Abiozen’s CRO360™ division delivers customized clinical trial strategies aligned to the specific objectives, regulatory expectations, and operational demands of each trial phase. Our framework ensures scientific integrity, risk mitigation, and accelerated progression from early research to post-marketing success.

Phase I – Safety and Dose Escalation
In Phase I trials, our focus is on evaluating safety, tolerability, and pharmacokinetics in a small cohort of healthy volunteers or patients. We implement adaptive trial designs and rigorous monitoring protocols to protect participants and rapidly identify optimal dose ranges. These studies are executed with high precision to generate reliable early-phase data that informs downstream development.

Phase II – Efficacy and Dose Optimization
Phase II studies are designed to explore therapeutic efficacy while refining dose regimens. We utilize biomarker-driven endpoints and stratified patient cohorts to enhance response predictability. Our data-driven approach ensures robust protocol design and early detection of signals that support go/no-go decisions for Phase III transition.

Phase III – Large-Scale Validation
In Phase III, we execute multicenter, statistically powered trials to confirm efficacy, monitor adverse events, and validate safety across diverse populations. Real-time data analytics and central monitoring systems ensure data quality and regulatory alignment. These pivotal trials form the backbone of submission packages to global authorities such as the FDA and EMA.

Phase IV – Post-Market Surveillance and Real-World Evidence
Following regulatory approval, our Phase IV programs focus on long-term safety, effectiveness, and pharmacovigilance. We generate real-world evidence (RWE) to support additional indications, label expansions, and health economics outcomes. These insights are critical for lifecycle management, market access, and ongoing regulatory engagement.

Abiozen’s structured, phase-wise methodology—drawing inspiration from Curia Global’s oncology-focused trial design—ensures operational continuity, data reliability, and a streamlined path to commercialization across every therapeutic area.