Our expert team reviewed the March 2019 RBM Q&A guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.
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.
Even without it being mandated, health authorities typically expect pharma and biotech companies to conduct two well-controlled Phase 3 trials demonstrating efficacy and safety. Still today this principle ensues discussions regarding the quantity and quality of the evidence needed to establish effectiveness.
2018 has been an amazing year at Cyntegrity! Thank you to everyone who made this possible!
MCC Congratulates the 2018 Class of MCC Champions: "MCC bestows this special honor to those individuals who made significant contributions in 2018 in advancing the MCC mission to improve the efficiency, quality and effectiveness of clinical trials."
Conference season has started! Our first stop was the Global RBM Summit 2018 in London. Our CSO Dr Johann Proeve was invited to join the conversation as a speaker on the topic “Pragmatic Centralized Monitoring – How to get there?”. Johann shares his observations with us.
Cyntegrity is growing! Our new office is 3 times bigger as before! We're excited to announce that our team has moved to a new, more spacious office in Frankfurt's science and technology center.
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.
The EU MDR is setting the stage for busy times ahead. The continuous need for clinical evidence, the increasing complexity of new medical devices, and the size and global nature of medical device trials introduce a greater potential for error. Learn how a risk-based approach enables MedTech manufacturers to better understand, manage and mitigate the growing uncertainties.
Many risks in clinical trials seem therapy specific. To illustrate this, Dr Johann Proeve shares real life use cases he experienced during his years as Head of Global Data Management at Bayer HealthCare.