Under both the Clinical Trials Directive and Clinical Trial Regulation, changing your legal representative is considered as serious as a change of sponsor, and involves a substantial amendment. The reason for this is that the liabilities of both the legal representative and the sponsor are tied to one another.
For companies that have selected a contract research organisation (CRO) as their legal representative, there is another key consideration, which is, if you are changing your CRO you have one more vital piece of work you need them to hand over to a new provider – that legal representative responsibility. And that can be an incredibly difficult conversation to have.
While an amendment is required, the transfer process itself is relatively simple, since it’s largely administrative. The sponsor simply needs to fill out a couple of forms and the legal representative must fill out and sign power-of-attorney documents to state that they accept this responsibility from the sponsor.
Cost and time considerations
The sponsor does still have to plan for the timelines and budget involved in making those substantial amendments. It’s still time and effort.
The legal representative would typically include any cost in standard setup costs or when taking a new study on. The previous legal representative would also likely charge for any time spent dealing with forms and sending over information required to close out the representation.
A major reason for switching your legal representative is to avoid any conflict of interest, which can and does arise when using your CRO for this role. As previously noted, having a one-stop-shop where you appoint your CRO as your legal representative might seem convenient, but it does also mean having all your eggs in one basket, along with all the challenges and conflicts of interest that go with that.
Getting your legal representative set up
In addition to cost considerations for setting up your legal representative, you also need to allow plenty of time to bring someone on board. In the past, under the directive, the process was fairly seamless and, in fact, our record from request to the client submitting their documentation to the local authority and ethics committee was under a week. The main hold-up – if you can call it that — was getting legal teams from both parties to review the contract.
Now, under the CTR, that quick turnaround is not feasible. To ensure we can meet our obligations under the regulation, we must carry out a thorough assessment. The time involved depends on the size of quality management system, the sponsor’s availability, and how quickly they can provide the documents and, where needed, remedy any issues we uncover in our assessment. Potentially, that process can take up to three months, and if the QMS is not up to the standard required, that timeline can stretch out even further to get compliance systems in order.
Retaining independence
Our advice is that it always important to ensure that your legal representative is independent, particularly under the CTR, where the legal representative is responsible for “ensuring” compliance. Staying independent is something we take very seriously and it’s why we won’t subcontract through CROs. We were set up to be independent. We stay independent so, if problems arise between the CRO and the sponsor, there is no potential for your legal representative to be compromised.
There are not only commercial and legal considerations for retaining independence, but this also further guarantees integrity in terms of being able to offer unfettered compliance advice. Furthermore, if your legal representative is independent and separate, they can work with multiple different CROs, retaining good relations with all parties, while providing the regulatory support the sponsor needs.
“Staying independent is something we take very seriously, and it’s why we won’t subcontract through CROs.”