Driving Success in Cardiovascular Diagnostic Trials
At CovarsaDx, we’ve earned a solid reputation in respiratory diagnostics, helping companies like OSANG Healthcare, Nuclein, and Healgen bring their […]
Finding Certainty in Uncertain Times: A Guide for Clinical Research Sponsors
By Clara Feider, PhD, CCRASr. Clinical Research Associate, CovarsaDx The State of Clinical Research in 2025: Navigating Change and Uncertainty
CovarsaDx Strengthens Regulatory Expertise with Industry Veteran David Ikeda
Los Angeles, Calif., February 10, 2025 – CovarsaDx, a prominent Clinical Research Organization (CRO) well-known for its expertise in the areas
CASE STUDY: Accelerating IVD and Medical Device Research with Mednet
CovarsaDx, a leader in IVD and medical device clinical trials, faced a common challenge: efficiently managing vast amounts of complex
CovarsaDx® Research Team Provides Key Support for the FDA 510(k) Clearance for OSANG Healthcare’s Over-The-Counter QuickFinder™ COVID-19/Flu Antigen Self-Test and QuickFinder™ COVID-19/Flu Antigen Pro Test
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its expertise in the areas of in-vitro diagnostics (IVDs) and medical
Nuclein’s DASH® SARS-CoV-2 & Flu A/B Test for Use on the DASH® Rapid PCR System Receives FDA 510(k) Clearance and CLIA Waiver with Key Support from CovarsaDx® Research Team
CovarsaDx®, a prominent Clinical Research Organization (CRO) renowned for its in vitro diagnostics (IVDs) and medical device expertise, announced today that one of its clinical research study clients, Nuclein, LLC, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System.
CovarsaDx’s 2024 Year in Review: Pioneering Progress, Partnerships, and People
As we reflect on 2024, CovarsaDx has much to celebrate. This year was marked by milestones that showcased our commitment to advancing diagnostic innovation
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.
CovarsaDx Welcomes Tania Vogel: A Leader in Regulatory and Quality Assurance Excellence
CovarsaDx is thrilled to welcome Tania Vogel to the team as our newest leader in Regulatory and Quality Assurance. With a career spanning nearly two decades and a resume that reads like a blueprint
Quality/TMF Administration Assistant – Join Our Team in Downey, CA!
CovarsaDx is seeking a dedicated and detail-oriented Quality/TMF Administration Assistant to play a pivotal role in managing Trial Master Files