Quality Management Procedures

• Blind review of data
• Pre-analysis discussions between data management and statistical teams

From the design of the project we concentrate on the key questions to be answered and develop a data management and analysis strategy to meet these goals. Our procedures ensure that the appropriate data are collected to a consistent high quality, delivered to the sponsor within set timelines, using the most up-to date statistical approaches, whilst complying fully with global regulatory requirements.

Our project data managers and statisticians are involved in a blind review of the data. Patient and data evaluability is determined prior to database lock, in close collaboration with the sponsor.