Clinical research expertise. From design to implementation.
Neural Outcomes Consulting Inc. works with healthcare professionals and researchers to support clinical trial design and execution. We specialize in neurological research, with experience supporting oncology and musculoskeletal studies.
Specialized services. Connected expertise.
From study planning and outcome assessment to scientific communication and independent evaluation.
Clinical research
Support for clinical trial design and execution, from protocol planning to research documentation.
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NOCI's research experience spans direct patient-care considerations, translation of research into clinical practice, and implementation of clinical studies.
- Protocol and trial design
- Research site selection
- Endpoint development
- Case Report Forms (CRFs), eCRFs and related documentation
Outcome measures
Selection, development and implementation of meaningful clinical outcome assessments.
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- Development of new outcome assessments
- Refinement or modification of existing assessments
- Development and implementation of clinician-reported outcomes for late-stage clinical trials
- Selection and use of appropriate measures for the study population and objectives
IND application assistance
Assessment and endpoint expertise to support sponsors preparing Investigational New Drug applications.
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What an IND involves. The original NOCI Services page explains that data from basic animal studies and proof-of-principle human studies typically form the basis for an Investigational New Drug (IND) application. The IND process precedes initiation of a formal Phase I clinical drug trial.
NOCI's role. NOCI assists sponsors preparing IND submissions to the US Food and Drug Administration by supporting the selection and appropriate use of outcome assessments, reviewing available data and analyses that support assessment choice, and contributing to study endpoint design.
Published experience. NOCI identifies ReNetX BIO, Flex Pharma, BrainQ Technologies and NeuroRecovery Technologies (ONWARD Medical) as organizations for which it has provided IND-related assistance.
This is regulatory submission support, not a claim that NOCI approves a drug or guarantees an IND outcome.
NDA application assistance
Knowledge synthesis, data analysis and supporting documentation for New Drug Application submissions.
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What an NDA involves. A New Drug Application (NDA) is a formal proposal from a drug sponsor to the US Food and Drug Administration requesting approval to sell and market a new pharmaceutical product in the United States.
NOCI's role. NOCI assists sponsors and clinical research organizations (CROs) with knowledge synthesis, data analysis, and the preparation and development of supporting documentation and evidence for NDA submissions.
Published experience. NOCI's original page names Daiichi Sankyo Inc. and its product Turalio as an example of NDA-related assistance.
The FDA makes regulatory decisions; NOCI's service is scientific and documentation support.
Medical science liaison
Peer-to-peer scientific engagement with investigators, study teams and key opinion leaders.
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Scientific relationships and networks. NOCI's original page emphasizes the team's advanced scientific training, academic credentials, understanding of clinical trial execution, strategic relationships, and academic network. These capabilities support peer-to-peer relationships with principal investigators, study teams, and key opinion leaders at academic hospitals, institutions, and clinics.
Medical science liaison activities include:
- Working across a product's lifecycle and across therapeutic areas of research.
- Helping ensure appropriate and effective use of products and services.
- Serving as a scientific peer and resource to academic hospital investigators and study teams.
- Providing scientific expertise to internal colleagues within CROs, pharmaceutical companies, and other industry organizations.
Independent medical evaluations
Objective third-party medical assessments and comprehensive reporting for organizations requiring independent evaluation.
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NOCI describes evaluations requested by insurers, WSIB, benefit providers, HR managers, lawyers and employers, including cases involving the cause, extent or treatment of injury and disputed liability.
- Customized and standard clinical outcome templates
- Objective independent assessment of injury
- Comprehensive reporting
Supporting each stage of clinical research.
NOCI combines study design, outcome measurement, implementation and scientific expertise according to project requirements.
Design
Trial protocols, site selection and endpoint planning.
Develop
Assessments, CRFs, eCRFs and study-specific reference documentation.
Implement
Assessor preparation, standardized teaching and training across participating sites.
Support
Scientific engagement, evidence synthesis and regulatory submission assistance.
Consistent training. Confident implementation.
Standardized reference materials and clinician education support consistent use of neurological rehabilitation protocols and outcome measures. Explore in-person, live virtual and independent e-Learning options for clinical and research teams.
Who we've worked with.
Organizations and studies named in NOCI's original Services portfolio. See the featured projects and archive below for documented responsibilities.
Our work in practice.
Examples of published NOCI project responsibilities. Expand any project to see the specific work.
ONWARD Medical
Endpoint design and implementation; GRASSP Version 2 teaching modules, manuals and virtual assessor training.
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Originally listed as: ONWARD Medical Inc. (NeuroRecovery Technologies, Inc.)
- Design, development and implementation of a study endpoint.
- Development of an educational module to train clinicians in implementation of GRASSP Version 2.
- Development of teaching modules and written reference manuals.
- Provision of WebEx training and evaluation of assessors for site qualification.
NISCI clinical trial
GRASSP Version 2 study-specific education and centralized European training for research assessors.
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Study: NISCI (Nogo-A Inhibition in acute Spinal Cord Injury), a multicentre, multinational, placebo-controlled Phase II study evaluating the safety and preliminary efficacy of intrathecal anti-Nogo-A (NG101) for acute cervical spinal cord injury.
Study purpose: To determine whether an antibody therapy could improve motor function and quality of life among individuals with tetraplegia. The original description notes that an earlier trial suggested acceptable safety and tolerability and describes regulatory approvals at participating sites.
NOCI responsibilities:
- Developed an educational module for implementation of GRASSP Version 2.
- Developed protocol-specific teaching modules and written reference manuals.
- Provided European centralized training and evaluation of assessors for site qualification.
Source note: Another passage on the original page discusses NISCI-related GRASSP, Modified Ashworth and SCIM III training under a duplicated InVivo heading. That attribution requires confirmation.
Daiichi Sankyo / ENLIVEN
Range-of-motion assessment protocol, electronic documentation, blinded assessment procedures and site training.
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Vendor status: Consultant to Daiichi Sankyo Development Ltd. (DSI).
Study: ENLIVEN, a double-blind, randomized, placebo-controlled Phase III study of orally administered PLX3397 in subjects with pigmented villonodular synovitis (PVNS) or giant cell tumour of the tendon sheath (GCT-TS).
Specific role: Development and implementation of a clinician-reported outcome.
- Identified and developed a specific range-of-motion (ROM) assessment protocol as an important secondary endpoint.
- Developed teaching modules and written reference manuals, including reference standards.
- Developed electronic data capture algorithms for data processing and electronic Case Report Forms (eCRFs).
- Contributed to study design through development and implementation of a blinding protocol related to the ROM assessment.
Vendor responsibilities:
- Collaborated with multiple vendors related to the study.
- Engaged principal investigators and study teams at 45 sites globally.
- Supported recruitment of blinded assessors.
- Provided onsite training for the ROM assessment protocol.
- Evaluated and established assessor competence at each site.
Related studies: Japanese ENLIVEN (DSPL3397-A-J304) and ENLIVEN Asia are separately listed in the portfolio archive.
Ontario SCIM III strategy
Standardized SCIM III education for clinicians at two Ontario centres, including reusable training resources.
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Vendor status: Consultant to Ontario Bioinformatics SCI Strategy.
Project: Ontario Bioinformatics SCI Strategy.
Specific role: Develop and provide education on implementation of SCIM III in Ontario.
- Developed a standardized methodology to educate clinicians in administration of SCIM III at two Ontario centres.
- Provided training to clinicians at these centres.
- Created follow-up manuals and a training video as resources for future re-education.
Explore additional project work.
Selected historical projects and engagements, with published responsibilities retained in expandable entries.
Mitsubishi Tanabe Pharma — MT-3921 study
Project: Mitsubishi Tanabe Pharma, MT-3921 global study.
- Developed an educational module for implementation of GRASSP Version 2.
- Developed teaching modules and written reference manuals.
- Provided WebEx training and evaluated assessors for study-site qualification.
ReNetX BIO
- Provided guidance on spinal cord injury, motor and functional endpoints.
- Assisted with endpoint protocol development, design and implementation.
- Provided education and training capacity to standardize study protocols.
- Helped identify endpoints meaningful to stakeholders.
InVivo Therapeutics — INSPIRE study
Project: INSPIRE study.
- Developed and implemented clinician-reported outcomes.
- Developed an educational module to train assessors in implementation of clinician-reported outcomes, including ISNCSCI.
- Developed protocol-specific teaching modules and written reference manuals.
- Provided onsite training and evaluation of assessors for site qualification.
Source note: A separate section of the original site is also titled “InVivo Therapeutics: The INSPIRE Study” but refers to antibodies against Nogo-A in the NISCI study, GRASSP/Modified Ashworth/SCIM III manuals, and centralized training in Germany with EMSCI. It appears to be mislabeled in the original content, so that work is not assigned to INSPIRE without verification.
Vertex Pharmaceuticals — SPRING trial
Study: SPRING trial, investigating VX-210 for acute traumatic cervical spinal cord injury requiring surgery.
Study purpose: To evaluate the efficacy and safety of VX-210 in subjects with acute traumatic cervical spinal cord injury. The source describes VX-210 being applied to the spinal cord during initial decompression/stabilization surgery and a planned enrolment of approximately 100 patients at multiple sites in the United States and Canada. This is historical study information, not a current recruitment notice.
NOCI responsibilities:
- Developed educational modules on clinician-reported outcomes (ISNCSCI, GRASSP and SCIM III).
- Developed teaching modules and written reference manuals.
- Provided onsite training and evaluated assessors for site qualification.
Asterias Biotherapeutics
- Developed an educational module to train assessors in administration of clinician-reported outcomes (GRASSP).
- Developed a teaching module and written reference manuals.
- Provided WebEx training and evaluated assessors for study-site qualification.
StemCells Inc. — PATHWAY study
Vendor status: Consultant to StemCells Inc.
Study: PATHWAY, a single-blind, randomized, parallel-arm Phase II proof-of-concept study assessing 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.
- Developed teaching modules for International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and GRASSP Version 1.0.
- Developed assessor training manuals and reference documents for ISNCSCI, GRASSP Version 1.0, SCIM III and Modified Ashworth.
- Supported electronic Case Report Form (eCRF) development.
- Provided centralized onsite and WebEx training for ISNCSCI and GRASSP.
- Evaluated assessor competency and approved assessors for study engagement.
- Defined remedial plans for assessors needing additional support.
- Conducted inter-rater reliability studies for UEMS, LEMS and GRASSP assessments.
Asubio Pharmaceuticals — acute stroke study
Vendor status: Consultant to Asubio Pharmaceuticals.
Study: Efficacy of SUN N4057 in subjects with acute ischemic stroke and measurable penumbra on magnetic resonance imaging (MRI).
Specific role: Supported development of a clinician-reported outcome (CRO), including item generation and item reduction.
- Provided capacity for CRO development.
- Developed teaching modules to administer the CRO.
Asubio / DP Clinical — SCI study
Vendor status: Consultant to DP Clinical.
Study: Phase II randomized, placebo-controlled efficacy trial of SUN13837 in acute spinal cord injury.
Specific role: Development of SCIM III training module and onsite training for ISNCSCI and SCIM III.
- Developed examiner training materials and provided onsite education to study centres.
- Trained 50 centres in North America and Europe in ISNCSCI and SCIM III administration.
- Established competence among study assessors.
Acorda Pharmaceuticals / DP Clinical
Vendor status: Consultant to DP Clinical.
Study: Phase II double-blind, randomized, placebo-controlled study evaluating safety, tolerability and potential activity of AC105 in humans.
Specific role: SCIM III training module development and WebEx training.
- Developed examiner training materials and provided WebEx training to participating study centres.
- The original page reports training 50 centres in North America and Europe in ISNCSCI and SCIM III administration.
- Established assessor competence.
- Provided consultation on GRASSP use and implementation, as listed in the original overview.
BioAxone Therapeutic
Vendor status: Consultant to BioAxone Therapeutic Inc.
Study: Phase II efficacy trial of Cethrin for acute spinal cord injury.
Specific role: Consultation on GRASSP use and implementation in study design, including endpoint selection/determination and development of the electronic Case Report Form (eCRF).
Neurological Health Charities of Canada
Vendor status: Consultant to Neurological Health Charities Canada (NHCC).
Project: National Population Health Study of Neurological Conditions (NPHSNC), Canada.
Background: A federally funded national study examining healthcare provision and quality of life for people with neurological conditions across the care continuum. The original description says the results were intended to inform consumers and stakeholders about neurological disease impacts and risks, prevention priorities and potential health-service delivery improvements.
Specific role: Member of the knowledge translation team developing materials to communicate study findings and their implications for practice.
- Synthesized results and translated study knowledge for healthcare practitioners.
- Developed educational and knowledge-transfer materials.
Original-page attribution note — NISCI / InVivo
The original Services page repeats the heading “InVivo Therapeutics: The INSPIRE Study,” but one of those blocks explicitly describes the NISCI anti-Nogo-A study. Because the heading and study text conflict, the content is preserved below without assigning the work to INSPIRE:
- Anti-Nogo-A antibody research intended to enhance plasticity, regeneration and functional recovery following acute spinal cord injury.
- GRASSP, Modified Ashworth and SCIM III teaching modules and written reference manuals.
- Development of teaching materials and planning of centralized training in Germany in partnership with EMSCI.
- Centralized onsite and WebEx training, with evaluation of assessors for site qualification.
Attribution requires confirmation: These responsibilities appear in the source under a duplicate InVivo heading while explicitly naming NISCI.
AO Spine — IN-TWIN Study
Original portfolio entry: AO Spine IN-TWIN Study.
The original NOCI Services page lists this study under its portfolio of experience. A following section is misnested and contains Daiichi Sankyo ENLIVEN responsibilities rather than a separately attributable IN-TWIN role. Those ENLIVEN responsibilities are preserved under the ENLIVEN project, not attributed to AO Spine.
Responsibility attribution: Additional IN-TWIN-specific details were not clearly supplied by the indexed original page. NOCI should confirm the original study description before adding project-specific claims.
Helius Medical Inc.
Original portfolio entry: Helius Medical Inc.
Helius Medical appears in NOCI's original “Who we've worked with” list. The indexed original page does not provide a clearly attributed study background, vendor role, or breakdown of NOCI's responsibilities for this engagement.
Responsibility attribution: Listed as published experience only; details can be added when confirmed by NOCI.
Japanese ENLIVEN — DSPL3397-A-J304
Distinct original study entry: “The Japanese ENLIVEN Study: DSPL3397-A-J304 Study.”
Portfolio relationship: This is listed separately beneath the Daiichi Sankyo ENLIVEN family of studies in the original NOCI portfolio. It is not merged with the global ENLIVEN study or with ENLIVEN Asia.
Study-specific background and NOCI responsibilities: The indexed original Services page provides the name and study identifier but does not provide a separate project narrative or responsibility breakdown specifically for this Japanese study. The global ENLIVEN roles, including 45-site training, are not automatically attributed to this entry.
ENLIVEN Asia
Distinct original study entry: “The ENLIVEN Asia Study.”
Portfolio relationship: NOCI's original portfolio lists ENLIVEN Asia separately from both the global ENLIVEN study and the Japanese ENLIVEN DSPL3397-A-J304 study.
Study-specific background and NOCI responsibilities: The indexed original Services page does not supply additional details specifically attributed to ENLIVEN Asia. The detailed global ENLIVEN responsibilities remain in the separate Daiichi Sankyo / ENLIVEN expandable panel and are not copied here as though verified for this Asian study.
These descriptions refer to published historical work. They do not imply that the studies are ongoing or currently enrolling.
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Contact our team about clinical research services, outcome measures, scientific consultation, project scope and fees.
