Cyntegrity Launches MyRBQM® Portal
MyRBQM Portal is world's first one-stop clinical trial optimization solution and opens the door to fully fledged risk-based quality management. Get your free user license today!
Jun
2019
Apr
2019
FDA Q&A Draft Guidance Document: The RBM Process-Technology Fit
Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.
Mar
2019
Your Practical Guide to Understanding Clinical KRIs
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.
Feb
2019
3 Critical Aspects of Clinical Trial Conduct that Affect the Totality of Evidence
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.
Mar
2018
Blockchain in Clinical Trials – The Ultimate Data Notary
Blockchain technology is the biggest achievement in cryptography of the past decade. Source Data Verification (SDV), which consumes about 20–30% of the clinical trial budget nowadays, will become redundant when blockchain technology disrupts the pharma industry.
Dec
2017
Lean Six Sigma, a different term for the same concept
Believe it or not, it was Guinness’ biochemist Gosset who developed the first Six Sigma statistical test in the early 1900s. The Guinness brewery was far ahead of its time by hiring statisticians, chemists and other scientists to improve the quality of its beer.