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Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management

January 21, 2019 4:36 pm Published by Comments Off on Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management

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 [...]


What You Need to Know About RBM and the Future of Clinical Monitoring

January 21, 2019 4:30 pm Published by Comments Off on What You Need to Know About RBM and the Future of Clinical Monitoring

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


The Future of RBM Software

January 21, 2019 4:25 pm Published by Comments Off on The Future of RBM Software

A look back at the role of technology in clinical trials shows a succession of systems, each adopted to improve the speed, efficiency, and/or quality of the clinical development process while also reducing costs. Manual processes and paper-based record keeping were eclipsed by technologies such as clinical trial management systems and electronic data capture systems. [...]


Best Practices for Implementing Risk-Based Monitoring into the Clinical Trial Process

January 21, 2019 4:20 pm Published by Comments Off on Best Practices for Implementing Risk-Based Monitoring into the Clinical Trial Process

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 [...]


Risk-Based Monitoring Goes Mainstream with ICH GCP E6 Revision 2

January 21, 2019 4:15 pm Published by Comments Off on Risk-Based Monitoring Goes Mainstream with ICH GCP E6 Revision 2

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 [...]


Remarque Systems Overview Demo

January 21, 2019 4:10 pm Published by Comments Off on Remarque Systems Overview Demo

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 [...]


Remarque Systems Study-Level Demo

January 21, 2019 4:05 pm Published by Comments Off on Remarque Systems Study-Level Demo

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, [...]


Remarque Systems Site-Level Demo

January 21, 2019 4:00 pm Published by Comments Off on Remarque Systems Site-Level Demo

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, [...]


Remarque Systems Patient-Level Demo

January 21, 2019 3:55 pm Published by Comments Off on Remarque Systems Patient-Level Demo

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. [...]


Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management

June 28, 2018 6:06 pm Published by Comments Off on Debunking the Myths of Risk-Based Monitoring for a New Approach to Quality Management

The term “risk-based monitoring” (or RBM) has been widely used throughout the pharmaceutical industry, but what it really means and how it is implemented is the source of much debate. In this webcast, we’ll address five common myths of RBM and show how a quality management-based approach can set your clinical trial up for success: [...]