Preparing to Adopt a Quality Agreement at a CRO: Check That Your Quality House is in Order
There should already be in place a strong quality program at the CRO and the quality agreement must make a good fit to this program. Those concerns (terms) that are rather common to Quality Agreements should already be addressed in the existing quality program at the CRO or else consideration must be given to incorporating them into the existing program. This approach is distinctly different and better than leaving them only in the quality agreement. To leave important concerns only in the quality agreement is tantamount to instructing the lab to only consider doing such quality work when working on this particular client’s project.