Capabilities
Built for the full arc of evidence — from Phase 2 through Phase 4.
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
III
Phase 3
Pivotal, registration-enabling trials. Built for high enrollment volume without compromising data quality.
— Multi-arm randomized studies
— Central & local lab workflows
— Risk-based monitoring ready
IV
Phase 4
Post-marketing surveillance, real-world evidence, and label-expansion studies in our community population.
— Registry & observational
— PROs and digital endpoints
— Long-term follow-up cohorts
Therapeutic areas
Where we go deep.
Each therapeutic area is led by a dedicated principal investigator with at least ten years of trial experience in the indication.
01
Vaccines
· Influenza, RSV, mRNA platforms
· Adult & pediatric cohorts
· Healthy volunteer recruitment
02
Cardiometabolic
· Type 2 diabetes & GLP-1s
· NASH / MASH biopsy studies
· Lipid lowering & PCSK9
03
Pulmonology
· COPD exacerbation prevention
· Severe & eosinophilic asthma
· IPF & chronic cough
04
Metabolic
· Obesity pharmacotherapy
· Thyroid & adrenal disorders
· Rare metabolic indications
05
General Medicine
· Type 2 diabetes & GLP-1s
· NASH / MASH biopsy studies
· Lipid lowering & PCSK9
On-site infrastructure
Equipped for the protocols sponsors actually run.
Imaging & cardiac
12-lead ECG, telemetry, ambulatory BP, Holter, spirometry, DLCO
Sample handling
Refrigerated & ambient centrifuges, -20°C and -80°C monitored storage
Pharmacy
Locked, temperature-controlled IP storage with 21 CFR Part 11 logging
Infusion
Two private IV infusion suites with overnight observation capability
Regulatory
Central IRB (Advarra, WCG) and local IRB submissions, 1572s in 48h
Quality
Internal QA audits every quarter, audit-ready essential documents
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