Michael Zörer, Head of Clinical Operations at AOP Orphan Pharmaceuticals, explores the unique challenges of building a successful partnership between big CROs and small pharma/biotechs.
It is difficult for smaller pharma or biotechs to establish a long-term successful relationship with the big CRO players, despite the fact that recently significant efforts have been taken by CROs to make this work. It really depends on the type of smaller company that you are, and your specific situation. Outsourcing to one of the top 10 CROs may work fine if you are a virtual company and intend to outsource a whole development program to a CRO partner, ideally you happen to have financial tailwinds by venture capital and need to be less sensitive in your spending. For a more mature company that wants to retain oversight and retain several aspects of the management of a study program in house, other outsourcing options may be preferential.
Unique requirements versus Big Pharma
A solid understanding of the client’s needs and the ability to cooperate with smaller companies is required. Let me give you two examples that may reveal that “cultural mismatch” that is often cited. You start your discussions on a project by signing a confidentiality agreement, which should be very straightforward and simple. If this process starts with a complete revision of your template and you get a trackchange doc back from US legals requiring several rounds of discussion, that does not look like the ideal start.
Another example is when you receive a communication plan highlighting numerous escalation levels from the project manager via country/regional leads until ending at someone with enough decision power to resolve a potential problem. How should you mirror that if you only have one or two levels to offer, but probably can bring in immediate decision makers?
Will the recent development of large CROs launching biotech divisions really be able to adequately address the needs of smaller companies? In my view this remains to be seen.
Case study: What does good look like?
I have the pleasure to have cooperated with PSI, a mid-size CRO, for more than 12 years now. When running a multinational or even global clinical trial, you need a broader reach and robust structures and processes in place that small/niche CROs may not be able to provide, making a mid-size CRO a suitable partner in such projects.
This cooperation has proven to be a very fruitful relationship, resulting in numerous extensions of the original contracted work, and is still continuing. While PSI has grown significantly in size over these years, they could maintain the spirit to deliver results in time and have an extremely high retention rate when it comes to key staff. In short, I believe they could maintain their DNA, to use that metaphor. Personal relationships, an atmosphere of trust and mutual respect and a commitment to the success of the long-term cooperation are excellent resources to navigate through the stormy waters that clinical development programs often represent.
We also have established very successful partnerships with local small CROs providing an efficient solution for conducting smaller local or regional studies. Using flexible outsourcing solutions enables us to use the optimal model for each project, best serving our, our clinical sites and our patients’ needs.