Today there are instances where more than 70% of clinical trial data points are not collected via eCRFs. Traditional data management and monitoring approaches using edit checks, listings compiled by programmers, queries, and 100% source data verification and review simply don’t work anymore. Increasingly, data management teams are evaluating approaches from clinical operations such as risk-based quality management to increase focus on critical data. This exciting and engaging roundtable brought industry experts across data management and clinical operations together.  Our speakers discussed:

• How have traditional processes and technologies for data management evolved with the rising complexity of clinical trials?
• What has fundamentally changed in how we now think about data cleaning?
• What opportunities exist for data managers to adopt risk-based quality management strategies into their work to ensure data quality?
• Where are the roles being blurred between the data manager, the central monitor and the CRA (Clinical Research Associate), and how can they work together effectively to ensure data quality and accuracy?

Speaker:

Stephen Hayward is a Director of Marketing at BIOVIA. He has a PhD in Chemical Engineering, with a background in laboratory informatics, chemical modeling, and environmental analysis.  Originally from Toronto, Canada, he currently leads product marketing efforts for informatics solutions at Dassault Systèmes BIOVIA in San Diego.