QUALITY MANAGEMENT

Quality and Safety net foresees following professionals to surround the CRAs to ensure top quality of the provided services:

• Back-up CRA (vacant CRA´s FTE to cope with the workload peaks, disease, vacation of study CRA). Main tool is Resources Plan (part of SanaClis Quality Manual)
• Supervising Manager with experience in international studies for major pharmacompanies. The manager will provide local and immediate clinical and non-clinical support if needed to ensure strict compliance with study timelines and objectives –including negotiations with authorities and institutions (customs, hospitals, regulatory). Supervising Manager works in close cooperation with local quality management person and reports regularly to Quality Director (certified by BARQA).