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.
Many risks in clinical trials are therapy specific. Because of that, the currently available tools addressing those risks are now becoming therapy specific as well. The first therapy focused risk library Oncology RACT (OncoRACT) recently got available.
Yes you can stay on-budget! Read how Risk Based Budgeting (RBB) can help you keeping your clinical trial on-budget.
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.
Are your role connected with the controlling the quality, performance or risks of clinical trials? We are delighted to invite you along to this exclusive live webinar and Q&A session on February 23rd, 2018.
We are pleased to welcome Dr Nimita Limaye, Project Lead KRI Wiki, to the Cyntegrity team! Key Risk Indicators (KRIs) play a fundamental role in managing risk, you could say they are the “traffic lights” of clinical monitoring. When appropriately selected and calibrated KRIs [...]
There is a rapidly growing amount of information to process in clinical research. You could argue whether it adds value viewing and verifying the reliability of each single data point. Dirty data and frauds have always existed but can eventually be marginalised by responsive people and processes.
More than ever before, well-designed clinical trials are essential to maximize chances of success.