A Big Thank You to All Our Poster Visitors at DIA 2019!
¡Buenos DIAs! Blown away that so many folks visited our QTLs vs KRIs poster presentation! Here is the infographic in the event that you plan to do home-work.
Jun
2019
May
2019
Centralized Monitoring: a Greater Advantage to a Broader Range of Trials
Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
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FDA Q&A Draft Guidance Document: The RBM Process-Technology Fit
Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.
Apr
2019
RBQM Software Features: What’s a Risk Flower chart?
Neat Features: wanting to dig a little deeper into the neat software features that make your risk-management life easy? Well, you’ve come to the right place. Learn more about Risk Flowers charts - a bunch of information.
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.
Jan
2019
Quality Tolerance Limits versus Key Risk Indicators, The Difference
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.
Nov
2018
Are Clinical Trials Safe? 6 Questions to Ask Before Enrolling
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.
Nov
2018
Patient Profiles – Better Understand Your Patients
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.
Oct
2018
Data Integration – A Valid Concern or a Convenient Excuse?
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.
Sep
2018
Optimizing Adverse Event Capturing and Reporting – 7 Questions to Ask
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.