Quality product development
At CMAX, our expert team work cohesively to support our national and international clients accelerate their product development in Phase I-II studies, as well as later phase studies, delivering exceptional service.
Our experienced Clinical Project Managers and Study Coordinators welcome the challenges of modern complex clinical trial protocols.
Studies we have conducted include:
- Complex adaptive FTIH protocols, including single ascending dose, multiple ascending doses (SAD/MAD)
- Food-effect studies
- Bioequivalence/bioavailability/pivotal PK studies
- Pharmacokinetic/pharmacodynamics (PK/PD) studies
- Vaccine, including therapeutic vaccine studies
- Gene therapy, GMO
- Safety and tolerability – skin irritation/sensitization protocols
- Devices studies
- Inhalation studies
- Ethnopharmacology studies
Our purpose-built 50-bed clinical trial unit is a fully-secure, self-contained facility which is operational 24 hours / 7 days per week.
The unit has all the facilities and equipment one would expect from an early phase clinical trials, including ambulatory cardiac telemetry monitoring, on-site processing laboratory and secure pharmacy room, emergency call bells and procedures, in addition to a range of other specialist equipment.
CMAX is able to draw on a range of expertise within Adelaide BioMed City, which includes Adelaide’s flagship public hospital, two universities, research institutes and imaging providers, to make even the most complex protocol feasible. Our partnerships provide access to wide range of diagnostic laboratory testing and biomarker testing.
We operate in a wide range of therapeutic areas and have experience in most routes of study drug administration and a variety of investigational products, encompassing new chemical entities (NCE), small molecules, monoclonal antibodies, vaccines, gene therapy and biosimilar studies.
CMAX have conducted studies across the following therapeutic areas:
- Allergy / Respiratory
- Infectious Diseases
The CMAX recruitment team enrol healthy volunteer and patient populations through its established recruitment networks and active volunteer database. Study participants are enrolled from Adelaide and South Australia, which has a stable but diverse population of over 1.7 million. CMAX’s location in the Adelaide CBD means that it is easily accessed by our volunteers, reducing barriers to participation.
CMAX’s Quality Management System is overseen by our QA department and assures our studies meet global regulatory standards, irrespective of complexity.
If you are working on a project that would benefit from CMAX's networked experience and expertise, we would love to hear from you today.