Why IDEA set out to provide sponsors with a trusted, independent EU legal representative
While the Clinical Trials Regulation has clarified the role of the legal representative, IDEA Regulatory’s founder Dr Francisco Harrison recognised early on that it was more complicated and involved than many sponsors and CROs interpreted it to be.
Having supported clients in Germany, which has a stricter view of the legal representative than some other member states, Dr Harrison realised there was a conflict of interest with the role and the CRO business he ran, Harrison Clinical Research Group.
Francisco’s goal in establishing IDEA Regulatory in 2006 was to make sure that the liabilities and responsibilities of the legal representative were completely independent of what the CRO was doing, both for the benefit of the CRO business and for the sponsors that the company represented.
Having that separation ensured that any guidance on compliance would not conflict with work the CRO was doing during a study.
CTR and the role of the legal representative
While IDEA has been providing this service to clients for over 15 years, many of whom continue to work with us, this separation of legal representative and CRO has come to the fore with the CTR. Article 74 of the regulation requires that where the sponsor is not established in the EU, that they have someone established in the region to serve as their legal representative. That person is responsible for “ensuring compliance with the sponsor’s obligations pursuant” of the CTR.
As a legal representative, independent of a CRO, IDEA Regulatory can support non-EU sponsors to bring their clinical trials into Europe, understand the clinical trial regulation and make sure that they have robust enough quality management and vendor monitoring systems to “ensure” their own compliance. These are both important when conducting a study in Europe and complying with the EU regulations.
What can go wrong with a one-stop-shop?
While many non-EU sponsors have sought the apparent convenience of having their CRO act as their legal representative as a one-stop-shop, conflicts of interest can arise for many different reasons. The sponsor may use a different CRO for some markets and those CROs might not be willing to share data that the legal representative requires with a rival CRO.
There could also be business or relationship conflicts between the CRO and the sponsor, and that could put the legal representative in a tenuous position.
We see our role as the legal representative as preparing the sponsor for what will be required of them to conduct a trial in the EU and keep them in compliance with the EU regulations. Should something go wrong, because the sponsor is not in the jurisdiction of the EU, as the legal representative, we are responsible.
That’s not a responsibility CROs should take on lightly. Furthermore, it’s a role that is far easier to carry out effectively when it is kept separate from the job of conducting the trials.
“IDEA Regulatory was established to ensure that the liabilities and responsibilities of the legal representative were completely independent from the CRO.”