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.
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?
Cyntegrity has updated the SandBox environment with the Version 3.5 of the RBM solution EarlyBird. The most informative & understandable graphs, robust KRIs, clear performance indicators will turn your experience with RBM analytics to a real adventure! Test it yourself. Free.
Cyntegrity's CEO Artem Andrianov to speak on the Germany ePharma day in Munich. The topic of the presentation is Practical methods how to master the new EU Clinical Trials Regulation with risk-based monitoring (RbM) See conference's program here. The event is focused on the new EU regulation [...]