Case Study: Clinical Research Organization uncovers widespread fraud and restores data integrity with Advarra Consulting

How We Helped a Clinical Research Organization With Fraud Investigation

Clinical Research Organization engaged Advarra Consulting to conduct a for‑cause investigation after owners suspected fraudulent activity and misconduct at one or more of their research sites. The challenge was to verify subjects’ enrollment and informed consent, assess data integrity, and determine adherence to ICH GCP and relevant US federal regulations across multiple studies and sites.

Advarra Consulting implemented a targeted audit plan—reviewing source documents, informed consents, demographics, and payment records, and using pivot tables and reverse‑lookup tools—to analyze more than 200 charts across two sites and 22 studies. Advarra uncovered suspected fabrication or falsification in 50 study charts, systemic protocol and oversight failures, and safety follow‑up gaps; as a result, the client reported potential misconduct for seven investigators to the FDA and notified study sponsors, providing clear, measurable outcomes.