CRO Selection and Monitoring Short Course Overview Introduction Overview On CROs • Mega-CROs - Who are they and what services do they provide? • Niche Providers - Do the specialists offered the needed services? Common Outsourcing Strategies • Virtual Company - Offering everything for everybody? • Pre-selected - Qualified and guaranteed availability? • Special Study - A "pair of hands" for one or two studies? Sponsor Items To Be Accomplished Before Contacting CROs • Drug Discovery Or Drug Development Plan • Overall Outsourcing Program • Responsibilities and Accountabilities • Specific Study Designs • CRO Review For Research Studies To Be Outsourced CRO Selection Process • First Contact With CROs • Study Design(s) Submission • Proposal Review and Evaluation • Site Visits and What Should Be Evaluated • Contract Negotiation and Award CRO Monitoring Process • Study Set-up, Including Necessary Supplies • Critical Phase Monitoring • Frequency • Critical Stages • Support Laboratories • Problem Assessment and Correction Study Report • Data Review and Interpretation • Draft Report Review and Correction • Study Audit • Final Report Summary and Conclusion