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