#USA #Las Vegas #CovarsaDx #Legal Compliance #Dr. Karen Shannon

CovarsaDx Welcomes Dr. Karen Shannon as In-House Counsel

In a significant move to bolster its legal, compliance, and innovative capabilities, CovarsaDx, a prominent contract research organization (CRO) focusing on in vitro diagnostics (IVD) and medical device clinical research, has appointed Dr. Karen L. Shannon as in-house counsel. Dr. Shannon brings an impressive track record of over 20 years, assisting various diagnostics and biopharma entities navigate the intricate landscapes of intellectual property, regulatory requirements, and commercial engagements. This addition signifies not only CovarsaDx's approach to ensuring robust compliance as it expands, but also reflects its dedication to maintaining high standards amidst rapid growth in the healthcare sector.

Prior to joining CovarsaDx, Dr. Shannon held a notable position as senior vice president and general counsel for SeeGene USA. There, she was instrumental in establishing the first U.S. legal department, managing a wide array of legal and compliance issues, thus demonstrating her adept ability to lead within dynamic environments. Additionally, she contributed to Danaher Corp. for over ten years, operating in vital roles such as vice president of intellectual property at Beckman Coulter Diagnostics and assistant general counsel overseeing Danaher's global diagnostics initiative.

Chermaen Lindberg, president and CEO of CovarsaDx, articulated, "As CovarsaDx evolves, having dedicated, in-house legal expertise becomes essential for our operational agility and responsiveness to sponsor expectations. Karen's extensive experience—spanning diagnostics, intellectual property, and regulatory law—will be integral as we pursue the integration of AI technologies into our clinical operations. Under her guidance, we aim to responsibly advance how AI-enabled investigational tests are developed."

In her new capacity, Dr. Shannon will collaborate closely with CovarsaDx’s regulatory, quality, and clinical teams, supporting the organization's growth trajectory while ensuring the seamless adoption of cutting-edge technologies and efficient processes. She echoed the sentiment, stating, "In-house counsel plays an essential role in striking a balance between innovation and accountability. Here at CovarsaDx, I’m excited to fortify our legal structure and compliance foundations while advocating for the thoughtful utilization of AI and automation in managing clinical studies."

CovarsaDx stands out as a leading CRO deeply invested in the innovative landscape of in vitro diagnostics and medical devices. It adeptly responds to patient population needs and adjusts to fluctuating regulatory requirements, providing rapid pathways to market. The organization brings together a team composed of regulatory strategists, quality assurance experts, study managers, monitors, data managers, and statisticians. This collective expertise enables CovarsaDx to deliver credible clinical outcomes that facilitate clients in efficiently bringing lifesaving technologies to market.

Dr. Shannon's appointment marks a pivotal step for CovarsaDx as it continues to navigate the evolving complexities of clinical research, underscoring its commitment to compliance and innovation in an increasingly competitive industry landscape. The company's strong legal framework, aligned with a visionary approach to AI integration, reflects its readiness to adapt to future opportunities and challenges in diagnostics and clinical research.