Quality by Design quality system concepts (ICH Q8, Q9, and Q10) long used by the pharmaceutical industry and risk management tools will be presented from an industry and regulatory perspective on how to effectively select, manage, and overcome obstacles when outsourcing resources to run clinical trials to ensure that contracted services fulfill client, regulatory, and business expectations. Examples will be shown on how risk management models may be applied to conduct market analysis so that vendors may be ranked for consideration for clinical trials. A helpful checklist will be presented on how to conduct effective assessments and management of vendors. Examples will be provided on how to develop and implement vendor quality management plans which must contain specific elements to capture on each vendor to assure that vendors are appropriately ranked, assessed and managed. The future of new outsourcing models will also be described. Pharmaceutical representatives and regulators will compare and contrast different approaches to selecting the best vendors and areas of concern/ top findings from audits.