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Most Recent Posts

COVID-19: A Wakeup...

Clinical trials have two key goals: to prove the safety and efficacy of new therapeutics. Their success rests on the accurate collection, monitoring, and analysis of data. While today's data...

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What’s Needed: An...

Risk-Based Monitoring. Risk-Based Execution. Risk-Based Quality Management. The monitoring and management of clinical trials are called many things—yet, they are, in fact, different. FDA Director...

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Alternative Monitoring: Clinical...

Effective Trial Continuity In the Face of a Pandemic While social distancing and isolation are paramount, clinical trials must adapt to remain viable. However, many clinical trial sponsors still...

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White Papers

The Future of...

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...

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Best Practices for...

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...

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Risk-Based Monitoring Goes...

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,...

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Video Posts

Remarque Systems Overview...

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...

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Remarque Systems Study-Level...

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...

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Remarque Systems Site-Level...

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...

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Blog Posts

What’s Needed: An...

Risk-Based Monitoring. Risk-Based Execution. Risk-Based Quality Management. The monitoring and management of clinical trials are called many things—yet, they are, in fact, different. FDA Director...

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Using AI &...

Against a backdrop of stricter regulatory standards and increased emphasis on trial oversight and patient safety, the clinical development landscape is more competitive than ever. Clinical trials...

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Making Risk-Based Monitoring...

Introduction Infused into virtually everything we touch, technology can feel like both a blessing and a curse. While some technologies are easy to use right out of the box, others require set-up in...

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