Use of CROs in research and drug development in increasing. ADDF shared their recommendations for navigating CRO selection 1. We’ve summarized their insights in this series. CRO selection requires internal evaluation of a drug development program assessing where CRO use will be most beneficial. Followed by determination of the program needs and how oversight will be best be structured. Lastly, evaluation of the CRO structure and reputation is critical for program success.
CROs are commonly used to facilitate clinical trials. As such, the size of CROs can range from global organizations to small specialized units. Assess what the needs of your program are and what type of organization will best meet your needs. For pre-clinical needs, smaller local organizations that specialize in a therapeutic area may facilitate rapid and focused completion of a milestone. However, as a program progresses, it may be necessary to contract with larger global organization to successfully made advances. Larger CROs will likely have more experience and dedicated personnel to project management which will ensure a stronger line up. Additionally, the company’s stability and financial history should be investigated.
Using a reputable CRO can add value to your program. Established CROs have large networks of resources with years of experience and strong track records. CRO selection should include investigating past successes and failures, seeking independent and objective references, and evaluating their strengths and weaknesses. What is the primary area of expertise within the company? Are the services you are seeking their central area of expertise or is it a newly acquired service? Are there active training programs in place? Ascertaining the strength of the organization will help determine the reputation and strength that will be added to your program by working with them.
CRO use is becoming more prevalent throughout all stages of research and drug development. CRO selection can be challenging as many factors need to be assessed including the benefits of working with a CRO, and evaluating your needs and the capabilities of the CRO. At Assay Depot, we believe outsourcing can facilitate research and empower drug development programs to increase their efficiency.
1. Lane, R.F., Friedman, L.G., Keith, C., Braithwaite, S.P., Frearson, J.A., Lowe, D.A., Longo, F.M., Refolo, L.M., Watterson, D.M., Tsaioun, K., Shineman, D.W. and Fillit, H. M. Optimizing the use of CROs by academia and small companies. Nature Reviews Drug Discovery. 2013. 12:487-488.