Intelligent Design That Gets Results
An optimized clinical study design approach also requires timely preparations of numerous clinical operations activities, including: CRO selection proces, country & site feasibility process, setting up and tracking of budget & timelines, development of the numerous study plans in cooperation with the selected CRO, and last but not least, the development and execution of a so-called vendor oversight plan, i.e., a plan ensuring adequate oversight of all vendors necessary to run the study on behalf of you as sponsor of the study. Our team can provide all these services, in order to support you in ensuring QA-GCP compliance for your study/program. In addition, our team can provide you with the responsible clinical trial manager of the study. This is a vital, ‘spider in the web’ role, making sure that sponsor, CRO and other vendors collaborate optimally in order to ensure the most efficient clinical trial execution.