Insights

Discussion on the Use of Placebell and FDA’s Feedback

January 21, 2025

Cognivia recently initiated a discussion with the FDA through the “Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program” process. A Letter of Intent (LOI) was submitted outlining Placebell’s methodology and seeking to explore Placebell’s applicability within the ISTAND for a wide range of statistical models. In response to the LOI, the FDA acknowledged that Placebell operates as

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Disruptive Technology Without the Disruption

January 10, 2025

Implementing an innovative technology within a clinical trial is about much, much more than the technology – and while the tech might be “disruptive,” its actual implementation shouldn’t be. Failing to anticipate and plan for operational challenges is something that has hobbled the growth of many truly innovative tech companies’ – especially those that assumed

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A “Unik” Approach to Capturing and Managing Patient Data

November 18, 2024

How the drive to maximize valuable data while minimizing patient and study team burden resulted in a unique data collection and management platform. Patient engagement is a delicate aspect within clinical research – especially in the current age of decentralized clinical trials (DTCs), hybrid, and mix-model trials. Balancing the need to gather as much comprehensive

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A New Era of Cognivia

October 10, 2024

Innovation, evolution and agility have always been core elements of drug and device development. How else, but through creative, out-of-the-box thinking and a willingness to innovate have we realized everything from mRNA vaccines and organ transplants to immunotherapy and nanomedicine. Believing in the impossible is at the heart of what we all do. Everyday. The

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Innovation with Integrity

October 10, 2024

It has taken a decade of scientific integrity and rigor – and a very particular mindset – for Cognivia to develop its current suite of innovative solutions. But there is a sense that we are just scratching the surface. Anyone who has experienced firsthand the frustrations that come from knowing a compound should work –

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Embracing Human Complexity in Clinical Research

September 12, 2024

As clinical trials become more diverse, patient heterogeneity, placebo responses, and inter-site variability become more pronounced, contributing to high rates of failed trials and extended development timelines and costs. It is time for the biopharmaceutical industry to reconsider its approaches. Most of the “unsolvable” challenges within the medical community – especially within clinical research –

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