Signant Health
Last Updated
Overview
Signant Health provides a unified eClinical platform where EDC, eCOA, eConsent, and TeleVisits share one database and login, reducing the need for back-end integrations. Although complex workflows may require additional staff attention, the platform remains a practical choice for sponsors and contract research organizations managing clinical trials.
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Starting Price
Custom
Signant Health Specifications
- Appointment Management/Scheduling
- Lab Integrations
- Mobile App
- Telemedicine
Signant Health Features
Electronic Data Capture (EDC)
Signant Health’s EDC enables clinical teams to collect and manage study data through configurable, no-code workflows. It supports direct data capture, lab data integration, automated medical coding, remote source data verification (SDV), and risk-based monitoring. Users can configure complex studies using built-in eCRFs, edit checks, and custom functions while making mid-study changes with site-level versioning.
Electronic Clinician Ratings
Signant Health’s Rater Station® digitizes clinician-reported outcome (ClinRO) assessments with pre-set workflows, on-screen guidance, automated scoring validation, and customizable edit checks. The software helps prevent incomplete data and scoring errors while maintaining audit trails. It also supports secure audio/video capture, quality monitoring, self-service reporting, and API integrations for reviewing assessment data.
Randomization And Trial Supply Management
The software offers configurable randomization and trial supply management for controlling patient assignments and investigational product distribution. It uses algorithms to direct medication based on study needs, optimize expiry dates, and reduce overages. Teams can also track direct-to-patient supplies, monitor study KPIs, access near-real-time data through APIs, and generate role-based audit trail reports.
Clinical Supply Chain
The clinical supply chain feature enables teams to forecast, plan, produce, and distribute investigational products from a centralized system. Users can track inventory levels, product genealogy, and quality release status while maintaining end-to-end traceability. Built-in forecasting tools help determine production requirements, identify potential medication shortages, and maintain audit-ready supply records throughout clinical trials.
eConsent
The eConsent feature enables participants to review and sign informed consent forms digitally for on-site, virtual, or hybrid studies. Teams can manage ICF versions, re-consenting, and time-stamped audit trails while tracking consent progress through reporting dashboards. Interactive options also support video and audio content, comprehension tests, and question flagging to help participants understand study requirements.
Data Aggregation And Intelligence
This capability brings clinical data from multiple sources into a centralized environment for analysis and oversight. Teams can ingest, standardize, and aggregate data while automating cleaning, reconciliation, and validation. The platform also provides a unified view of study data for medical reviews, patient monitoring, risk-based quality management (RBQM), and custom analytics.
Pros And Cons of Signant Health
Pros
Reduces manual effort across clinical data workflows
Improves accuracy of clinician-reported study assessments
Minimizes medication waste across clinical trial supplies
Cons
Tablet workflows may require initial familiarization
Technical issues may occasionally affect data collection
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Frequently Asked Questions
Can clinicians capture study data during Signant Health video consultations?
Yes, Signant Health enables direct clinical data capture alongside video consultations through its clinician interface. This allows clinicians to record relevant study data while conducting remote patient visits within the telemedicine workflow.
Can Signant Health deliver patient reminders in local languages?
Yes, Signant Health’s Patient Engagement app provides behavioral reminders in local languages. It also includes visit schedules and visit-by-visit information to keep patients informed about upcoming study activities and participation requirements.
Does Signant Health include its own EDC, or is a separate EDC needed?
Signant Health’s SmartSignals Unified Platform includes its own EDC at its core. eCOA, eConsent, TeleVisit, and randomization are optional add-on modules that run on the same platform and database, so separate back-end integrations are not required.
Does Signant Health require back-end integrations between its eClinical modules?
No, Signant Health builds EDC and its add-on modules on a single database using one configurable designer. This removes the need to create back-end integrations between the platform’s individual modules.
Does Signant Health support wearable devices for continuous patient monitoring?
Yes, Signant Health provides Digital Health Technologies for continuous real-world monitoring through wearable sensor integration. This capability became part of its offering following the acquisition of Ametris and ActiGraph.
How long does it take to set up Signant Health?
Signant Health says studies using its Unified Platform can typically be implemented in four to six weeks. For eCOA, Signant states that designing and building the system takes approximately six to eight weeks, with additional time potentially needed for instrument approvals and user acceptance testing.
Can patients use their own devices with Signant Health eCOA?
Yes, Signant Health’s Unified Platform eCOA supports patients using their own devices (BYOD) or Signant-provided devices. Its responsive design works across smartphones, tablets, laptops, and desktops, provided they have internet access. Other Signant eCOA solutions support offline use.
What types of outcome assessments does Signant Health eCOA support?
Signant Health supports electronic patient-reported outcomes (ePRO), clinician-reported outcomes (eClinRO), observer-reported outcomes (eObsRO), and performance outcomes (ePerfO). Its eCOA library contains more than 50 instruments and supports PROMIS computerized adaptive testing (CAT).
Does Signant Health support decentralized clinical trials?
Yes. Signant Health supports decentralized and hybrid trials with remote eConsent, at-home eCOA, BYOD or provisioned devices, TeleVisits, remote clinician ratings, and other remote data-collection capabilities.