Cyntegrity developed a special COVID-19 RACT that guides those involved in clinical trials on specific risks which may arise as a result of COVID-19, and how they can mitigate them. This special RACT is part of the COVID-19 rapid deployment pack for ad-hoc centralized monitoring.
We can help establish near real-time centralized monitoring, enable the use of "ad-hoc crisis management" Key Risk Indicators (KRIs), and mitigate patient safety and study quality risks.
Adaptive and intelligent Risk Based Quality Management (RBQM) is a powerful strategy for rare disease research. One of the main benefits is that RBQM allows for patient-centric trial design that is uniquely tailored to the specific rare disease.
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.