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ICH E6 (R3): The foundation for Modern Clinical Research Three decades ago, an international committee came together to create a revolutionary document designed to improve the efficiency of new drug development. Dubbed ICH E6, it has provided consistent guidance for clinical trials around the world. Today, plans are underway to update it for the second…
Delayed data delivery is a growing problem It’s 2021, and the digital revolution is well on its way. Yet, for clinical trials worldwide, real-time access to data is not the norm — and that lack can create a cascading set of issues affecting every aspect of a study. With critical decisions too often being made…
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 have questions about how to effectively gather collective insights and apply them to improve their clinical trials. The result is a call for risk-based 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…
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…
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.…