Advantage eClinical Technology Platform Details

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Advantage eClinical EDC

  • Dynamic visit/form scheduling
  • Paginated eCRFs with document and image attachments
  • Download or print individual CRFs or entire subject booklets
  • Real-time edit checks
  • Query initiation and tracking
  • Automated initiation and resolution of queries
  • Data quality reports
  • Lock/unlock individual eCRFs or entire study database
  • PI attestation with e-signature
  • Real-time data listings
  • Image adjudication
  • Import data from Lab, EMR, or other systems
  • Integrated safety database
  • Real-time email alerts
  • Export data in CSV or CDISC ODM
  • SDTM data available via mapping module

Advantage eClinical Enrollment and Randomization

  • Registration for screening
  • Integrates with EDC to determine enrollment eligibility from screening data/lab results
  • Document inclusion/exclusion criteria met/not met
  • Enroll/Randomize eligible subjects
  • Supports double/triple blinded studies, adaptive or block designs, and open label studies
  • Automatically creates an ePRO account during enrollment
  • Integrates with GlobalTrace and EDC to provide kit tracking/assignment (IRT) capabilities
  • Real-time site activation
  • Duplicate enrollment detection

Advantage eClinical ePRO

  • Supports surveys, diary cards, memory aids, and validated instruments
  • Pagination by question/group of questions, auto-advance capabilities
  • BYO device, supports for all major browsers
  • Multi-language support
  • Password self-service or clinical coordinator can reset password
  • Email reminders to improve subject compliance
  • Subject dashboard to can show/hide forms by status or # days past due
  • Integrates with EDC for compliance tracking and optional clinical review of ePRO data

Advantage eClinical Monitoring

  • Integrate with EDC for real-time determination of SDV requirements via EDC integration
  • Risk-based monitoring (RBM) engine to determine risk group of each subject
  • Monitor primary/secondary endpoints or randomly select forms, visits, fields per risk group
  • CRA dashboard to track progress and monitoring visits
  • Query initiation and tracking
  • Intelligence based automated initiation and resolution of queries

Advantage eClinical MedDRA / WHO Drug Coding

  • Role based access and workflow
  • Automated and manual coding capabilities
  • Automated batch coding using proprietary algorithms
  • Integrated multi-step review and approval
  • Review/reclassification of coding decisions
  • Support for multiple discrete data sets
  • Support for multiple versions of dictionary and upcoding

Advantage eClinical Study Designer

  • Create study arms, visits, forms, and fields
  • Clone from eCRF Library
  • eCRF preview mode
  • Set randomization parameters

Advantage eClinical Global Specimen Tracking

  • Scan, track, and manage specimens
  • Aliquot and pooling capabilities
  • Integrate with major carriers for real-time shipment tracking
  • Email alerts
  • Customizable shipment manifests
  • Inventory reporting
  • Supports blinded labs

Advantage eClinical Safety

  • Multi-page SAE forms with role-based access
  • Document and image attachments with role-based access
  • Integration with EDC and MedDRA/ WHO Drug coding modules
  • Real-time email alerts
  • Query initiation and tracking
  • Support for MedWatch/CIOMS