Meet Astrid Myrset, Director of Clinical and Preclinical Research at AlgiPharma in Norway. In this Industry Viewpoint, Myrset speaks to CTA about why it's important for small companies to work with professional CROs that can adapt to them. What's more, Myrset shines a spotlight on the challenges of vendor selection and management processes.
CTA: What are the key attributes that you look for in a CRO?
AM: The primary requirements in our search for a CRO are competence and capabilities. This applies not only for competence to run clinical studies in general, but also related competence to disease indication, regulations and GMP. If they are competent, then the key attributes that we search for are clear accountability and good communication lines, so that we do not waste time and our clinical sites get the best service.
CTA: What are the benefits of working with those types of CROs?
AM: The start-up or small biotech sponsor is usually quite dependent on the performance of CROs, and working with professional vendors allows smaller companies to get the best people on board. In a competitive market, and in order to get the best investigators and key opinion leaders involved in clinical trials, small companies have to operate as professionally as possible at the early stages with limited staff and resources.
CTA: Is it better for you to work with big or small vendors?
AM: The size of the CRO is of less importance, as long as they have the required competences, professionalism and flexibility. A small CRO might not have the necessary competence in all fields and thus not be able to sufficiently fill the role as partner for a development stage company. If a big CRO is flexible enough to adapt to a small company, I think that could work just as well as a small/medium sized CRO.
CTA: If size is not really an issue, what are the challenges you often encounter when having to choose a CRO?
AM: It is a challenge for small companies to have the time and resources required to run sufficiently thorough vendor selection and vendor management processes. Therefore, in order to avoid wasting time in our search for good partners it is of great value for small companies to search for advice and recommendations from our own network, key opinion leaders and others with experience in the relevant field. Developing networks is therefore very important for small companies. Our company has had from the beginning a clear strategy of finding and working with the best specialists in every field within our drug development.
CTA: What are the typical challenges often encountered when working with a vendor, and how do you overcome those challenges?
AM: A typical area that might cause problems is related to roles and responsibilities. Being upfront when clarifying responsibilities is crucial for both the CRO and the small company. We prefer to clarify expectations and establish a clear responsibility matrix from the beginning. It is extremely important to have an open communication to resolve misunderstandings and issues early. Small development stage companies may have limited resources, experience and capacity in the clinical development field, but at the same time they have a very strong scientific knowledge and strong ownership of their drug and their IP. So CROs need to know how to be flexible to work smoothly with development stage companies.
CTA: What is the type of relationship that would be more beneficial for you to have with a CRO?
AM: We appreciate stable, long-term relationships with our CROs, where a low turnover of staff is helpful. We also have positive experiences with CROs that have been willing to enter into strategic relationships through participation in applications for public grants. CROs offering to co-invest with sponsors to perform clinical trials in return for 'first-right-of-refusal'-like options to perform future clinical trials for that sponsor, may be attractive for some sponsors, depending on the actual terms of such eventual CTAs.