Selecting a CRO
Question: I am in the process of selecting a CRO for our outsourced nonclinical studies. What characteristics or criteria are most important when considering a nonclinical CRO?
Answer: There is no simple answer to this question, but it is one of the most important decisions in an outsourced nonclinical program. No particular criteria or characteristics rise to the top in the selection process. However, there are several aspects to consider. Their individual importance varies based on your needs and current circumstances.
Daniel Nazarenko, PhD, DABT, associate director of preclinical development, Fulcrum Pharma Developments, Inc.
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Ideally, you should choose a CRO based on the quality of its facilities, the qualifications of its staff and an assessment of its capabilities and strengths.
This assessment should include a site visit to evaluate the facilities and staff; inspection of the facilities, procedures and standard practices; and a review of the credentials and training records of relevant members of the staff.
You should also look at the results of recent regulatory agency inspections. Then you can make a final selection based on:
- The experience of the CRO with the particular study design. This is particularly important with the more specialized or less common studies, such as genetic toxicology, reproductive/developmental toxicology or carcinogenicity studies.
- Cost. Although the total cost of the study is always a consideration, based on other factors, the least expensive is often not your best option.
- Ability to meet timeline needs. Depending on the phase of development of your product, this could be the most important factor.
- Availability of preferred study director. If you know a particular study director and are pleased with his or her work, you may prefer continuing to work with the same person.
- Geographic location. If the lab is difficult to access, you may not be able to monitor study activities as effectively or as often as you should.
- Availability of support services at the same site, including
analytical method development and sample analysis or bio analytical method development and sample analysis. Using a lab that is already running the necessary analytical method or has capacity to do the analyses to limit the need for shipping samples may be preferable.
However, when selecting the provider of these services, you should go through the same process as described for the nonclinical studies to identify the best-fit provider for your company.
