12 Points to consider when choosing a Contract Research Organization

Is the company independent?

Does it have a well-defined organizational structure with unambiguously distributed responsibilities?

Does a well-established and independent QA system exist?

Is the staff properly skilled and available for individual support?

Is there a low turnover of personnel?

Is the GLP system applied overall, so that all studies can be performed in the same environment?

Can electronic data be securely stored with a secure access route for the customer?

Is there a state-of-the-art animal facility in accordance to the Animal Protection Law with an on-site veterinarian?

Is all equipment qualified and validated?

Does the portfolio include regulatory required tests in accordance to guidelines of EMA, FDA, ICH and MHLW?

Are internal and external audits regularly executed?

Is the CRO in a time-zone that allows a timely response to customer inquiries and a widespread availability?