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Get the straight story on RBM in our new white paper Over the past few years, there has been much debate regarding the definition of risk-based monitoring. To put it in context, clinical monitoring – otherwise known as “traditional” monitoring – describes the oversight and administrative efforts involved in monitoring both a participant’s health and…
RBM (Risk-Based Monitoring) has been gaining traction since 2010 and has been called “the future of clinical trials.” This infographic explores what it means to truly perform RBM and how this method can improve speed, quality, and reduce the costs of a clinical trial. Download Whitepaper
Since the U.S. Food and Drug Administration (FDA) published its industry guidance, “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” in August 2013, risk-based monitoring has been a topic of discussion among the clinical research community.1 However, implementation has been a challenge and adoption has been slow. With the recent updates to the…
With the recent update to the ICH Good Clinical Practice (GCP) guidelines, risk-based approaches to clinical trials and risk-based monitoring are now requirements, not just recommendations. Now, sponsors and CROs alike face the challenge of adopting a formal approach to quality management which embraces technology and leverages access to real-time information to drive a more…
The first QMS that allows you to implement risk-based monitoring (RBM) methodology at scale. In this video, Mike Arlotto, founder of Remarque Systems, discusses how the Remarque Quality Management System can improve trial execution from the patient, site, and study levels with three distinct monitoring modules: Medical Monitor Module: View individual patient details and demographics…
Flexible access to clean, high-quality data and effective risk management are more vital than ever to the success of clinical drug trials. The Remarque Quality Management System is the first that allows sponsors and CROs of all sizes to implement risk-based monitoring (RBM) methodology at scale. In this video, Mike Arlotto, founder of Remarque Systems,…
Flexible access to clean, high-quality data and effective risk management are more vital than ever to the success of clinical drug trials. The Remarque Quality Management System is the first that allows sponsors and CROs of all sizes to implement risk-based monitoring (RBM) methodology at scale. In this video, Mike Arlotto, founder of Remarque Systems,…
Flexible access to clean, high-quality data and effective risk management. The Remarque Quality Management System is the first that allows sponsors and CROs of all sizes to implement risk-based monitoring (RBM) methodology at scale. In this video, Mike Arlotto, founder of Remarque Systems, discusses how the platform can improve trial execution from the patient level.…