Independent Oversight: Why It’s a Risk to Have Your CRO as Your Legal Representative

| by Deirdre Harrington

In theory, there is no reason and nothing in the Clinical Trial Regulation (CTR) that prevents a contract research organisation (CRO) being named as the EU Legal Representative by a Sponsor. However, it does beg the question as to whether there would be a conflict of interest, since what it means is the sponsor is giving the CRO permission to oversee themselves when ensuring compliance with the regulation in conducting a clinical trial. And that sounds very much like self-regulation, which has caused all sorts of problems in various industries over the years.

That issue of potential conflict of interest is one reason why it is advisable to have an independent company that has no relationship with the CRO act as the legal representative. Having that objective oversight creates an additional safeguard for the sponsor. After all, if the legal representative is an employee of the CRO, it’s debatable whether they can flag issues with senior management without causing conflict.

For companies taking on the legal representative role, it’s often a matter of familiarity with longstanding requirements as well as the new mandates under the CTR. It is, therefore, less complex for those who have been doing this role under the Clinical Trial Directive, otherwise it is a steep learning curve.

“If the legal representative is not in a position to provide unbiased advice and communicate unreservedly with the sponsor, in addition to be being unable to ensure the sponsor’s compliance with the EU regulation,   they are in a vulnerable position in being able to discharge their responsibilities under the regulation”

Another consideration is that the legal representative is under the spotlight because they are named on official documentation. That person is the main contact for the EU regulators, which means they are acting on behalf of the sponsor and have the same responsibilities and liabilities for addressing non-compliance and ensuring corrective actions are implemented. So, if the legal representative at a CRO anticipates reprisals from senior management in reporting non-compliance or that result in required corrective actions, they are in a very challenging situation.

Due to the nature of the legal representative role, it is critical that the sponsor and legal representative have effective and clear communication channels. If the legal representative is not able to provide unbiased advice and communicate unreservedly with the sponsor, in addition to being unable to ensure the sponsor’s compliance with the EU regulation they are in a very vulnerable position in terms of being able to discharge their responsibilities under the regulation.

What, then, does the role involve?

To avoid going down a rabbit hole of reviewing and requesting information that has no relevance or isn’t required, while avoiding potential risks, companies taking on the legal representative role should have experience in a number of areas, including:

  • Knowledge of the EU regulatory framework
  • Understanding the whole clinical trial life-cycle
  • Understanding of Quality Management Systems and critical processes required to conduct clinical trials under CTR
  • Knowing which areas are most likely to be prone to having non-compliance issues or be deficient
  • Be pro-active and able to take steps to inform the sponsor and ensure they address issues that may affect their compliance with EU regulations

A CRO responsible for other CROs

Smaller or even mid-sized CROs may well not have presence in markets where the sponsor wishes to conduct some of their trials. In those cases, the sponsor will use a third party to conduct trials in those additional markets. But it’s very unlikely that the main CRO would want to take on the legal representative role for those CROs or that those other CROs would be willing to share their quality management system or other confidential information with another CRO. The problem is that there can only be one named legal representative for a trial, and, since that person is legally responsible, they must be able to access any clinical trial information relevant to their role.

Having an independent company manage the role of the legal representative removes that issue and provides all parties with greater confidence when sharing information, always within the bounds of confidentiality agreements.

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.