The Importance of First-in-Human (FIH) Trials First-in-Human (FIH) clinical trials, also known as Phase 1 trials, are a pivotal stage in drug development. Conducted with a small group of healthy volunteers, these studies mark the first testing of a new drug in humans. [...]
The COVID-19 pandemic has accelerated alternative distribution strategy adoption to facilitate “new normal” decentralized and hybrid trial concepts. Capturing the IMP supply chain risks associated with these more flexible distribution approaches requires synergy among people, processes, and technology. Former Senior Project Manager at GKM, Anke Mueller, shares with you how pandemic-induced supply chain risk data knitted together in a single RAC tool enabled her study team to pivot quickly and continue their studies in a timely fashion.
Are you an orphan expert? Do you care about rare? We invite you to collaborate with us on a rare disease-focused RACT that will help reveal and address orphan drug trial risks more efficiently.
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.
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.
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.
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!
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.
Cyntegrity today announced the worldwide release of their Medical Device RACT, “MD-RACT”, the world’s first Risk Assessment and Categorization Tool for clinical investigations, that combines the best practices in Life Sciences with subject matter expertise in Medical Devices.
100% SDV...seriously, who DOES this? Start 2018 with an easier way to manage your clinical risks.
