IRT/ eDC audits can be some of the most confusing audits our clients have to deal with. IRT/ eDC vendors are responsible for the data obtained during a clinical trial. If there is a problem with your IRT vendor, your entire trial can be in jeopardy. Our IRT/ eDC auditors can help make sure that your IRT vendor not only complies with 21 CFR Part 11, Annex 11, and other regulations and guidelines, but they can also make sure that their capabilities meet your company’s very specific needs. It is always suggested that an audit be conducted before an IRT vendor is contracted but audits can be conducted at any stage of the process. Our experts can assist with:

  • Qualification audits to evaluate the capabilities and quality systems of a prospective vendor
  • For-Cause audits when there are concerns with the conduct of a study or the performance of a purchased product
  • Follow-up audits to ensure that the level of quality, service, and support verified during a previous audit is being maintained, particularly after there has been a major change in a supplier’s organization or significant upgrade to a product