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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 collection is increasingly electronic, monitoring itself still largely occurs onsite, with monitors verifying source data by physically comparing the electronic data capture with the data…
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 of the Office of Scientific Investigations, David Burrow, notes that “Risk-based quality management is not just risk-based monitoring.” RBQM is a more substantial undertaking, requiring quality, reliability, and interpretability. It…
New technologies are inevitably heralded as making life simpler: streamlining tasks, eliminating steps, managing things so you don’t have to manage them. Yet the practical application of a new technology often seems to make things more complex. Clinical trial management is a case in point. Contract Research Organizations (CROs) and sponsors are juggling increased data…
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 have also increased in complexity, driven in large part by the shift toward biomarker-guided drug development and value-based outcomes. With about 7,000 medicines in development globally, nearly three-quarters…
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 order to be useful. At times, that set-up and even the eventual use of the technology can feel daunting and frustrating. However,…
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 capabilities of the Remarque Systems Platform. Speech Transforming FDAs Approach to Digital Health FDA Draft RBM monitoring FDA Seeks More Efficent Clinical Research…
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, real-time insights into every aspect of your trial, simplifying overall trial management and informing decisions that both limit risks and save time and money. Yet, many people find the prospect of…
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…