With 20 years of research experience, Heartland Research Associates, LLC has been audited for routine / high enrollment by multiple agencies to include IRB’s, sponsors and the FDA.
FDA Audits
January of 1999- The FDA reported no significant findings.
March of 1999- The FDA reported no significant findings.
January of 2006- The FDA reported no significant findings.
December of 2007- The FDA reported no significant findings.
Sponsor Audits
Heartland Research Associates, LLC has averaged about 8 sponsor audits a year and has completed each audit with positive reports.
IRB Audits
Seven routine audits by WIRB have been conducted at Heartland Research Associates, LLC. Each final report was commendatory.
* Heartland Research Associates, LLC has never been issued a 483.
|