Mobius provides operational support services across Australia, New Zealand, and the United States to strengthen site performance and improve trial continuity.
Our clinician-led, site-facing approach ensures that investigators, coordinators, and clinical staff are well-supported and aligned with protocol execution.
We help reduce site burden and support protocol fidelity through:
Seamless integration of study personnel into site workflows
Flexible delivery models including remote and decentralised support
Consistent communication channels between sponsor, site, and CRO
Our biometrics services are purpose-built to support the data integrity and regulatory requirements of both early-phase and pivotal trials. From database setup to final analysis, we ensure high-quality, audit-ready data is available throughout the trial lifecycle.
We ensure excellence in biometrics delivery through:
End-to-end data validation and traceability across platforms
Standardised statistical outputs aligned with regulatory expectations
Scalable systems that support both single-region and multinational studies
Our team specialises in managing complex clinical pathways for novel medical technologies with integrated services spanning regulatory, site support, data, and market access.
Let’s discuss how we can support your device from feasibility through to commercial success.
Mobius supports sponsors in navigating TGA, FDA, and ethics committee processes with regulatory strategies tailored to study design, device classification, and regional requirements. We provide direct support for document authoring, pathway selection, and submission coordination across Australia, New Zealand, and the United States.
We streamline the regulatory process by:
Aligning early-stage planning with long-term approval strategy
Managing submission timelines and stakeholder engagement
Ensuring compliance with local and global authority expectations
Mobius embeds quality and safety oversight across the entire trial lifecycle, guided by an ISO 9001-certified quality management system and clinician-led monitoring processes. Our approach supports compliance with GCP, audit readiness, and continuous protocol integrity.
Our quality and safety framework includes:
Ongoing monitoring and documentation of compliance activities
Centralised oversight of safety signal reporting and escalation
Defined procedures for audit response and corrective action
We support sponsors in preparing for regulatory approval, reimbursement, and post-market success with a focus on connecting clinical data to real-world adoption.
Our commercialisation services are informed by experience across both early-stage planning and market launch readiness.
We help bridge clinical outcomes and commercial strategy by:
Structuring evidence packages for reimbursement and payer engagement
Mapping stakeholders and planning market access timelines
Aligning post-trial planning with regulatory and economic requirements
Comprehensive clinical trial management services in the United States, Australia, and New Zealand
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