Insights
Why Better Data Now Matters More Than Better Tools
There comes a moment in every industry when the conversation subtly shifts. Not because a single breakthrough changes everything, but because long‑standing concerns finally converge into a shared understanding: current approaches are no longer sufficient. That inflection point was clearly visible during the recent Fortrea Innovation & Technology Summit in Boston. Across panels, workshops, and
The Behavioral Layer: An Overlooked Determinant of Clinical Success
Clinical research continues to evolve at an impressive pace. Digital technologies streamline data capture, biomarkers deepen biological insight, and innovative trial designs broaden access for diverse populations. These advances have unquestionably accelerated development and expanded participant reach. Still, across all this progress, one dimension consistently shapes outcomes yet remains underrepresented in planning, modeling, and oversight: patient behavior. Behavioral factors like motivation,
Discussion on the Use of Placebell and FDA’s Feedback
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
Disruptive Technology Without the Disruption
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
A “Unik” Approach to Capturing and Managing Patient Data
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
A New Era of Cognivia
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