Molecule2Market (M2M) is a boutique, full-service Contract Research Organisation (CRO) with deep expertise in designing and delivering medical device clinical trials alongside pharmaceutical and diagnostic studies. Our team understands the unique scientific, regulatory, and operational challenges facing MedTech innovators, from first-in-human feasibility studies through to pivotal trials required for market approval.

With an average of over 20 years’ experience, our senior team members bring hands-on knowledge of both ISO 14155 standards and regional regulatory requirements, ensuring trials are conducted to the highest quality and compliance standards. We have successfully managed device trials across multiple therapeutic areas, including endocrinology, cardiology, surgical, ophthalmological, diagnostics, and digital health technologies.

M2M’s footprint spans all major cities of Australia, and New Zealand and the USA, allowing us to run efficient, multicentre studies that access diverse patient populations. Australia, in particular, offers significant advantages for device development, including streamlined ethics/regulatory pathways, generous R&D incentives, and internationally recognised data accepted by the FDA and EMA.

As a boutique CRO, we pride ourselves on our agility, responsiveness, and personal approach. Each team member is carefully chosen not only for their technical expertise but also for their ability to collaborate closely with sponsors, investigators, and sites — creating strong partnerships that accelerate study delivery.

M2M is also a proud member of AICROS (the Association of International Contract Research Organizations), an alliance of well-established, regionally based CROs working together to provide high-quality clinical research services on a global scale. Through this network, we can seamlessly extend support to Europe, Asia, and beyond, giving MedTech companies a single, trusted partner for global development programs.

Whether you are running an early feasibility device study, a large-scale pivotal trial, or seeking guidance on operational strategy, M2M brings the right blend of scientific insight, operational rigour, and global reach to support your success.

Why work with us

Why Choose M2M?

1. Deep Medical Device Expertise – Proven track record running feasibility and pivotal device trials under ISO 14155 and regional regulatory frameworks.
2. Senior, Hands-On Team – Average 20+ years’ experience; every project is led by seasoned professionals, not passed down to juniors.
3. Agile & Personalised Service – Boutique approach means clients get direct attention, quick decisions, and tailored solutions.
4. Global Reach, Local Insight – Coverage across Australia, New Zealand, and the USA, plus global support through AICROS.
5. Regulatory Advantage in Australia – Fast ethics/regulatory approvals, FDA/EMA-accepted data, and access to generous R&D incentives.
6. Broad Therapeutic Expertise – Experience across neurology, cardiology, orthopaedics, diagnostics, oncology, rare disease, and digital health.
7. Quality & Compliance Assured – Robust QMS, audit-ready systems, and consistent adherence to ICH GCP, FDA, EMA, and TGA standards.
8. Collaborative Culture – Hand-picked team chosen for expertise and ability to build trusted partnerships with sponsors, investigators, and sites.
9. Efficient Study Delivery – Strong investigator/site relationships and targeted recruitment strategies accelerate timelines.
10. Alliance Power – Membership in AICROS provides seamless access to reliable CRO partners worldwide.