Advantage eClinical

Among the greatest challenges we share as clinical researchers is developing an ecosystem to generate the highest quality data for our studies. We learn by experience that high quality data comes from a combination of technology, clinical expertise and teamwork. We realize that getting data collection systems set-up fast and efficiently speeds trials and reduces study costs. And we require customizable systems that are fast, nimble and user-friendly to fully realize the power of using data to make decisions during trials, such as in adaptive designs.

Emmes developed Advantage eClinical with those thoughts in mind. Our single-platform solution enables you to use one system for electronic data capture, study design, safety data and reporting, subject enrollment and randomization, risk-based monitoring, source data verification, patient reported outcomes, MedDRA/WHO coding, and specimen shipment tracking. Using a single platform eases the burden on investigators and sites, as well as clients in managing data and eliminates the need for reconciliation. What’s more, Advantage eClinical empowers you to combine speed of setup and data collection with flexibility to customize the system for your specific needs.

Advantage eClinical data collection and management platform is 21 CFR Part 11, EU GMP Annex 11, GDPR and HIPAA compliant

Advantage eClinical was co-developed by IT and data management professionals, biostatisticians, clinicians, medical officers, programmers and analysts at Emmes. Together, we’ve created a system based on the needs of clinicians. Using Advantage eClinical, we work with you from protocol development through regulatory submission to enhance data quality and speed study timelines.

Advantage eClinical is 21 CFR Part 11, EU GMP Annex 11, GDPR, HIPAA adherent.

Advantage eClinical data collection and management platform is 21 CFR Part 11, EU GMP Annex 11, GDPR and HIPAA compliant

Advantage eClinical by the numbers

  • 1,000 Phase I-IV clinical trials in 60+ countries
  • 730K patients
  • 22K clinical trial sites
  • 22M eCRF pages
  • 200M data points captured
  • 50M data points verified

Advantage eClinical key features and benefits

  • 21 CFR Part 11 & Section 508 adherent
  • Fast & user-friendly for site personnel to efficiently enter data
  • Compatible with all major browsers and devices
  • Role-based access control and workflow
  • Single Sign-On
  • Real-time audit trails, edit checks, and email alerts
  • Query automation and risk-based monitoring
  • Integrated safety database, ePRO, and SDV modules
  • Integrated specimen and shipment tracking via GlobalTrace
  • Support for CDISC formats and large-scale imaging

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

Emmes Advantage eClinical manages study design, enrollment, randomization, CRF, safety, ePRO, lab specimens, and MEDRA drug coding

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

Emmes Advantage eClinical empowers clinicians to create and manage randomization, study arms, visits, forms, and fields

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
Contact Us

Advantage eClinical Leaders

Hemang Maniar

Hemang Maniar

Chief Information Officer
Noble Shore

Noble Shore

Associate Vice President
Jodi DeStefano

Jodi DeStefano

Senior Product Manager
Chandrapal Mandloi

Chandrapal Mandloi

Software Architect
Omid Neyzari

Omid Neyzari

Software Engineering Manager
Miebi Stuekerjuergen

Miebi Stuekerjuergen

Software Quality Assurance Manager
Karunakar Reddy

Karunakar Reddy

Director IT