disqualification?
Under 21 C.F.R. § 312.70, the FDA can disqualify a clinical investigator from receiving investigational drugs and conducting future studies. Disqualification is a career-ending regulatory action for clinical researchers. Grounds include repeated or deliberate noncompliance with FDA regulations, repeated failure to comply with protocol requirements, and submission of false information. The firm represents investigators in disqualification proceedings.
Does Armstrong & Bradylyons Handle Clinical Trial Fraud Cases Nationwide?
Yes. Armstrong & Bradylyons PLLC defends individuals and companies in federal clinical trial fraud investigations and prosecutions in every jurisdiction. Enforcement is heavily concentrated in the Southern District of Florida, where multiple major prosecutions have originated. Active enforcement also occurs in the District of Massachusetts, the Southern District of New York, the Western District of Washington, and other districts. Scott Armstrong and Drew Bradylyons have tried healthcare fraud cases in federal courts throughout the country during their combined 25-year DOJ career. The firm is based in Washington, D.C.