Experts in IVD Clinical Performance Studies

Class D Diagnostic Test

• Challenge: Launch a Class D near‑patient and self‑test diagnostic under IVDR while also securing WHO prequalification—navigating two complex frameworks, tight timelines, and high sample‑volume demands.

• Approach: Devised a unified IVDR/WHO protocol to eliminate duplication and minimize total samples; executed four targeted studies (combined clinical, IVDR near‑patient, IVDR self‑test, WHO self‑test); acted as legal representative to streamline EC/CA approvals and site management.

• Result: Achieved first‑time‑right compliance for both IVDR CE‑marking and WHO‑PQ, cutting sample needs and accelerating time‑to‑market—paving the way for ongoing product collaborations.

Multiplex Respiratory Antigen Test

• Challenge: Secure CE‑marking under IVDR for a rapid, multiplex respiratory antigen assay (professional + near‑patient use) ahead of the busy respiratory‑virus season, despite shifting classification rules across analytes.

• Approach: Designed a lean, IVDR‑focused clinical performance plan; tapped our EU site network to fast‑track sample collection during peak season; handled ethical approvals, contracts, and logistics with agile oversight.

• Result: Delivered robust clinical evidence on schedule, enabling CE‑marking in time for the season and empowering the client to launch their differentiated respiratory panel across Europe.

• Helped the client obtain IVDR CE‑marking for a fully automated multiplex real‑time PCR panel detecting eight low‑prevalence STI pathogens.

• Crafted a lean clinical performance evaluation plan, optimized sample‑size calculations, and selected EU sites with access to the right patient cohorts.

• Managed site initiation, monitoring, and data logistics across multiple countries, ensuring full GCP and IVDR compliance.

Result: First‑time‑right protocol approval and on‑schedule CE‑mark submission, establishing a repeatable framework for future IVDR filings.

• Took over IVDR performance study sponsorship for a U.S.-based IVD manufacturer.

• Managed 8,000 samples across 100+ sites in 10 EU countries.

• Provided support for study design, medical writing, GMS & GDPR compliance.

• Coordinated EC/CA documentation and full Dx site monitoring.

• Acted as legal representative throughout the study lifecycle.

Result: Streamlined execution, expert guidance, and long-term planning flexibility.