2017 Compliance Institute

Does HCC apply to CROs?

  • 1.  Does HCC apply to CROs?

    Posted 01-26-2017 03:59 PM

    I am a new (started my job in September 2016) Healthcare Compliance professional (many years in human subjects compliance and research animal compliance seemed to convince Canon Biomedical to take chance on me!), and I am a new member of HCCA, thank goodness! I enjoy your blog and feel encouraged to send you my question!
    Canon Biomedical is a medical diagnostics device company that's still a couple years out from product sales to physicians and hospitals. However, we are currently embarking on a relationship with a contract research organization to help us address product assessment and the regulatory demands required to get the product to market. It seems to me that because we will be working with several physicians in the CRO, we need to get policies and procedures in place to govern our contracts with them, to assess fair market value of the services we will pay them for, and to assess whether they have any conflicts of interest to disclose.
    I have not seen any explicit application of healthcare compliance guidance to relationships with CROs--is the relationship between a medical device company and its CRO governed by healthcare regulatory and ethics standards, or by other business and legal guidance?

    Thanks for any help!

    Donna Sobieski
    Healthcare Compliance Manager
    Canon Biomedical, Inc.
    19th Annual CEI Virtual Conference