QUALITY MANAGEMENT

Over the many years of our experience, SCOPE’s Quality Management Team has established a thorough quality management system which is audit & inspection proven. Our Quality Managers are an international, globally organized team working across all SCOPE locations, with representatives in our key offices to ensure a common, SCOPE-wide quality approach.

Apart from the routine tasks like audits, inspection participation, SOP & vendor management, our independent quality management team is deeply involved in our day-to day clinical trial business, providing quality consultancy to our project teams for external audit preparation, CAPA management, management of non-compliances and other quality-related matters. Our quality managers have a track record in auditing internal systems & areas as well as external parties such as vendors and clinical trial sites. We are active members of leading quality associations like the Research Quality Association (RQA) and other organizations to always be on top of quality and regulatory developments and updates in the industry. We have fully implemented risk management and are continuously developing our risk strategies further in line with ICH-GCP and other applicable regulatory requirements and guidelines. Apart from the assignment of a dedicated QA Consultant, standard quality tools for our projects are the development of a Study Quality Plan & Risk Assessment for monitoring performance and quality outcomes of all involved parties.

TRAINING MANAGEMENT

SCOPE’s Training Management Team has developed from our Quality Management Group and is a growing independent department, dedicated to supervising our employees’ training status, establishing location & group-specific training plans, updating existing training tools, and developing new training programs. Training Management is a central department, globally monitoring timely training completion for all employees in close cooperation with Quality Management. Our team has a regular in-depth exchange with all SCOPE departments to identify training leaders and efficient tools for training facilitation and to stay on top of  `hot topics` relevant for training.