Zooming in on three key areas; analytics-driven feasibility, patient-centric enrolment planning and Risk-based Monitoring, SCOPE Europe professionally facilitated high level discussions between pharma industry leaders and decision makers.
Cyntegrity today announced the worldwide release of their Medical Device RACT, “MD-RACT”, the world’s first Risk Assessment and Categorization Tool for clinical investigations, that combines the best practices in Life Sciences with subject matter expertise in Medical Devices.
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.
Last February 28th, the FDA finalized the E6 (R2) version of the addendum to the International Council for Harmonisation's (ICH) good clinical practice (GCP) guideline. What to do now? Don’t panic, we’ve put together a simple 5-step plan to help you initiate the most urgent process adaptations.
Frankfurt – Cyntegrity, a German provider of proprietary Risk-based Monitoring (RBM) cloud services for the Life Sciences industry, today announced the rollout of “@RACT-Pro” – simple and affordable risk assessment and mitigation tool. There is even a free version. This online SaaS (software as [...]
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.
Dr. Artem Andrianov, the Cyntegrity's CEO, will be presenting on the recent publication in Applied Clinical Trials at MCC's next meeting on 11-Dec-2017 at 10am EST. Registration link below. The link to the peer-reviewed Applied Clinical Trials article: http://www.appliedclinicaltrialsonline.com/pueks-project-process-innovation-clinical-trial-monitoring Registration (for MCC members only): https://metricschampion.webex.com/metricschampion/j.php?RGID=r606bfad2af43d9dcd6c74b1eb9b80ff7 [...]
MyRBQM® Portal's predecessor EarlyBird® RBM software deploys a powerful and flexible system for ad-hoc reporting of risk-relevant data. It can be used to explore clinical data in more detail, prepare centralized monitoring reports, and build up a risk overview across studies. The video [...]
Cyntegrity employees were happy to contribute to the new peer reviewed article in Applied Clinical Trials: "The PUEKS Project: Process Innovation in Clinical Trial Monitoring" http://www.appliedclinicaltrialsonline.com/pueks-project-process-innovation-clinical-trial-monitoring
In our previous "AI-driven predictive analytics in RBM" article, we started a discussion about algorithms of machine learning (ML), predictive analytics, and artificial intelligence (AI). We also covered that a risk software needs to calculate forecasts of Key Risk Indicators (KRIs) proactively and alerts [...]
