CDR System (Cognitive Testing)
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Platform · Cloud SaaSCompany source
Company profile
About Signant Health
Signant Health is a leading provider of clinical trial technology and services, specializing in generating high-quality, reliable clinical trial data for pharmaceutical sponsors, CROs, and biotech companies worldwide. With over 30 years of experience and thousands of trials supported, Signant delivers comprehensive eClinical solutions under its SmartSignals platform, including electronic Clinical Outcome Assessment (eCOA/ePRO), Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), supply chain software, patient engagement tools, eConsent, telemedicine, and clinical data analytics. The company's approach combines advanced technology with deep scientific and clinical expertise, supported by over 50 in-house scientists and clinicians who provide protocol design guidance and measurement strategy consultation. Signant's solutions address the full spectrum of clinical trial needs, from early-stage protocol development through regulatory submission, with particular strength in complex clinical outcome assessments, electronic clinician ratings, rater training and qualification, and digital health technologies. The company has supported clinical trials associated with 25% of novel drug approvals across FDA and EMA from 2021-2024. Signant serves diverse therapeutic areas including CNS, oncology, pediatrics, psychedelics, and vaccines, with solutions tailored for Phase I trials, medical devices, decentralized clinical trials, and both emerging biopharma and established pharmaceutical companies. The company provides global operational infrastructure including 24/7 multilingual helpdesk support, device provisioning and logistics, translation services, and comprehensive project management to ensure seamless trial execution across any geography.
Company description Signant Health official website
Primary marketClinical Trials & Research
Commercial modelCommercial information available on request
Company presenceOfficial website
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01 · Operating footprint
Where the Company operates
Company-profile context for clinical focus, customers, deployment, integration, milestones, and partnerships.
Clinical focus
- CNS disorders
- Oncology
- Pediatric conditions
- Psychedelics research
- Respiratory conditions
- Vaccines
Who it serves
- Biotech companies
- CROs
- Emerging biopharma
- Medical device companies
- Pharmaceutical sponsors
Deployment & integration
Cloud Saas deployment with recorded integration context.
Recorded integration context: API marketplace for third-party integrations, Card networks and banks for payments, EHR systems, SSO via ID Portal.
Geographic context
MarketsEurope · Global · International markets with device shipment capabilities · Japan (Japanese language support indicated) · United States
Company sourceOfficial website
Company milestones
Platform expansion
Supported 25% of novel drug approvals across FDA and EMA from 2021-2024
Partnerships
Recorded partners
- Card networks and banks
- Global logistics partners
- Scale and license holders for clinical outcome assessments
02 · Flagship portfolio
Products, workflows, and platform capabilities
Selected source-backed Company products and the available commercial context.
COA Data Analytics
Analytics and insights for clinical outcome assessment data
Platform · Cloud SaaSCompany source
Data Aggregation and Intelligence
Clinical data hub with study oversight and RBQM capabilities
Platform · Cloud SaaSCompany source
eCOA (Electronic Clinical Outcome Assessment)
Patient-reported outcomes and COA data collection with patient-centered technology
Platform · Cloud SaaSCompany source
eConsent
Electronic informed consent for clinical trial participants
Platform · Cloud SaaSCompany source
EDC (Electronic Data Capture)
Comprehensive EDC solution with 30-year track record for modern clinical trials
Platform · Cloud SaaSCompany source
Electronic Clinician Ratings
Rater training, qualification, and central ratings for clinical trials
Platform · Cloud SaaSCompany source
Patient Engagement App
Mobile app for patient engagement in clinical trials
Software · Cloud SaaSCompany source
RTSM (Randomization and Trial Supply Management)
Clinical IP management and randomization system for global trials
Platform · Cloud SaaSCompany source
03 · Research intelligence
Research Intelligence evidence
Publications, preprints, clinical validation, and regulatory records in Evidence Position order.
Evidence position
Publications, clinical validation, and regulatory records connected to this Company appear here.
Research
Publications & preprints
Calibrated clinical judgment in psychiatric drug trials: Beyond psychometric scales.Journal of psychiatric research · Jun 15, 2026
Sensor-based digital health technologies to capture endpoints in recent clinical trials: a scoping review.NPJ digital medicine · Apr 3, 2026
Patient-Reported Outcomes to Inform Tolerability Characterization in Cancer Trials: A Critical Perspective on Unresolved Methodological Issues.Cancer control : journal of the Moffitt Cancer Center · Jan 1, 2026
Methodological challenges in outcomes research for early-trials for implementation of new therapies in neuropediatric rare diseases.Orphanet journal of rare diseases · Oct 17, 2025
Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screen.Therapeutic innovation & regulatory science · Sep 1, 2025
Replicating and extending the reliability, criterion validity, and treatment sensitivity of the shortened PANSS for pediatric trials.European child & adolescent psychiatry · Sep 1, 2025
Clinical validation
Clinical-trial records
Efficacy and Safety of Mepolizumab in Adults With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)/ Eosinophilic Chronic Rhinosinusitis (ECRS)NCT04607005 · Sponsor · COMPLETED
Regulatory
Regulatory records
No linked records are currently available.
04 · Company-reported outcomes
Outcomes and case studies
Company-reported outcomes and customer stories are distinct from linked Research Intelligence evidence.
33% faster eCOA launch timelines
Through intelligent automation technologies
25% of novel drug approvals
FDA and EMA approvals from 2021-2024 associated with Signant-supported trials
Thousands of trials supported
Over 30 years of operation
Hundreds of drug approvals secured
Regulatory submissions supported
Global Respiratory Trial
Streamlining global respiratory trial complexities with robust data capture strategy
05 · Leadership
Leadership team
Leadership profiles and professional links from the current Company record.
No active leadership profiles are currently listed.
06 · Company updates
Updates from Signant Health
Recent articles published on Signant Health's official website.
FDA's New CGM Data Guidance: What Clinical Trial Sponsors Need to Know
Read on Signant HealthKCCQ and MVPA in Heart Failure Trials
Read on Signant HealthFrom sample-based to signal-based: the evolution of 100% clinical quality review
Read on Signant HealthReframing Obesity Care | Signant Health
Read on Signant HealthCognitive assessment in Parkinson’s disease | Signant Health
Read on Signant Health07 · HAIC coverage
Coverage and analysis
Health AI Central reporting that mentions this Company.
No HAIC coverage is currently linked to this Company.
08 · Official presence
Company sources and channels
Curated official destinations from the active Company record.
09 · Market pathway
Additional Companies in this Market
Other active Companies in the same market, selected alphabetically from the HAIC directory.
Market context
Clinical Trials & Research
Companies using AI to optimize clinical trial design, accelerate patient recruitment, match patients to trials, predict trial outcomes, or improve clinical research efficiency. Includes patient enrollment and screening platforms, AI-powered trial matching, and tools that reduce the time and cost of bringing new treatments to market.
Explore the full market directory or compare this Company with additional active profiles.
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10 · Pro research
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Expanded Company research is in development.
Health AI Central Pro · Coming Soon
Deeper Company research is coming soon.
Pro Research will introduce expanded technical context, linked evidence analysis, and comparative Company research.
Linked research, clinical, and regulatory source pathways.
Expanded product, deployment, integration, and partnership research.
Record-level provenance and review context.