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.
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.
2018 has been an amazing year at Cyntegrity! Thank you to everyone who made this possible!
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.
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."
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.
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.
Adverse Event (AE) reporting, identified by the FDA as one of the most important challenges in clinical research, is known to be prone to under and over-reporting. When starting a project and considering the various ways available to capture the adverse event data, it’s important to ask yourself some analytical questions that help you improve AE and SAE capturing and reporting.
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.
