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Most Recent Posts

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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What the FDA...

These documents are either from or about the FDA and its concerns about clinical trials. What’s more important is that the concerns addressed within these articles can all be addressed with the...

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Technology: Friend or...Technology Friend or Foe title slide

 Today, risk-based monitoring (RBM) of your clinical trial is simple thanks to both integrated and standalone technology solutions. Such technologies can provide seamless, in-depth,...

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White Papers

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

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...

Read Article
Technology: Friend or...Technology Friend or Foe title slide

 Today, risk-based monitoring (RBM) of your clinical trial is simple thanks to both integrated and standalone technology solutions. Such technologies can provide seamless, in-depth,...

Read Article
Debunking the Myths...

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...

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