Our integrated data solutions and advanced CTMS platforms allow us to identify, recruit, and enroll patients who meet strict Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) thresholds. We go beyond generalized inclusion/exclusion criteria to build cohorts that support both statistical power and real-world relevance.

We design study protocols tailored specifically to diagnostics, balancing analytical performance, usability studies, and real-world data capture. Our flexible, client-focused approach ensures that each protocol reflects your product’s unique characteristics, regulatory requirements, and intended use.

We specialize in diagnostics-focused regulatory strategy. From early-stage development, pre-clinical work, assay development, prospective screening, and post-approval surveillance, our regulatory teams guide you through every milestone, ensuring alignment with GCP, FDA, EMA, and other global standards.

With industry-seasoned program management and trial forecasting models, we deliver faster timelines without sacrificing quality. Our execution frameworks are built for diagnostics, enabling early identification of risk points, adaptive planning, and predictive trial performance monitoring.

We manage high-volume, multi-endpoint datasets using intelligent CTMS platforms, EDC systems, Decentralized Clinical Trial elements, and AI-assisted tools. Our systems are fully aligned with FDA GCP E6(R3), 21 CFR, and HIPAA guidelines, enabling real-time data insights, audit-ready documentation, and seamless integration with your internal teams or external platforms.