I believe that to determine if you should outsource a clinical trial or not, you should first develop a scope, WBS, Gantt chart, and budget for these tasks. This will give you an idea of how you would run the trial. Then contact a CRO and get a quote and outline of what they feel they can do. If they seem to have a better handle on the situation than you (suggesting good ideas that you didn’t think of) and its more cost effective, then outsource. If you believe that you can do a better job then do the clinical trial within the company. The factors that you would consider are budget, WBS, and the Gantt chart.