Mobius Medical Pty Ltd.
Founder-led contract research organisation (CRO) focused on clinical development and regulatory pathways for medical devices and combination products. Core services include clinical trial strategy and execution, regulatory submissions and quality systems (ISO 9001, ICH‑GCP/ISO 14155 alignment), data management and biostatistics, pre-clinical coordination, site activation across Australia, New Zealand and the USA, and post-market support including market access and reimbursement planning. The organisation has documented experience running early-phase pilot studies, pivotal multicentre interventional trials (including randomized controlled device trials), and AI-enabled diagnostic studies that supported De Novo and 510(k)/IDE regulatory pathways.
Industries
Nr. of Employees
small (1-50)
Mobius Medical Pty Ltd.
North Sydney, New South Wales, Australia, Oceania
Products
Clinical Trial Management
Service managing the planning, execution, and monitoring of clinical trials to ensure data integrity and regulatory compliance.
Electronic Data Capture (EDC) Services
Provision of electronic systems to collect, manage, and store clinical trial data digitally for improved accuracy and accessibility.
Clinical Trial Management
Service managing the planning, execution, and monitoring of clinical trials to ensure data integrity and regulatory compliance.
Electronic Data Capture (EDC) Services
Provision of electronic systems to collect, manage, and store clinical trial data digitally for improved accuracy and accessibility.
Services
Clinical Trial Strategy
Concept and feasibility analysis, clinical planning, synopsis and regulatory package preparation, IEC/IRB approvals and KOL collaboration.
Clinical Trial Execution
End-to-end operational management including site selection, monitoring, validated EDC, eTMF, safety monitoring, biostatistics and clinical investigation reports.
Regulatory and Beyond
Regulatory pathway assessment, submission support, local sponsor services, QMS implementation and independent quality assurance oversight.
Pre-clinical and Bench Testing Coordination
Coordination of bench and lab testing, small and large animal studies and cadaver labs to generate pre-clinical evidence.
Commercialisation & Market Access
Reimbursement strategy, payer research, coding and billing support, health economics and go-to-market partnerships.
Clinical Trial Strategy
Concept and feasibility analysis, clinical planning, synopsis and regulatory package preparation, IEC/IRB approvals and KOL collaboration.
Clinical Trial Execution
End-to-end operational management including site selection, monitoring, validated EDC, eTMF, safety monitoring, biostatistics and clinical investigation reports.
Regulatory and Beyond
Regulatory pathway assessment, submission support, local sponsor services, QMS implementation and independent quality assurance oversight.
Pre-clinical and Bench Testing Coordination
Coordination of bench and lab testing, small and large animal studies and cadaver labs to generate pre-clinical evidence.
Commercialisation & Market Access
Reimbursement strategy, payer research, coding and billing support, health economics and go-to-market partnerships.
Expertise Areas
- Clinical trial management for medical devices
- Randomized multicentre interventional device trials
- Pivotal trials and long-term follow-up for implantable devices
- Regulatory strategy and submissions (FDA, EMA, TGA, De Novo, 510(k), IDE)
Key Technologies
- Electronic data capture (EDC) systems
- Clinical trial management systems (CTMS) and eTMF
- AI and machine learning for diagnostic classification
- Elastic scattering spectroscopy (ESS)