Case Study: Third Party Integrity Auditor

The manufacturer of an implantable medical device had a key submission placed on integrity hold by FDA due to questions regarding the accuracy of clinical data. This company retained Health Policy Associates Inc. to serve as an independent auditor and to assist them in defining and executing the required corrective action plan.

The company’s fundamental needs included:

  • Expediting the removal of FDA’s integrity hold to allow eventual submission approval
  • Evaluating its capability in conducting future clinical trials in a compliant manner
  • Preparing regulatory submissions in an efficient and compliant manner

In order to insure the client met the key objective milestones, HPA Inc.:

  • Conducted a system audit of the key aspects of the company’s operational capabilities
  • Conducted a clinical audit of over 1,800 individual clinical case files to verify the integrity of the submitted data
  • Developed a corrective action plan responsive to FDA requirements and the company’s needs and capabilities
  • Performed required audits and certification of regulatory submissions with minimal impact on submission timelines
  • Assisted company in identifying and hiring new regulatory/clinical staff, training existing clinical staff and providing ongoing oversight in areas of compliance.
  • Assisted in developing IDE protocols, CRFs, Oracle data structures, and monitoring plans to enhance both efficiency and compliance

Health Policy Associates Inc. involvement increases probability of success in both financing of and execution by privately financed companies.