II
Phase 2
Dose-finding, safety, and early efficacy. Skilled in adaptive designs, biomarker-driven enrichment, and PK/PD intensive sampling.
- FIH-experienced PIs
- Adaptive & basket designs
- Intensive PK sampling rooms
Capabilities
II
Dose-finding, safety, and early efficacy. Skilled in adaptive designs, biomarker-driven enrichment, and PK/PD intensive sampling.
III
Pivotal, registration-enabling trials. Built for high enrollment volume without compromising data quality.
IV
Post-marketing surveillance, real-world evidence, and label-expansion studies in our community population.
Therapeutic areas
Each therapeutic area is led by a dedicated principal investigator with at least ten years of trial experience in the indication.
On-site infrastructure
12-lead ECG, telemetry, ambulatory BP, Holter, spirometry, DLCO
Refrigerated & ambient centrifuges, -20°C and -80°C monitored storage
Locked, temperature-controlled IP storage with 21 CFR Part 11 logging
Two private IV infusion suites with overnight observation capability
Central IRB (Advarra, WCG) and local IRB submissions, 1572s in 48h
Internal QA audits every quarter, audit-ready essential documents
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