The relationship between a sponsor company and a CRO has always been a close one. Many smaller sponsor companies heavily rely on the services of CROs to get their products developed.
The relationship between those two parties has evolved over the years. CROs started as companies that were able to perform sponsor tasks, with the sponsor retaining the ultimate responsibility. That evolved into a relationship that more often than not includes a level of CRO consultancy to their sponsor clients, and the CROs sharing equally in the ultimate responsibility to protect the trial subjects and achieve reliable trial results.
R2 Sponsor-CRO Oversight
The R2 addendum to ICH-GCP added CRO oversight to the sponsors’ responsibilities. How does that affect the way sponsors approach the collaboration? And perhaps more importantly, their vendor selection? Where some relationships may have been built over years, and the collaboration provides the sponsor with ample opportunity to obtain insight into the metrics and the quality of the work that the CRO performs for the sponsor, when a new relationship needs to be started, how can the sponsor choose between the vendors, on the basis of their capabilities to provide insight into the work that they do.
One of the things that triggered ICH to include this CRO oversight language into the addendum, was the not uncommon situation that a CRO that was retained to perform duties for a sponsor outsourced part of that work to a third party, without the sponsor even being aware. It could, for example, be that the CRO did not have the resources in one particular country for an international trial, in which country they retained the services of a local CRO that they collaborate with, to support in their work for the sponsor.
The intention of the added language of GCP-R2 is not for the sponsor to become a hands-on micro-manager with their CROs. Being able to exercise oversight means that the collaboration between the sponsor and the CRO should be based on a high level of transparency in how the CRO performs the tasks they have been retained to perform for the sponsor.
To allow for the sponsor to maintain oversight, it is equally important to evaluate how that CRO communicates the progress of work, how they deal with issue escalation, and how they, in general, keep the sponsor informed about the work that they do.
Where a small, or even mid-size sponsor company is often heavily dependent on the services of their vendor, their relationship should not evolve into one where the CRO manages the sponsor. It needs to be absolutely clear that although often heavily consulted and advised by the CRO, the sponsor is the party making the executive decisions. It also needs to be absolutely clear that the CRO is keeping the sponsor apprised of their progress, any issues they encountered and how they handled them.
When a sponsor is in the process of selecting a CRO to work with, it is no longer sufficient to audit their procedures and evaluate their performance metrics to ensure that a qualified and capable vendor is selected. To allow for the sponsor to maintain oversight, it is equally important to evaluate how that CRO communicates the progress of work, how they deal with issue escalation, and how they, in general, keep the sponsor informed about the work that they do.
In the final draft of the R2 addendum, the language of ICH still indicated that the CRO could not outsource part of the work they are retained to perform to a third party without prior written agreement by the sponsor. Between the final draft and the final version, this stipulation was removed. This removal indicates that for the sponsor to maintain oversight, stipulating as much in a contract does not suffice. Oversight needs to be enabled through honest and transparent communication between the two parties.
Selecting the right CRO
The sponsor needs to choose the vendor that will provide them with enough information to be able to manage the trial properly.
How much information that is, totally depends on what project management and quality assurance capabilities the sponsor has in-house. Where previous experience, established communication and a built relationship with a CRO can certainly support a transparent collaboration, it could be worth to evaluate a couple of potential vendors when selecting the CRO for a next project.
Evaluate on the basis of their procedures AND their focus on enabling oversight. Maintaining oversight is not about micro-management. It’s all about communication.