The Importance of QMS and Vendor Oversight for Non-EU Sponsors Under The CTR

| by Deirdre Harrington

Good clinical practice is well-entrenched in global biopharmaceutical companies, and almost every sponsor company adheres to the Declaration of Helsinki with regards to following ethical principles in their medical research. For US companies, the standards established by the Food and Drug Administration (FDA) are very much in line with what is required in the European Union, and many other non-EU countries follow similar principles and standards.

Nevertheless, there are differences in running a clinical trial in the EU that require careful thought and oversight, such as having a quality person (QP) for the release of your drug or a qualified person for pharmacovigilance (QPPV) for all your safety events.

While the majority of non-EU companies would have a robust quality management system (QMS), there are roles and nuances within the EU clinical trial regulations that must be observed.

A robust QMS

As legal representatives, we would certainly hope that a sponsor’s contract research organisation (CRO) had clear processes for conducting clinical trials and we would expect the sponsor to demonstrate their QMS was adequate to ensure the effective management of that trial, including oversight of third parties delegated responsibilities, and such that we can confirm compliance with the regulations. If the sponsor’s QMS is not robust enough to cover most of the requirements in the EU, we would be asking them to address those discrepancies before we could act as the legal representative, otherwise we wouldn’t be able to be compliant with our role under the EU regulation.

“As the legal representative, we need to know that the sponsor has a robust QMS that covers the EU requirements.”

While a non-EU company would be unlikely to have standard operating procedures (SOPs) within their QMS related to the EU-specific roles – QP and QPPV, for example – they would need to make sure that the person they are delegating those responsibilities to has SOPs in place and has experience with performing that activity

Checking qualifications

So, as the legal representative, we would look to make sure that the sponsor has checked out the qualifications of that person or company that they’re going to work with for the clinical trial. It’s about ensuring they have done their due diligence in terms of making sure those conducting the study are able to comply with the EU regulations.

We would be looking to see that the sponsor is not only following the QMS processes and procedures, but that they provide us with evidence to that effect. Many QMS systems are huge and, as the legal representative, knowing all of the details within them would be fairly meaningless. What matters from our point of view is seeing the relevant records, so we know GCP standards are being met, and processes and outputs demonstrate clinical trial regulatory compliance in the EU.

About the author:

Deirdre Harrington is a Clinical Operations professional with a strong background in science combined with 20 years of experience in the device, pharmaceutical and biotechnology industries. Deirdre has broad experience with clinical research projects complying with ICH, FDA 21 CFR, EU GxPs and legislation, across a wide range of therapeutic areas.