The Risk of Contracting

Whenever we ask someone else to take responsibility for something on our behalf, we take certain risks. When using a CRO, what is a risk that you could anticipate and how would you manage that risk?

Despite the meticulous design and planning all clinical trials base themselves upon, execution of these studies are lined with complications and challenges, as well as unforeseen risks. One risk I’d anticipate when working with a CRO is a lack of specificity. CROs often provide only the basic information to meet the statement of work, failing to provide specific detail and analysis that allow sponsors to recognize and mange risk. While understandable, considering that the more information a CRO provides, the more information they become liable to, this is extremely risky for the Sponsor who will now be working with a CRO that will not have to be liable for potential risks.

To combat this, a Sponsor may establish criteria that the CRO must meet when providing documentation and detail prior to establishing the CRO partnership. Such criteria could come in the form of requiring detailed documentation in a specific format, managing risk analyses and standardizing metrics of quality of performance. If a CRO is not willing to comply, it would be in the Sponsor’s best interest to look for a different CRO.


Categories: Clinical