1. Permissible Clarifications After checking the audit trail for those who entered the data, the RBQM system revealed that at two sites in Japan, instead of site personnel, the sponsor company monitor entered the majority of the data into the EDC system [...]
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.
If you are thinking about joining a clinical research study, then you might wonder about the safety risks you should be aware of, as no clinical trial is completely safe for everyone.
Pharma today embraces the concept of patient-centered research. Innovators view Patients as informed collaborators whose participation is core to the overall success of clinical research. The risk-based Patient Profiles tool is a key contributor to the modern concept of patient-centered thinking, as It enables early detection and real time control of patient safety issues.
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.
Press Release: Cyntegrity Rolls out SaaS Application to Help Pharma Organisations Bring Regulatory Guidance into Practice
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.