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CRO360™ Services

Accelerating Clinical Research with Precision, Compliance, and Global Reach

Abiozen’s CRO360™ division is redefining the future of clinical research through a fully integrated, end-to-end service model that empowers pharmaceutical innovation. From Phase I trials to post-market surveillance, we manage every stage with therapeutic precision, global regulatory alignment, and an unwavering commitment to patient safety. Backed by world-class infrastructure and strategic partnerships across key markets, CRO360™ offers scalable solutions tailored to your study’s complexity—ensuring faster approvals, higher data integrity, and reduced development risks. Partner with us to streamline your clinical pathway and bring life-changing therapies to market with confidence.

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decentralized clinical trial technology

Comprehensive CRO360™ Solutions

Accelerating Every Stage of Clinical Research with Global Precision

Clinical Trial Management

Abiozen delivers full-spectrum clinical trial management from Phase I to Phase IV with precision, speed, and compliance. Our team ensures ethical execution and regulatory alignment, backed by global operations across North America, Europe, and Asia-Pacific. Leveraging adaptive trial designs, real-time data analytics, and AI-powered patient recruitment, we optimize study outcomes while minimizing risk. Our hybrid monitoring model integrates remote and on-site oversight for improved data integrity and patient engagement. This comprehensive model ensures faster trial progression and higher success rates for market approval.

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Regulatory Support and Medical Writing

Our regulatory affairs and medical writing teams offer a seamless path from preclinical submissions to global market approvals. With over 50 successful IND, NDA, and ANDA filings, we bring unparalleled expertise in navigating FDA, EMA, DCGI, and MHRA regulatory landscapes. Our ICH-GCP-compliant documents—including CSRs, protocols, and informed consent forms—are tailored to meet international scrutiny. Proactive tracking of global regulatory changes ensures submission readiness and market alignment. This strategic support accelerates approvals and reduces time-to-market across multiple geographies.

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Therapeutic Expertise and Clinical Track Record

Abiozen offers proven clinical success across oncology, neurology, endocrinology, cardiology, ophthalmology, and infectious diseases. We bring deep therapeutic knowledge and operational excellence to each trial, utilizing cutting-edge diagnostics, imaging, and digital health tools. With over 20 oncology studies and pioneering work in CNS gene therapies, our team drives breakthroughs in complex indications. Our approach combines scientific rigor with patient-centric design, ensuring trials deliver clinically meaningful data. This domain depth enhances trust and accelerates innovation for our global partners.

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Global Reach and Site Network

Our extensive global network includes 300+ research institutions across the U.S., Europe, and Asia-Pacific, enabling rapid site activation and diverse patient enrollment. We prioritize geographic and demographic inclusivity to ensure representative trial data for global regulatory acceptance. Our relationships with top investigators and KOLs streamline site feasibility, selection, and execution. This infrastructure supports high-performing studies across a range of therapeutic areas, enhancing trial robustness. With strategic placement and deep clinical collaborations, we maximize both speed and quality in trial delivery.

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Phase-Wise Clinical Trial Management

We customize our approach to meet the unique goals and compliance standards of each clinical trial phase. Phase I trials focus on safety and pharmacokinetics, while Phase II optimizes efficacy using biomarkers and adaptive protocols. Phase III involves large-scale validation with real-time adverse event monitoring, and Phase IV ensures long-term efficacy through post-marketing surveillance. Our structured methodology is informed by global benchmarks, ensuring smooth transitions and data consistency across phases. This ensures faster approvals and reduced development risks at every stage.

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Advanced Decentralized Trials and Real-World Evidence

Abiozen leads in deploying decentralized clinical trials and real-world evidence collection to enhance access, retention, and data quality. Our DCTs leverage wearable tech, telemedicine, and virtual monitoring to minimize patient burden and boost engagement—raising recruitment by up to 25%. Post-approval, our RWE programs validate therapeutic value and support lifecycle extensions across global markets. These innovations align with industry best practices, ensuring trial continuity and robust regulatory support. Together, DCTs and RWE position your product for both scientific and commercial success.

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Post-Market Surveillance and Regulatory Submissions

Our lifecycle management services ensure patient safety and sustained product viability well beyond clinical trials. We provide 24/7 pharmacovigilance with global adverse event tracking, compliant with evolving regional mandates. Our experts handle complex regulatory submissions for new indications and markets, facilitating market expansion and commercial longevity. We also support reformulations and strategic geographic entries to maximize product lifecycle profitability. With end-to-end vigilance and proactive filings, we safeguard both patient outcomes and your brand’s global footprint.

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Expertise across the entire drug development lifecycle

IND Enabling Services

Accelerate regulatory filings with expert IND strategies that ensure speed without compromising quality.

Analytical Testing

Comprehensive analytical support delivering purity, potency, and regulatory-ready data.

Process Development

Resolve early-stage challenges with scalable, validation-ready process design.

Clinical Trial Material Production

GMP-compliant CTM manufacturing with full aseptic processing and flexible batch sizes.

Clinical Supply & Logistics

Global distribution with real-time tracking and packaging tailored to trial protocols.

Trial Management & Biostatistics

Adaptive trial execution with real-time data and regulatory-grade statistical insights.

Commercial Scale Manufacturing

Seamless scale-up to high-volume production with automated sterile filling lines.

Technology Transfer

Validated, risk-mitigated process transfer ensuring global compliance and consistency.

Packaging & Serialization

End-to-end packaging with global serialization and multilingual compliance solutions.

Generic API Manufacturing

High-quality, scalable API production with regulatory-aligned synthesis protocols.

Intermediates and RSMs

Reliable supply of key intermediates and starting materials with global reach and control.

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CRO360 Services

Strategic Market Expansion and Product Lifecycle Management

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CRO360 Services

Expert Regulatory Filings and Market Authorization Solutions

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CRO360 Services

Real-Time Safety Monitoring & Global Pharmacovigilance Compliance

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CRO360 Services

Strategic Market Expansion and Product Lifecycle Management

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CRO360 Services

Expert Regulatory Filings and Market Authorization Solutions

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

Two colleagues in a meeting room discussing financial charts and graphs on a laptop and paper.
CRO360 Services

Strategic Market Expansion and Product Lifecycle Management

property and compliance solutions for seamless market entry processes for superior purity and stability. global demand. absence of microbial contamination, essential for injectable products compliance with ICH Q3C guidelines, ensuring safety and purity residual moisture levels below 1%, critical for long-term stability. for HPAPIs, equipped with decontamination protocols and waste

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