The first CROs emerged 35 years ago and since then clinical outsourcing has become the norm. However, 'despite considerable efforts towards harmonization and standardization, the level of Sponsor satisfaction still appears to depend on factors such as individual CRO project team members, the location of the CRO affiliate office, or the nature of the services outsourced'.
At Partnerships in Clinical Trials Europe, Mike Jagielski, CEO at KCR, Virgil Simons, President at Prostate Net Europa, and Anna Matranga, Managing Director at AMC Alliances & Consulting, gave their perspectives on the evolving relationships between CROs and the pharma industry. Each has suggestions for how best to innovate such partnerships - watch the full interviews below or here.
‘I think it's about having all the parties agreeing on who is responsible for what and following through with these concepts throughout the study; being very clear with each other who has what responsibilities in the execution. I think eventually, with clear delineation in responsibilities, comes empowerment, empowerment on the side of the CRO, and empowerment on the side of the sponsor and of the client.
I would also go so far and say, I would not want to take away empowerment from the sponsor company. It’s their project, it’s their baby, it’s what they’ve worked on for many, many years and you, as a CRO, are only part of it for a certain period of time. We have to respect that and let pharma companies to be part of the execution.’
- Mike Jagielski, CEO, KCR
‘Sponsors have to look at the functions that CROs are going to be charged with performing. Obviously, they are going to be looking to implement and execute clinical trials in terms of recruitment monitoring evaluations. The questions that have to be asked are: are the CROs really doing the complete job that they’re charged with?Are they really recruiting the right patient populations? Do they understand where those patient populations are? Do they speak to the patient populations? Do they have the appropriate partnerships with patient advocacy organisations that can help them set and meet those goals?
The question comes down to engagement. Are we creating the right partnerships? Are we having the right partners to achieve the mission we are really setting out to perform?’
- Virgil Simons, President, Prostate Net Europa
‘If you look at the pharma industry over the last 10 or 20 years, we’ve entered into more and more partnerships and collaborations. Historically, it was pharma-CRO, then we had CRO in the sites as well as pharma in the sites. I think we need to take into account that our collaborations may become a little complex, but they also needs to involve the right stake holders. We need to have the pharma-to-pharma, we need to have the pharma-to-CRO and we need to have the pharma, CRO and sites as well.
When I say sites, it’s not just about the investigator sites, but it’s about the patients too, so we need to be a lot more conscious and focussed about where those relationships lie, and what our objectives are to make sure we have the right stakeholders.’
- Anna Matranga, MD, AMC Alliances and Consulting
Positive steps have clearly been made to innovate the relationships between CROs and the pharma industry, but there is a shared belief in the need for clarification between multiple parties to be established. It will be a continuous development that all sides will need to participate in.