Our Services

ClinTab
Clinical Trials

Neurocognitive assessments, Behavioral - Psychiatric Measures (BPMs) and trial management.

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C Minds
Clinical Practice

Utilization of trial management methods across a wide spectrum of the healthcare system.

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Cares
Clinical Research

Clinical Testing and Diagnostics for Multi-site research projects.

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Technology Development Services

NeuroComp has more than 25 years of experience in the design, development and clinical evaluation of hardware and software-based health care devices and systems.
 

Medical Device Development

Targeted application areas include monitoring of regional cerebrovascular dynamics in adults and neonates. Application to the heart required development of a new approach to cardiac output estimation, based on extracted waveshape features, as well as pathology-specific waveform classification. Nearly all of these systems have utilized various embedded high speed processors and ancillary electronics (e.g. display controllers, wireless communications). Portable device design includes the first ultra-thin tablet PC for paperless data collection in clinical trials and related research, in collaboration with the Epson corporation for the Japanese market.

Medical Device services and expertise encompass:

  • high level system design
  • clinical use case analysis
  • cost/benefit analysis - market analysis
  • technology development management
  • critical component analysis and selection
  • production cost estimation
  • regulatory compliance (e.g. electronic emissions, validation, etc.)
  • contractor vetting
  • clinical trial design
  • collaborator recruitment


Additional relevant experience includes designing for compliance with: 1) International Electrotechnical Commission (IEC) 1000-4-2; 1000-4-5;1000-4-8;1000-4-9; CISPR 11; FCC Class B; UL 544 and AAMI-SCL, 2) Health Insurance Portability and Accountability Act (HIPAA) of 1996 and 3) 21 CFR Part 11 for electronic health records and electronic signatures.

Previous development and consulting work includes:

  • high performance electroenchephalographs (up to 84 channels)
  • multichannel bioimpedance for cardiac and brain monitoring
  • intraoperative monitors
  • positron emission tomography (PET)
  • magnetic resonance imaging (MRI).
 

Software System Development

Software design and development experience encompasses concept-to-clinical-validation. Services include:

  • Assessment and roadmap development
  • Front end development: UXI and GUI design
  • Coding and documentation, including validation matrix
  • Quality assurance
  • Regulatory compliance

Previous work includes:

  • development of the CMINDS system for wide-ranging cognitive and behavioral assessment
  • computerization of the Illness Management and Recovery (IMR) program in collaboration with originators at Dartmouth University
  • development of a web-based obesity management program for the Veterans Administration health care system
  • remote cognitive and behavioral assessment
  • computerization of the Alzheimer’s Disease Assessment Scale (ADAS), the gold standard in clinical trials of new treatments
  • computerization of the MATRICS assessment battery for the evaluation of new treatments for schizophrenia and related conditions
 

Clinical Trials

Clinical trial implementation services include initial study planning design, staff training of all systems, remote technical support, secure data transmission and management, full compliance with regulatory requirements (e.g., 21 CFR Part 11, HIPAA, GCP, etc.), and delivery of detailed study end-point reports including comprehensive audit trails and complete study database files in CDISC-compliant SQL, SAS, Oracle, or ASCII formats.
 

Clinical Practice

The clinical utility that our systems offer significant capabilities to clinical practitioners and health maintenance organizations (e.g. ACOs) across the healthcare system.

Electronic Data Capture of a wide range of neurocognitive, behavioral and psychiatric assessments, at the point of patient contact significantly streamlines the data and report acquisition for integration into existing EMR systems.