Frederique Couttet, Clinical Trial Manager at Santhera, says small companies need transparency and simple procedures from CROs. During a conversation with Arena International, she emphasizes the importance of working with smaller groups to make quicker decisions.
CTA: What are some of the specific challenges small companies face during clinical trials?
FC: Small companies have to find a good CRO partner that will understand the needs of a small company as opposed to those of a big one, and to get the necessary attention all along the study and not only at the beginning.
CTA: What are the needs of small companies that CROs need to understand?
FC: It is better for us to work with smaller groups and to have more simple procedures. Big CROs put a big amount of their budget on global project management because they involve high profile people who, in reality, are not involved in our studies. Small companies need to work with a project manager who is mandated to lead the process and can make decisions without having to refer to the upper management all the time. The upper management should be there of course to ensure proper escalation process, but not day-to-day trial management.
We also need as much transparency as possible. We need CROs to understand what we are doing and to target the same goals as we do. We try to be very transparent with our strategy for the study and share the issues we come across internally. We are open to their expertise and give them room to express their ideas. We also need to have meetings with all the partners together, that they can have direct contact with one another and that they understand that the task of one partner conditions the work of another one. It is important also to have regular occasions to meet in TCs as a team when everybody is working far away from each other (in international trials for example).
CTA: Why do you need to work with smaller groups? And what are the benefits of that?
FC: When we work with smaller groups we see that we are more on the same level and that we understand each other better. It is simpler to build a relationship and to install trust with people in a company that understands the needs and challenges of a small pharma company like us. We are able to precisely define who is doing what to avoid misunderstanding and to take decisions more quickly. We save a lot of time stress working in this way. We also feel more motivation with our partners and that they put more effort into the things we are asking, even if the initial defined scope is slightly modified.
CTA: How hard is to get in touch with small CROs?
FC: Sometimes it is hard to get to know them and to get a recommendation because they are not well known. But we go to meetings like the ones Arena organizes and there we find many small CROs and we get the opportunity to network which can be very beneficial
CTA: Are there any challenges of working with small CROs?
FC: There are risks associated with small CROs because we rely on these partners to have good processes and structures and when you work with a well-known CRO you do not take that risk. We need to make sure we select the right ones and need to keep a vigilant oversight to ensure solid processes are in place that will be suitable for out trial.
CTA: How do you ensure that your CRO meets your need?
FC: We try to improve our experience by reviewing lessons learnt from previous studies and we audit our partners to ensure their process and structures are up to scratch.