Comprehensive clinical research services, from strategy to submission

Clinical Operations

We manage Phase I–IV trials with a focus on rapid site activation, diverse patient recruitment, and real‑time risk monitoring. Our team includes former FDA reviewers and military health system veterans who ensure your study meets every regulatory nuance.

• Site identification & feasibility
• Project management (PMP‑certified leads)
• Risk‑based monitoring & central monitoring
• Adaptive trial design support

Data Management & Biostatistics

From CDISC‑compliant database builds to advanced analytics and DSMB support, our statisticians deliver clarity. We specialize in handling sensitive government data within secure environments.

Regulatory Affairs & Government Compliance

Our regulatory strategists have shepherded products through FDA, EMA, and DoD regulatory pathways. We maintain deep expertise in federal acquisition regulations (FAR/DFAR) and 8(a) sole‑source contracting.

Pharmacovigilance & Drug Safety

Global safety database, 24/7 case processing, aggregate reporting, and signal detection — fully compliant with ICH E2E and federal pharmacovigilance requirements.

Central Laboratory & Biomarker Services

CAP/CLIA‑certified labs with integrated logistics and real‑time data portal. Specialized in biospecimen management for large government cohort studies.