Current Edition

Risk-based Quality Management: Improving Trials Data through Minimalism

There is no doubt about the importance of maintaining
quality standards throughout clinical research processes, but
in recent years the regulatory bodies have begun to question
the industry’s approach to quality management. This has led
to an addendum to the good clinical practice guidelines that
advocate rethinking of current quality management practice
during clinical trials. Gunnar Danielsson, Senior Regulatory
Advisor, PCG Clinical Services, considers the new way of
thinking, which promises to allow more focused and cost-

effective trials that could reduce considerably the enormous

time and cost burdens of current quality management