One thing is clear – big Contract Research Organisations (CRO) like IQVIA, Covance, and Syneos Health have access to all sorts of data and tools. Additionally, they are able to cover a wide range of additional services. However, if you ask sponsors they often tell you they prefer to work with smaller CROs. Consider this:
- Being a smaller company does not necessarily mean that you cannot cover all services the sponsor needs
- Usually smaller CROs are experts in a therapeutic area or region, very well connected and focussed on driving for excellence
- Smaller CROs are generally more flexible in addressing the sponsor’s needs, and their prices (although the latter is not always true, as big CROs are trying to gain big shares in the biotech market)
Nonetheless, smaller CROs have one major disadvantage – the geographical coverage, which becomes eminent in Phase IIb, Phase III, or post-marketing studies. There are many excellent small to mid-size CROs, in no way inferior to the big corporations. Yet, the sponsor has a simple need they struggle with: running an international clinical trial. Some sponsors consider and accept managing more than one vendor. But let’s be honest, most sponsors realize the complexity of multiple vendor coordination – and decide to go to the big guys for overseeing the entire study.
Therefore, the question is – How do local CROs manage to work on multinational studies?
My team and I have spoken to more than a hundred regional CROs. All of them shared with us that when a sponsor approaches them, they need to submit an RFP tailored to their needs. This means that they often can’t only present their local capabilities, but prepare a proposal for other countries as well. This is especially true for the so-called “must-have countries” and where the sponsor focuses on marketing their product.
90% of CROs, who are asked for services outside of their local capabilities will submit an RFP with the support of a partner CRO.
Not all CROs have established partnerships with other vendors, but this is the way to grow and expand their offerings. This will position the company better in front of the sponsors.
Partnerships are very powerful when connecting two companies from the same therapeutic area with local excellence standards. This is particularly helpful for closer connection and communication with KOLs. Sponsors will benefit from the fact that each CRO has local heroes to engage with and ensure flexible project management.
For being awarded projects, the difficulty lies within the following questions:
- How can I find and work with a trustworthy partner?
- At which stage should I establish a partnership?
- How can I submit my RFP on time and still be able to add my partner’s capabilities?
The first two questions depend on the region and capabilities. The last one is a major challenge that might impair the quality of the RFP. Proposals have usually a deadline of two weeks, which renders it difficult to gather all required information from a potential partner in time. In this case, there are two scenarios that CROs use:
- The leading CRO knows the partners’ capabilities. Their proposals team will run additional research on the local situation, such as prevalence, competition, standard of care, etc. and simply include the information about the partner-CRO. This is preferable as it is more efficient and demonstrates cohesion between the partners.
- Often the leading CRO has no fixed partner and relies solely on indication feasibility research, competition analysis and past experience.
Final Words
In both cases, however, the leading CRO has to research and prepare feasibility assessments for locations outside of their core capabilities. This takes efforts and time, which might never be rewarded, particularly because smaller companies often do not have a dedicated feasibility team.