Clinical Trial Services

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Complete imaging solutions for your clinical trial needs

At SNAC, we offer a full suite of regulatory-compliant imaging-related services tailored to meet your clinical trial needs. SNAC has broad neuroimaging analytics capability, with particular expertise in Multiple Sclerosis (MS) clinical trials. Our central MRI reading service is your full-suite solution for investigating the efficacy and outcomes of disease modifying therapies.

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Engage with SNAC experts

We deliver a unique combination of in-house expertise in neuroscience, imaging science, clinical trials, and clinical medicine (neurology and radiology). Closely affiliated and co-located with the MS Clinic and MS Clinical Trials Unit at the Brain and Mind Centre in Sydney, we have unparalleled insights into the requirements of individual study sites, clinical practice and research needs.

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Regulatory compliance

SNAC’s in-house regulatory team and certified quality management and technical systems ensure commitment to all relevant local and international privacy and regulatory frameworks. Our systems are CFR 21 Part 11 compliant, and we are fully ISO9001 and ISO13485 certified.

Expert central reading services: ensuring the success of your clinical trials.

Trial Set-Up
  • Expert advice on study design and imaging protocols
  • Provision of site-specific MRI technical manuals
  • Compliant and secure web-portal scan upload facility
Dummy-run and Site Certification
  • Site collaboration and support to ensure MRI exam success
  • Site certification upon approved dummy run
  • Harmonisation of MRI protocols across sites
Study Management
  • Quality inspection and routine tracking of all subject scans
  • Professional and fast communication with sites and sponsor
  • Secure and compliant record-keeping practices
  • Data analysis and archiving
Reporting
  • Routine progress reporting to the Sponsor
  • Timely and accurate reporting of final datasets to statistical vendors and Sponsors
  • Reproducibility and traceability of data to all sources
Quality Assurance
  • Commitment to the highest standards and ethics
  • Strict adherence to standards of applicable regulatory standards
  • Certified internal QMS and audit system
  • Cooperation with any external and/or health authority regulatory audits

A multimodal turnkey central reading solution for Phase 2 remyelination clinical trials.

SNAC is redefining Phase 2 clinical trials of emerging remyelinating therapies for MS. We offer a unique, multimodal approach for testing remyelination in both acute and chronic MS lesions. Specifically, we utilise the visual system as a platform to provide accurate measures of remyelination that have been validated with both clinical research and Phase 2 clinical trials. The visual pathways are highly susceptible to damage in MS; and are accessible to in-vivo structural and functional measurements, including Multifocal Visual Evoked Potential (mfVEP), Magnetic Resonance Imaging (MRI), Optical Coherence Tomography (OCT), and Low Contrast Visual Acuity (LCVA).

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Clinical trials for other diseases

SNAC also provide central MRI and CT reading for clinical trials involving other neurological diseases apart from MS. This includes dedicated services for cerebrovascular and neurodegenerative disease treatment clinical trials.

Collaborate with us

In addition, SNAC run central MRI reading for independent and collaborative clinical research and Investigator Initiated Studies, including studies involving predictive modelling of patient outcomes and extended monitoring of existing therapies. The results of these studies support an improved understanding of drug effects and their applications, plus enhanced clinical practice and patient care. At SNAC, we offer a full suite of regulatory-compliant imaging-related services tailored to meet your clinical trial needs. With a particular focus on MS clinical trials, our central MRI reading service is your solution to investigate the efficacy of disease-modifying therapies.

Sydney Neuroimaging Analysis Center (SNAC) has been an extraordinary partner in our clinical plans for our lead asset. When we considered Australia for our clinical trial work in neurodegenerative disease, it was quickly apparent that SNAC was the right partner. We’ve been incredibly grateful for the support we’ve received from every team member at SNAC; the SNAC team members consistently provide a level of professionalism and solid collaboration in the rigorous clinical framework required for pharmaceutical clinical drug development. Clene looks forward to further partnership with SNAC.

— Rob Etherington , President & CEO , Clene Nanomedicine

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