Services

What We Do

Neural Outcomes Consulting Inc works with health care professionals and researchers to aid the performance of cutting edge research with state- of- the- art trial design. We specialize in oncology, neurological and musculoskeletal disease.

Clinical Research: Our experience spans the complete continuum of care, addressing direct patient care needs, translation of bench to bedside, and implementation of all aspects of clinical research.

  • Protocol Design (Trial Design)
  • Site selection
  • Endpoint development
  • Case Report Form (CRF), eCRF and documentation development

Investigation New Drug (IND) Application: Data gathered during the basic animal studies and proof of principle human studies is typically used to establish the basis of an Investigational New Drug (IND) application. This process pre-empts the initiation of a formal Phase I clinical drug trial. NOCI provides assistance to sponsors who need to submit an IND application to the FDA, by providing appropriate support for outcomes selection and use, along with available data analysis to support the use of specific assessments and endpoint design. NOCI is proud to have provided this service to ReNetX BIO, Flex Pharma, and Neuro Recovery Technologies.

Outcome Measures: With a special interest and experience in the development and use of outcome measures, we optimize any clinical study or trial with the implementation of the most appropriate outcome measures.

  • Development of new outcomes assessments
  • Refinement or modification of existing outcomes assessment
  • Clinician reported outcomes development and implementation for late stage clinical trials

Training/Education: We design and develop teaching modules for clinicians and study staff, providing training on the use and implementation of new outcomes, gold standard outcomes, treatment techniques and interventions to all members involved in the study for consistent reporting.

  • On-site clinical training for clinicians and study staff
  • Centralized training for clinicians and study staff
  • Inter-rater reliability studies for study staff (examiners)
  • Break-out sessions and investigator meetings

Medical Science Liaison (MSL): With our advanced scientific training, academic credentials, knowledge of clinical trial execution, strategic relationships and academic network, we establish and maintain peer-peer relationships with Primary Investigators, Study Teams and Key Opinion Leaders (KOL’s), at major academic hospitals, institutions and clinics. As an MSL we:

  • Work throughout a product’s lifecycle in various therapeutic areas of research
  • Ensure that products and services are utilized effectively
  • Serve as a scientific peer and resource within the academic hospitals amongst the study teams
  • Provide scientific expertise to internal colleagues at the CRO, pharmaceutical and industry level

Independent Medical Evaluations (IME):  We provide objective, independent third-party medical exams requested by insurance companies, WSIB, benefit providers, HR managers, lawyers, and employers.

We determine the cause, extent and medical treatment of work-related or other injury where liability is an issue. IME includes:

  • Development of customized and standard clinical outcomes templates to assess injury
  • Provide objective independent assessment of injury
  • Provide comprehensive and complete reporting

New Drug Application (NDA) Assistance: NOCI provides assistance with the synthesis of knowledge and data analysis to sponsors and CROs, who are applying to the Food and Drug Administration (FDA) for NDA approval. The NDA application is a formal proposal made by drug sponsors to the FDA, for approval of a new pharmaceutical for sale and marketing in the United States of America. NOCI helps to synthesized and develop the supporting documentation and evidence for the final steps required to receive NDA approval.  We are happy to be providing this service to our sponsor, DAICHI SANYKO

For Further Information about our services and fee structure, please contact us.

Portfolio of Experience

Who we’ve worked with

What We’ve Done

NEURORECOVERY TECHNOLOGIES, INC.

  • Design, Development and Implementation of Endpoint
  • Development of Educational Module to train for the Implementation of GRASSP Version 2
  • Development of teaching module and written reference manuals.
  • Provision of webex training and evaluation of assessors for site qualification

RENETX BIO

  • Provide guidance on spinal cord injury, motor and functional endpoints
  • Assist with endpoint protocol development, design and implementation
  • Provide capacity for education and training to standardize study protocol
  • Identify endpoints that will be meaningful to stakeholders

NISCI – A multicenter European Clinical Trial: THE NISCI CLINICAL TRIAL

  • Development of Educational Module to train for the Implementation of GRASSP Version 2
  • Development of a protocol specific teaching modules and written reference manuals
  • Provision of European Centralized Training and evaluation of assessors for site qualification

NISCI (Nogo-A Inhibition in acute Spinal Cord Injury) is a multicenter, multinational, placebo controlled phase-II study for the safety and preliminary efficacy of intrathecal anti-Nogo-A [NG101] in patients with acute cervical spinal cord injury.

The purpose of the NISCI trial is to test if an antibody therapy can improve motor function and quality of life of tetraplegic patients. A previous trial showed this treatment is safe and well accepted. This current trial has been approved by the National Ethics Committee and Ministry of Health for all participating trial sites.

INVIVO THERAPEUTICS: THE INSPIRE STUDY

  • Development and implementation of Clinician Reported Outcomes
  • Development of Educational Module to train for the Implementation of Clinician Reported Outcomes (ISNCSCI)
  • Development of a protocol specific ll teaching modules and written reference manuals.
  • Provision of onsite training and evaluation of assessors for site qualification

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INVIVO THERAPEUTICS: THE INSPIRE STUDY

  • Antibodies Against Nogo-A to enhance plasticity, regeneration and functional recovery after acute spinal cord injury: NISCI STUDY
  • Development of GRASSP, Modified Ashworth and SCIM III teaching modules and written reference manuals.
    • Development of all teaching materials and planning of a centralized training in Germany in partnership with the EMSCI
    • Provision of centralized onsite and webex training and evaluation of assessors for site qualification

VERTEX PHARMACEUTICALS: The SPRING Trial

  • Development of Educational Module to train for the Implementation of Clinician Reported Outcomes (ISNCSCI, GRASSP, SCIM III)
  • Development of all teaching modules and written reference manuals.
  • Provision of onsite training and evaluation of assessors for site qualification
  • Studying VX-210, an investigational therapy for acute traumatic cervical spinal cord injury requiring surgery:
  • The purpose of the SPRING Trial is to determine the efficacy and safety of an investigational therapy, VX-210, in subjects with acute traumatic cervical spinal cord injury.
  • VX-210 is applied to the spinal cord during initial decompression/stabilization surgery.
  • The VX-210 Clinical Trial will enroll about 100 patients at multiple clinical trial sites in the United States and Canada. For a list of sites enrolling, please visit ClinicalTrials.gov.

ASTERIAS BIOTHERAPEUTICS

  • Development of Educational Module to train for the Implementation of Clinician Reported Outcomes (GRASSP)
  • Development of teaching module and written reference manuals.
  • Provision of webex training and evaluation of assessors for site qualification

DAIICHI SANKYO DEVELOPMENT LTD(“DSI”): THE ENLIVEN STUDY

  • Development and Implementation of Clinician Reported Outcome
  • Identified and developed a specific Range of Motion Assessment protocol as an important secondary endpoint
  • Development of all teaching modules and written reference manuals, including reference standards, electronic data capture algorithms for data processing and the electronic Case Report Forms (CRF)
  • Study Design through development and implementation of a blinding protocol related to the ROM assessment

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DAIICHI SANKYO DEVELOPMENT LTD(“DSI”): THE ENLIVEN STUDY

Vendor Status: Consultant to DSI:

  • The Enliven Study – A Double-blind, Randomized, Placebo-controlled Phase 3 Study of Orally Administered PLX3397 in Subjects with Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)

Specific Role: Development and Implementation of Clinician Reported Outcome

  • Identified and developed a specific Range of Motion Assessment protocol as an important secondary endpoint
  • Development of all teaching modules and written reference manuals, including reference standards, electronic data capture algorithms for data processing and the electronic CRF
  • Study Design through development and implementation of a blinding protocol related to the ROM assessment

Vendor Responsibilities:

  • Collaborate with multiple vendors related to the study
  • Engagement with primary investigators and study teams at 45 sites globally to provide:
    • Support in recruiting blinded assessors
    • Provide onsite training for ROM assessment protocol
    • Evaluate and establish assessor competence at each site

ASUBIO PHARMACEUTICALS, INC ACUTE STROKE CLINICAL TRIAL

  • Assist in development of Clinician Reported Outcome (CRO), provided capacity for CRO development, item generation and reduction.

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ASUBIO PHARMACEUTICALS, INC ACUTE STROKE CLINICAL TRIAL

Vendor Status: Consultant to Asubio Pharmaceuticals

  • Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)

Specific Role: Assist in development of Clinician Reported Outcome (CRO), provided capacity for CRO development, item generation and reduction.

Development of Teaching Modules to administer CRO

STEMCELLS INC: THE PATHWAY STUDY

  • Development of Teaching Modules for Assessors administering Clinician Reported Outcomes (CRO) of material to transfer the knowledge.

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STEMCELLS INC: THE PATHWAY STUDY

Vendor Status: Consultant to StemCells Inc.

  • A Single-Blind, Randomized, Parallel Arm, Phase II Proof-of-Concept Study of the Safety and Efficacy of HuCNS-SC Transplantation in Cervical Spinal Cord Injury

Specific Role: Development of Teaching Modules for Assessors administering Clinician Reported Outcomes (CRO)

  • Develop teaching modules to train assessors to administer:
    • International Standards of Neurological Classification of SCI (ISNCSCI)
    • GRASSP Version 1.0
  • Develop Training manuals and reference documents for assessors for:
    • International Standards of Neurological Classification of SCI
    • GRASSP Version 1.0
    • Spinal Cord Independence Measure III
    • Modified Ashworth
    • eCRF development
  • Provide centralized, on-site and Webex training for the ISNCSCI and GRASSP
    • Establish competence of all assessors (evaluation) and approve for engagement in study
    • Define a remedial plan for those who require one
    • Conduct inter-rater reliability studies for all assessors (UEMS, LEMS, GRASSP)

ASUBIO PHARMACEUTICALS, INC/ DP CLINICAL

  • Develop examiner training materials and provide onsite training to centers involved in study
  • Trained 50 centers in North America and Europe in ISNCSCI and SCIM III administration
  • Establish competence among assessors involved

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ASUBIO PHARMACEUTICALS, INC/ DP CLINICAL

Vendor Status: Consultant to DP Clinical

  • Phase II randomized, placebo-controlled efficacy trial for SUN13837 in acute SCI

Specific Role: Development of SCIM III training module and onsite training for ISNCSCI and SCIM III

  • Develop examiner training materials and provide onsite training to centers involved in study
  • Trained 50 centers in North America and Europe in ISNCSCI and SCIM III administration
  • Establish competence among assessors involved

ACCORDA PHARMACEUTICAL, INC/ DP CLINICAL

  • Development of SCIM III training module and Webex Training
  • Develop examiner training materials and provide Webex training to centers involved in study
  • Trained 50 centers in North America and Europe in ISNCSCI and SCIM III administration
  • Establish competence among assessors involved
  • Consulting on use and implementation of GRASSP

Read More

ACCORDA PHARMACEUTICAL, INC/ DP CLINICAL

Vendor Status: Consultant to DP Clinical

  • Phase 2, doubleblind, randomized, placebocontrolled study to determine the safety, tolerability and potential activity of AC105 in humans

Specific Role: Development of SCIM III training module and Webex Training

  • Develop examiner training materials and provide Webex training to centers involved in study
  • Trained 50 centers in North America and Europe in ISNCSCI and SCIM III administration
  • Establish competence among assessors involved

BIOAXONE THERAPEUTIC INC.

  • Consulting on use and implementation of GRASSP in study design (endpoint determination) and development of the eCRF

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BIOAXONE THERAPEUTIC INC.

Vendor Status: Consultant to Bioaxone Therpeutic Inc.

  • Phase II Efficacy trial of Cethrin for Acute Spinal Cord Injury

Specific Role: Consulting on use and implementation of GRASSP in study design (endpoint determination) and development of the eCRF

NEUROLOGICAL HEALTH CHARITIES OF CANADA (NHCC)

  • A member of the knowledge translation team, specifically developing material to inform clinicians regarding the findings, their relevance and impact on practice.
  • Synthesis and knowledge transfer of study results for health care practitioners
  • Development of material to transfer the knowledge

Read More

NEUROLOGICAL HEALTH CHARITIES OF CANADA (NHCC)

Vendor Status: Consultant to NHCC

  • National Population Health Study of Neurological Conditions (NPHSNC), Canada

Description: First ever national study to identify status of health care provision and quality of life across the continuum of care for individuals with neurological disease, funded by the Federal Government. The purpose of this research was to inform the consumer, stakeholders regarding the impact and risks of neurological disease, and inform the health care field and policy makers about preventative measures and required changes to the model of health service delivery

Specific Role: A member of the knowledge translation team, specifically developing material to inform clinicians regarding the findings, their relevance and impact on practice.

  • Synthesis and knowledge transfer of study results for health care practitioners
  • Development of material to transfer the knowledge

Ontario SCIM III Implementation Strategy

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Ontario SCIM III Implementation Strategy

Vendor Status: Consultant to Ontario Bioinformatics SCI Strategy

  • Ontario Bioinformatics SCI Strategy project

Specific Role: Develop and Provide Education on Implementation of SCIM III in Ontario

  • A standardized methodology to educate clinicians in the administration of the SCIM III at two centres in Ontario was developed and then training was provided.
  • Follow up manuals and a training video were developed as resources for re education at the site.
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If there are any difficulties with the website, please contact us directly at

timryan@neuraloutcomes.com or skr@neuraloutcomes.com.