CovarsaDx presents its end-to-end approach to IVD and diagnostic clinical research at ADLM 2026
The team will also discuss evidence strategies for 510(k), De Novo, and PMA programs, as well as SitePath™ site operations function and TrialPathDx™ Clinical Trial Management System
30 Jul 2026
CovarsaDx® will exhibit at the Association for Diagnostics & Laboratory Medicine (ADLM) Annual Scientific Meeting & Clinical Lab Expo in Anaheim, California. Senior members of the CovarsaDx team will be on-site at Booth 1477 to meet with IVD and diagnostic medical device sponsors seeking end-to-end clinical research and regulatory support.
End-to-end IVD and diagnostic clinical research services
At the booth, the CovarsaDx team will walk attendees through its end-to-end approach to IVD and diagnostic clinical research, covering regulatory strategy, study design, site management, enrollment, data management, and submission-ready reporting.
Attendees can expect focused conversations on:
- Regulatory pathway planning for IVDs and diagnostic medical devices
- Protocol development aligned with regulatory submission requirements
- Evidence strategies built for 510(k), De Novo, and PMA programs
CovarsaDx partners with sponsors to design and execute clinical studies that are built to withstand regulatory review and support successful market access.
SitePath and TrialPathDx for proactive study and site management
The CovarsaDx team will also be available to discuss SitePath™, the company’s dedicated site operations function, and TrialPathDx™, its proprietary Clinical Trial Management System.
These capabilities are designed to support proactive study and site management, helping sponsors:
- Optimize site selection and activation
- Improve enrollment performance and oversight
- Enhance data quality and study timelines
By integrating operational tools with regulatory and clinical expertise, CovarsaDx aims to streamline IVD and diagnostic medical device studies from start-up through close-out.
“Successful regulatory submissions require more than just good study execution,” said Mark Boyle, Chief Operations Officer of CovarsaDx. “Clinical, regulatory, and quality strategies must work together from the beginning. We partner closely with sponsors to make the right decisions early and execute studies designed to hold up under regulatory review.”
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Frequently asked questions
What services will CovarsaDx showcase for IVD and diagnostic medical device sponsors at ADLM 2026 in Anaheim?
CovarsaDx will highlight its end-to-end IVD and diagnostic clinical research services, including regulatory strategy, protocol development, site management, enrollment, data management, and submission-ready reporting. The team will also discuss evidence strategies for 510(k), De Novo, and PMA programs, as well as its SitePath™ site operations function and TrialPathDx™ Clinical Trial Management System at Booth 1477.
How do SitePath and TrialPathDx support IVD and diagnostic medical device clinical studies managed by CovarsaDx?
SitePath™ is CovarsaDx’s dedicated site operations function, while TrialPathDx™ is its proprietary Clinical Trial Management System. Together, they enable proactive study and site management by optimizing site selection and activation, improving enrollment performance and oversight, and enhancing data quality and study timelines from study start-up through close-out.