Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
Our key risk indicator infographic will give you a foundational understanding of KRIs, provide valuable examples of KRIs, and guide you towards getting started with your risk-based monitoring (RBM) program.
To clear up confusion surrounding the interpretation and use of QTLs and KRIs, we have created an easy to understand infographic for all clinical research experts involved in quality control.
The dramatic expansion of prescription drug deaths inspired this year's theme "driving insights to action". Insights that could be deployed through novel disruptive technologies such as Risk-based Quality Management (RBQM). Cyntegrity's Johann Proeve and Nimita Limaye were in Boston and share their observations with us.
By design, the traditional spot-checking type of audits leave a blind spot on systemic quality threats. Key Risk Indicators however, form the core of a widely applicable concept that captures all relevant risks in scope and provides project managers and QM experts targeted and objective updates on actionable issues and trends.
Quality is a business decision. Everyone instinctively knows that poor quality doesn't come cheap, however until now no attempt was made to calculate the real difference between good and poor quality in clinical trials. Most of the issues that impact cost and expenses are lurking just below the tip of the iceberg.
How to avoid audit findings in a Risk-based Quality Management (RBQM) and risk management environment? What are auditors looking for?
J. Proeve, Ph.D., an expert with 35+ years of experience as Global Data Management Head at Bayer started this week as Chief Scientific Officer at Cyntegrity. He takes the responsibility of building up a proper Risk-based Monitoring (RBM) strategy for each clinical study and develop further Cyntegrity's core product RBM [...]
The majority of companies are delaying the RBM adoption. Why? The reason lies now in the nature of innovation adoption. The main hesitations of the pragmatists to apply RBM nowadays are connected with: the general complexity of the approach the perceived risk of audit findings [...]
Interview with Artem Andrianov during PCT 2015: What Pharma Gains from Structured RBM?
