In the clinical research industry approvals for investigational products are not granted- they are earned. With FDA and International inspections on the rise, so are stress levels of everyone involved in clinical studies. Auditing can be looked at as a quality improvement process, and a way to prepare for inspections and approval by:
- Identifying and fixing issues before the FDA finds them.
- Getting ready for inspections by knowing what to expect.
- Addressing compliance concerns and gain reassurance
through Special Request Audits.
- Verifying that vendors have the experience to do their jobs.
- Prepping the research team with interviewing and coaching sessions.
Back in 2012 the FDA released a Guidance for Industry concerning auditing titled, “Voluntary Audit Report Submission Pilot Program.” According to the Guidance, the pilot program is voluntary and intended for device manufacturers previously audited under one of the regulatory systems implemented by the Global Harmonization Task Force (GHTF) founding members (European Union, United States, Canada, Australia and Japan) of the Global Harmonization Task Force (GHTF). The GHTF disbanded late in 2012. Its mission has been taken over by the International Medical Device Regulators Forum (IMDRF), a successor organization composed of officials from regulatory agencies— not industry — around the world.[These manufacturers may voluntarily submit the resulting report to the FDA for analysis. The FDA intends to use the audit results as part of its risk assessment to determine whether that establishment can be removed from FDA’s routine inspection work plan for one year from the last day of the audit.
"Companies that have successful compliance history, with few if any, minor deficiencies and no major observations will be well-positioned for the pilot program. With some firms subsequently removed from inspections schedules for one year, the FDA will be able to focus on more critical areas of concern within its mandate – namely the higher-risk areas within the industry,” according to an article on MD+DI.
With the Medical Device ISO program the hope is for investigational device manufacturers to be more transparent with the FDA, and allow for a more stream-lined process, and in term save time and money for all teams involved.
Auditing can help identify, analyze and strengthen weakness to ensure compliance, protect patients, and guard data integrity. IMARC offers auditing services, including:
- Site GCP Audits
- Sponsor/CRO Audits
- Vendor Qualification Audits
Auditing is an important process in clinical research which can help the entire research team effectively work through issues through the course of a trial. What do you think about this new pilot program? Do you think this will benefit the FDA and device manufacturers? Let us know your thoughts!
Photo Credit: sean dreilinger