CLINICAL TRIAL SERVICES


Having emerged from a unique academic neurology and neuroimaging environment at the Brain and Mind Centre (BMC) in Sydney, Australia, SNAC has in-house expertise in a broad array of neuroimaging techniques applicable to both pharmaceutical industry-driven clinical trials and investigator-initiated studies.

 

Central Reading for Phase 2-4 Clinical Trials


Multiple Sclerosis Clinical Trials

SNAC has a particular focus on Multiple Sclerosis (MS) clinical trials. We provide a regulatory-compliant central MRI reading service for MS clinical trials investigating the efficacy of disease modifying therapies.  SNAC offers a standardised battery of lesion activity and brain atrophy outcome measures, and customised solutions for studies utilising advanced imaging techniques such as diffusion imaging and magnetisation transfer imaging. 

Recently, SNAC has developed a tailored, multimodal central reading solution for Phase 2 clinical trials of emerging remyelinating therapies. Our turnkey solution incorporates central reading for MRI, mfVEP, OCT, and LCVA, as well as advice on trial design, technical training and manuals, and data management. 

For further information on Multiple Sclerosis, please visit MS Research Australia

 

Other Diseases

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

 

The SNAC Advantage

SNAC’s computerised systems are CFR 21 Part 11 compliant and adhere to all relevant US, European and Australian regulatory requirements. Our staff have rigorous technical, regulatory and GCP training. All analyses, record-keeping and archiving are subject to strict quality assurance and are regulated by SNAC standard operating procedures. Validated computer systems are central to our operations.

While imaging analysis is our core business, SNAC provides a full suite of imaging-related clinical trial services, including professional advice on study design and protocol, site MRI harmonisation, provision of site-specific MRI technical manuals and a semi-automated web-portal upload facility, dummy run analysis and site certification, and data analysis and archiving.

SNAC is closely affiliated with the Brain and Mind Centre’s MS Clinic and the BMC MS Clinical Trials Unit, providing our staff with unparalleled insights into the requirements of individual study sites. We strive to provide second to none service to sites, sponsors and researchers alike.

 

Central MRI Reading for Collaborative Investigator-Initiated Studies


SNAC also provides 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 improved understanding of drug effects and their applications, enhanced clinical practice and patient care. We also conduct our own clinical research, often involving the development and testing of novel imaging biomarkers that may later be implemented into clinical trials for the pharmaceutical industry.

 

Remyelination Therapy Trials



SNAC is redefining Phase 2 clinical trials for emerging remyelinating therapies for Multiple Sclerosis (MS) with a multimodal, turnkey central reading solution

    • Regulatory-compliant central reading services for mfVEP, MRI, OCT and LCVA

    • Advice on clinical trial design (scientific and logistic)

    • Provision of technical personnel training and manuals

    • Ensuring data standardisation and quality control

    • Access to state-of-the-art mfVEP equipment for seamless deployment to sites

 

SNAC offers a unique, multimodal approach to testing remyelination in both acute and chronic MS lesions. Our remyelination biomarker platform has been validated with both clinical research and Phase 2 clinical trials.

SNAC’s solution utilises the visual system as a platform to provide accurate measures of remyelination. This method is proven to be reliable, as the visual pathways are:

    • Highly susceptible to damage in MS

    • 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)

 

Complete central reading service for remyelination trials – our measurement techniques:

Multifocal Visual Evoked Potential (mfVEP)

Measures the electrical signal generated at the primary visual cortex in response to visual stimulation. mfVEP technology is recorded using multiple independently stimulated areas of the visual field, resulting in highly accurate measurements of signal latency.


Advanced Magnetic Resonance Imaging (MRI) Techniques

Diffusion MRI: Radial diffusivity (RD) can reflect the structural integrity of axonal membranes such as myelin, and is particularly suited to analysis of coherent fibre tracts such as the optic pathways.

Magnetisation Transfer Imaging (MTR): Measures the exchange of magnetisation between the bound pool of protons and the mobile proton pool.

Myelin Water Imaging (MWI): SNAC deploys state-of-the-art, dedicated myelin imaging techniques for multisite, multi-scanner clinical trials.


Optical Coherence Tomography (OCT)

By measuring the thickness of the retinal nerve fibre layer, OCT assists in identifying suitable populations for remyelination trials.


Low Contrast Visual Acuity (LCVA)

As demyelination worsens, so too does Low Contrast Visual Acuity. As such, LCVA can be a functional biomarker of remyelination.