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Neuroscience Trials Australia

Heidelberg, Victoria, AU

Neuroscience Trials Australia is an Australian-based, not-for-profit contract research organization (CRO) specializing in neuroscience clinical research. We undertake work with and for our neuroscience Australian and New Zealand colleagues and thus have extensive experience and knowledge in the neuroscience arena.

We will deliver your project in a cost-effective and timely manner.

Therapeutic areas of expertise include epilepsy, stroke and stroke-related conditions, multiple sclerosis, Alzheimer’s disease (AD)/cognitive disease studies, mental health and associated conditions, Parkinson’s disease, spinal cord injuries, Huntington’s disease, neurosurgery, pain, neuromuscular disease and migraine.

The Florey Institute of Neuroscience and Mental Health, “The Florey”, is now the largest brain research institute in the southern hemisphere.

Our state of the art facilities over three campuses in Melbourne... Show more »

Neuroscience Trials Australia is an Australian-based, not-for-profit contract research organization (CRO) specializing in neuroscience clinical research. We undertake work with and for our neuroscience Australian and New Zealand colleagues and thus have extensive experience and knowledge in the neuroscience arena.

We will deliver your project in a cost-effective and timely manner.

Therapeutic areas of expertise include epilepsy, stroke and stroke-related conditions, multiple sclerosis, Alzheimer’s disease (AD)/cognitive disease studies, mental health and associated conditions, Parkinson’s disease, spinal cord injuries, Huntington’s disease, neurosurgery, pain, neuromuscular disease and migraine.

The Florey Institute of Neuroscience and Mental Health, “The Florey”, is now the largest brain research institute in the southern hemisphere.

Our state of the art facilities over three campuses in Melbourne Australia, include platforms such as laboratories (including diagnostic laboratories for the assessment of amyloid and tau proteins), pre-clinical work, imaging facilities (PET, MRI, CT etc) and translational research.

Our staff has global management expertise in all phases of clinical research including studies sponsored by pharmaceutical and device companies, the biotechnology industry, granting bodies (such as the NIH or Australian equivalent NHMRC), collaborative groups, institutions and Investigator-initiated studies.

Our clients include:

  • Pharmaceutical and biotechnology industry (local and international)
  • Government granting bodies (such as the NIH or Australian equivalent NHMRC)
  • Collaborative group projects
  • Non-government bodies
  • Investigator-driven projects

We have fast access to:

  • Therapeutic disease groups
  • Key opinion leaders
  • Quality, experienced sites
  • Project Directors
  • Project Managers
  • Clinical Researcher Associates (CRAs)
  • Clinical Trial Administrators (CTAs)
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Neuroscience Trials Australia has not listed any services.

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Clinical Development Strategy
Price on request

Safety is paramount during all phases of clinical research.

We can provide the following medical monitoring services:

  • Medical support to sites for study protocol interpretation and subject medical management
  • Medical review and assessment of serious adverse event reports
  • Preparation of serious adverse event... Show more »

Safety is paramount during all phases of clinical research.

We can provide the following medical monitoring services:

  • Medical support to sites for study protocol interpretation and subject medical management
  • Medical review and assessment of serious adverse event reports
  • Preparation of serious adverse event narratives for regulatory reporting or inclusion in clinical study reports
  • Assistance with, and participation in, Data Safety Monitoring Boards
  • Timely receipt, processing and communication of initial serious adverse event reports and follow-up to case closure
  • Safety reporting in compliance with local regulatory requirements
  • Preparation and distribution of investigator notification letters.
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Biostatistical Analysis
Price on request

We offer a wide range of services including:

  • Study design
  • Sample size calculations / power analyses
  • Interim analyses and statistical monitoring
  • Writing/reviewing statistical sections of protocols
  • Randomisation schedules
  • Programming of tables, listings and figures
  • Biostatistical analyses
  • Design of ‘case... Show more »

We offer a wide range of services including:

  • Study design
  • Sample size calculations / power analyses
  • Interim analyses and statistical monitoring
  • Writing/reviewing statistical sections of protocols
  • Randomisation schedules
  • Programming of tables, listings and figures
  • Biostatistical analyses
  • Design of ‘case report forms’
  • Design of database and entry screen and maintenance
  • Data Management Plans
  • Specification of data structures and data handling procedures/validation
  • Validation/Consistency check programming.
« Show less
Data Management
Price on request

We offer a wide range of services including:

  • Study design
  • Sample size calculations / power analyses
  • Interim analyses and statistical monitoring
  • Writing/reviewing statistical sections of protocols
  • Randomisation schedules
  • Programming of tables, listings and figures
  • Biostatistical analyses
  • Design of ‘case... Show more »

We offer a wide range of services including:

  • Study design
  • Sample size calculations / power analyses
  • Interim analyses and statistical monitoring
  • Writing/reviewing statistical sections of protocols
  • Randomisation schedules
  • Programming of tables, listings and figures
  • Biostatistical analyses
  • Design of ‘case report forms’
  • Design of database and entry screen and maintenance
  • Data Management Plans
  • Specification of data structures and data handling procedures/validation
  • Validation/Consistency check programming.
« Show less
Medical Writing
Price on request

We provide a comprehensive array of clinical trial-related medical writing services in accordance with applicable regulations and guidelines such as:

  • Investigators’ brochures
  • Study protocols
  • Participant information forms
  • ‘Case report form’ completion guidelines
  • Clinical study reports
  • Policies
  • Standard operating procedures.

We provide a comprehensive array of clinical trial-related medical writing services in accordance with applicable regulations and guidelines such as:

  • Investigators’ brochures
  • Study protocols
  • Participant information forms
  • ‘Case report form’ completion guidelines
  • Clinical study reports
  • Policies
  • Standard operating procedures.
« Show less
Clinical Trial Monitoring
Price on request

Our staff has a thorough knowledge of local regulations and ‘good clinical practice’ (GCP) processes. We adapt easily to our customers’ needs. We are totally flexible and can follow your procedures or you can ask us to employ our own – it’s up to you.

We can assist you with:

  • Phases I to IV (in Australia or globally)
    -... Show more »

Our staff has a thorough knowledge of local regulations and ‘good clinical practice’ (GCP) processes. We adapt easily to our customers’ needs. We are totally flexible and can follow your procedures or you can ask us to employ our own – it’s up to you.

We can assist you with:

  • Phases I to IV (in Australia or globally)
  • Site feasibility and identification
  • ‘Investigator’ and ‘monitor’ meeting preparation and set-up
  • All types of monitoring visits including site selection, Initiation, routine and study-closure visits
  • Local regulatory submissions
  • Obtaining local HREC/EC/IRB approvals
  • Site management
  • Good clinical practice (GCP) training
  • Monitoring, communication and study-plan generation and implementation
  • Query resolution
  • Blinded and unblinded investigational
  • Product accountability
  • Subject recruitment plans and implementation.
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Project Management
Price on request

Our project managers are committed to ensure milestones are reached and timelines met.
The project manager serves as your primary point of contact and has direct responsibility for all aspects of the clinical trial. They are fully versed on local regulations and will assist with regulatory requirements when setting-up a study... Show more »

Our project managers are committed to ensure milestones are reached and timelines met.
The project manager serves as your primary point of contact and has direct responsibility for all aspects of the clinical trial. They are fully versed on local regulations and will assist with regulatory requirements when setting-up a study in Australia or in other parts of the world. Our project managers can provide guidance on labelling requirements, import permits and local indemnification and insurance issues.

Neuroscience Trials Australia is a registered enterprise in Australia with the Therapeutic Goods Administration (TGA) and therefore can act as your representative locally.

We can provide you with the following:

  • Development, guidance and management of your clinical development program
  • Management of assigned project teams
  • Project status reports and newsletters
  • Management of project milestones and deliverables
  • Project, monitoring, communication and recruitment plan generation and implementation
  • Local regulatory advice
  • Management of third party vendors
  • Management of site/investigator payments and tracking.
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Feasibility Studies
Price on request

We routinely produce feasibility reports on site availability, potential recruitment and local treatment standards. We can also produce more complex reports when required. With our direct access to the therapeutic disease groups, key trial sites and key opinion leaders, we can produce feasibility reports within very short time frames.

We routinely produce feasibility reports on site availability, potential recruitment and local treatment standards. We can also produce more complex reports when required. With our direct access to the therapeutic disease groups, key trial sites and key opinion leaders, we can produce feasibility reports within very short time frames.

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Project and Process Management
Price on request
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Marketing, Communication & Graphic Design Services
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Editorial and Writing Services
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Business Development Consulting
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Process Consulting
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Clinical Research
Price on request
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Clinical Trials, Consulting, and Management
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Computational Modeling
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Data Services
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Biostatistics & Bioinformatics
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