From Human Factors Engineering to eSTAR: Connecting Development to Submission
By Lisa M. Baumhardt, Senior Director, Regulatory Affairs CovarsaDx September 2026 Human factors engineering (HFE) and usability engineering (UE) have
Expert Insights
Design Discipline: How the Right Data and Design Drive Clinical Success
By Dennis Broyles, Sr. Director, Data Management & Clinical Strategist, CovarsaDx There are common patterns with most clinical studies. Every
How the Prevalence of COVID-19, Flu, and RSV is Shaping the Future of the IVD Industry
As respiratory illness season looms, bringing with it the usual suspects – COVID-19, influenza, and RSV – the demand for accurate and timely diagnostics has never been higher. With symptoms that blur the lines between these viruses, especially during peak seasons, healthcare providers are under pressure to deliver swift, precise diagnoses.
Finding Certainty in Uncertain Times: A Guide for Clinical Research Sponsors
What Every Sponsor Should Know About IVD and Medical Device Clinical Research Right Now By Clara Feider, PhD, CCRASr. Clinical
Rebuilding Trust in Clinical Research: Addressing Misinformation and Ethical Standards
Clinical research, especially in the fields of in-vitro diagnostics (IVD) and medical devices, plays a vital role in advancing healthcare solutions and improving public health. However, a pervasive issue facing the industry is the erosion of public trust due to misinformation and past ethical missteps such as the Tuskegee Syphilis Study.