IRO / Data Integrity Auditing

Health Policy Associates’ experience as a third party auditor for FDA Application Integrity Policy (AIP) is without peer in the industry. Since 1993, HPA Inc. has served as an independent auditor for FDA data integrity cases involving more than 35 separate submissions. No other firm can match this level of experience.

Health Policy Associates fully understands that companies involved in application integrity matters have both data integrity and compliance issues, as well as larger corporate management issues, each of which requires successful resolution.

Our services include:

  • Developing independent audit plans for FDA review and approval and auditing clinical sites
  • Writing integrity reports and managing FDA communications

Health Policy Associates has served as an independent review organization (IRO) under U.S. Government consent decrees and has been able to defer prosecution agreements by evaluating a company’s programs and systems regarding reimbursement and physician payments.

Our IRO services include:

  • Developing a work plan for the Office of Inspector General (OIG) review and approval
  • Performing Arrangements Reviews to ensure a company’s contractual and non-contractual arrangements do not violate the Anti-Kickback Statute
  • Preparing reports to review findings and submitting them to the OIG