The need for a controlled research environment adds another risk dimension to the Phase 1 study design. The new Healthy Volunteers - Phase 1 RACT serves as a helpful source to ensure maximum subject safety and a reliable outcome.
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.
Heart Failure (HF) is a complex clinical syndrome. Our CSO, Dr Johann Proeve, explains the challenges associated with the conduct of clinical studies in the various heart failure stages.
ICH E8(R1) discourages the old-school “one size fits all” approach, instead the modern day guidance encourages bio-pharma to go beyond the traditional checklists. We've visualized the 2019 guidance "General Considerations for Clinical Studies". Download our free infographic today to be ready for tomorrow.
Spare yourself a fall-from-grace by so called 'data detectives'. Implement RBQM, better sooner than later, and detect problems prior to publication.
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.
¡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.
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!
Regulatory bodies are unanimous, today's clinical research needs Centralized Monitoring. We summarized Centralized Monitoring the infographic way, download your free copy here...
Our expert team reviewed the March 2019 RBM Q&A draft guidance document and extended the FDA guidance with RBM solution specific insights and a MindMap to help you even further.