Selecting the right CRO to manage a clinical trial can be a critical decision in the program’s successful outcome. It is important to consider the experience of CRO in that particular area and important to consider the financial stability of CRO. Appropriate CRO infrastructure is essential to support your project requirements, Ask what software they use to track project performance and how their clinical information system is organized. Do they maintain clinical data in such a way that is 21 CFR Part 11 compliant? What steps must be taken to export data maintained at the CRO into your company’s system and is the process secure. How does the CRO manage essential study documentation? Ensure that your CRO has a proven track record of obtaining valuable patients and providing high-quality patient data and determining the actual number of patients that meet the inclusion and exclusion criteria of the study. The other important factors are cost,transparency and responsiveness.