The role of the legal representative for clinical studies – both in pharmaceuticals and now in medical devices under the EU Medical Devices Regulation (MDR) – might be described as quality assurance of the sponsor’s QA role.
In future, under the new EU Clinical Trials Regulation (CTR) and MDR, the legal representative will be responsible for “ensuring” the compliance of a non-EU sponsor.
“[The EU] legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Regulation” Medical Device Regulation (EU)2017/745, Art.62(2) and Clinical Trials Regulation (EU)536/2014 Art.74(1).
This is a complex role in the EU, as the legal representative can be taken to court should something go wrong with a study – and that can be for many different reasons, from patient safety concerns to investigator fraud or any other non-compliance issue. The purpose of the EU legal representative is to have someone based in Europe who is responsible under the jurisdiction of the EU courts, should any problems arise.
“The question CROs need to ask themselves is, are they comfortable that they’re going to have to take on that responsibility for a sponsor?”
Managing conflicts of interest
Acting a legal representative poses a potential conflict of interest for CROs, which is why it’s so important to understand what the role entails. The question CROs need to ask themselves is, are they comfortable that they’re going to have to take on that responsibility for a sponsor?
Under most CRO contracts, liability is released back to the sponsor. However, that will change with the new legal representative role and any contract will need to reflect these new requirements. In future, the legal representative will need to check the sponsor’s QA system and their audit schedule to ensure the Sponsor’s compliance with the Regulation(s), which adds complex layers to the CRO’s responsibilities.
Indeed, this is the premise under which Dr Harrison originally founded IDEA Regulatory, because even under the Clinical Trial Directive, which is less onerous than the CTR, he recognised the potential conflict of interest for his company, Harrison Clinical Research (now Synteract). By establishing an independent company, Dr Harrison kept his CRO business clear of any such conflict and built a business focussed on independently looking after sponsors’ compliance.
Talking openly about compliance
In my capacity as Managing Director of IDEA Regulatory, I have been working for sponsors for more than 13 years, which has allowed me and my colleagues to have really open and honest conversations with them about their compliance and what they’re doing with their studies. Furthermore, it allows sponsors to feel they can come to us very freely with any questions about what’s going on in a study, what the regulators might be thinking, if their strategy is appropriate and all of these questions that, quite often, CROs aren’t really set up to fully understand.
The role of the CRO is quite different to that of the legal representative, as is their experience and ability to advise the sponsor, or to be the QA to the sponsor’s QA.