At Abiozen, our CRO360™ Clinical Trial Management services are engineered to streamline the clinical development lifecycle—from first-in-human studies to post-marketing surveillance. Our global reach, AI-powered patient engagement strategies, and hybrid monitoring capabilities ensure that every trial meets the highest standards of scientific integrity, operational efficiency, and regulatory compliance. With over 300 research partnerships and deep therapeutic expertise, we manage complexity with confidence—accelerating study timelines and enhancing data quality across every phase of development.

Full-Spectrum Trial Lifecycle (Phase I–IV)
We offer comprehensive management for Phase I through Phase IV clinical trials, delivering seamless transitions across each stage. Our adaptive trial designs and risk-based monitoring strategies safeguard patient safety while increasing operational agility. Early-phase studies are conducted under rigorous safety protocols, while Phase II and III trials leverage biomarker-driven endpoints for optimal dosing and efficacy. Our Phase IV programs focus on real-world data and pharmacovigilance, supporting market expansion and lifecycle optimization.

Advanced Data Management and Biostatistics
Data integrity is the foundation of regulatory success. Our clinical data management solutions integrate electronic data capture (EDC), real-time monitoring dashboards, and audit-ready systems. We apply advanced biostatistical modeling to deliver actionable insights for interim analyses, protocol amendments, and final study reports. Our in-house statisticians are trained to align outputs with FDA and EMA expectations, ensuring that every statistical deliverable supports timely regulatory submissions.

Global Site Feasibility and Strategic Selection
We maintain a vetted network of over 300 clinical research sites globally, enabling rapid site activation and optimized trial performance. Our site selection process is driven by therapeutic alignment, enrollment history, and regulatory landscape, ensuring both speed and accuracy in study startup. We also assess investigator expertise, site infrastructure, and demographic suitability to enhance patient access and geographic diversity in trial populations.

AI-Powered Patient Recruitment and Retention
Accelerating enrollment is critical to trial success. Using predictive analytics and AI-driven modeling, we identify high-potential recruitment zones and patient profiles to reduce recruitment time by up to 30%. Our retention programs emphasize patient-centric communication, multilingual digital engagement, and concierge services to ensure continuity throughout the trial. This data-informed strategy enhances diversity, compliance, and overall trial integrity.

Hybrid Remote and On-Site Monitoring
Our monitoring model is built for flexibility and resilience, combining virtual oversight with in-person visits. Leveraging wearable technologies, ePRO tools, and secure telemedicine platforms, we maintain data fidelity and compliance regardless of trial location. This approach supports decentralized trial models and enhances the patient experience, particularly for rare disease or mobility-constrained populations, while maintaining ICH-GCP standards.