Change as a Risk?
As change can be a significant source of risk, RBQM or risk-based monitoring (RBM) implementation programs should include a roadmap and change management plan for initiating a process of continuous improvement.
Feb
2020
Jul
2019
No Need for Data Detectives with RBQM
Spare yourself a fall-from-grace by so called 'data detectives'. Implement RBQM, better sooner than later, and detect problems prior to publication.
Jul
2019
A Clinical Research Must-Have: Next Generation Predictive Analytics
Predictive Analytics is seen as the next generation methodology: “growing across most therapy areas in the coming years”. Pharma companies and CROs that embrace next generation analytics will position themselves for immeasurable competitive edge in the industry.
Jun
2019
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.
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FDA Q&A Draft Guidance Document: The RBM Process-Technology Fit
Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.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
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.