Sequence WebEAS – Clinical Event/Endpoint Adjudication Platform

Sequence WebEAS, a Clinical Event/Endpoint Adjudication Solution, is a web-based solution allowing distributed PVG and committee personnel to participate in the adjudication process in an efficient, robust, secure, and easy-to-use manner. The system features role configurable dashboards, intuitive PVG and committee member workflow, search engine, powerful edit checks/data validation and many other features to increase compliance and greatly improve process efficiency. Highly configurable and standards-based, Sequence WebEAS can be easily integrated with many different EDC systems. All Sequence Platform modules run seamlessly integrated or standalone and are 21 CFR Part 11 compliant and fully validated.

Platform Versions

WebEAS Advanced:

  • Complex/customized concordance and adjudication workflow
  • All features: SMQ, WebFXP, Dicom, EDC integration, MACE, Meeting Management module, etc.
  • Fully customizable to eliminate the need for out-of-system workarounds and loss of efficiency

WebEAS Standard:

  • Configurable adjudication and concordance workflow
  • Features: SMQ, WebFXP, EDC integration, MACE

WebEAS Lite:

  • Simple adjudication workflow and features
  • Limited event counts
  • Price Point designed to replace paper studies

Advantages

  • Eliminates the rigidity of other adjudication Platforms
  • WebFXP Site Portal: Facilitates Document Exchange and communication between Sites and Safety groups
  • Robust PDF Redaction and Processing Utility
  • Compilation of Dossier – Automated
  • Flexible Reporting
  • SMQs for consistent Event Identification
  • Streamlines Workflow Variations between protocols
  • CEC Meeting and Notes Management Module
  • Committee Member payment tracking
  • Access to Ancillary Event/Subject Data
  • Enhanced SMQ Support
  • Extensive Reporting and Metrics
  • Enhanced Dashboards and User Reporting

Features & Benefits

  • Greatly increases efficiency for PVG, Committee, and Bio-statistician personnel
  • Streamlines source document collection and automates dossier creation and bookmarking
  • Eliminates adjudication backlog by efficiently capturing accurate and pertinent information needed to classify events
  • Develop custom classification forms for each protocol
  • Provides escalation workflow for Adjudication Committee discordance
  • Improves compliance & ensures adherence to procedures for unbiased review of clinical data
  • Increases consistency of event adjudication with a structured adjudication process
  • Web-Enabled, very user-friendly interface, flexible branding
  • Minimal training required
  • Integrates with EDC, Safety Systems, CMTS & Other Electronic Data Sources
  • Compiles Medical Records, CRFs & Relevant Event Data into a single repository
  • Manage Meetings, Notes, attendees and all ancillary data for review history
  • Easily review eCRF data, source documents, dossiers, classification forms, comments, and event histories in a centralized location.
  • CDISC / CDASH Compliant
  • Payment tracking reports

Support and Training

  • Quick and efficient user training
  • In-person training also available at sponsor facilities
  • Zero client requirements except browser
  • Remote training available
  • Technical support and dedicated 800 number per study
  • Many levels of help desk and support options available

Security

  • Role and workflow-based security
  • Customizable event notifications
  • Configurable workflow to fit customer’s organization
  • Configurable down to the field level
  • Configurable actions by role or user

Data / Hosting

  • All data will be hosted on a validated, secure server located in a hardened, redundant hosting facility
  • Full business continuity and disaster recovery functions provided
  • All data will be backed up on a nightly basis both locally and to a different geographic location for redundancy
  • 24/7/365 Performance and fault monitoring
  • All files will be the client’s property and transferred upon request

Sequence WebFXP - Included with WebEAS

Sequence WebFXP is a web-based solution allowing sponsors, CROs, sites and vendors to easily and securely exchange communications, queries and documents. The system features role configurable dashboards, intuitive workflow, search engine, archives and many other features to increase compliance and greatly improve process efficiency. Highly configurable and standards-based, Sequence WebFXP can operate stand-alone or be easily integrated with other clinical platforms and systems.

Features & Benefits

  • Securely exchange any electronic document
  • Eliminate the need for email from document requests, queries and site communications
  • Dashboard views of document and query requests, status, and fulfillment
  • Built-in redaction tool. Send electronic requests for source documentation directly from other systems.  Sites/sponsors/CROs can redact, and upload requested documents directly to an event Provides escalation workflow for urgent requests
  • Improves compliance & ensures adherence to security standards
  • Completely browser based, no software to install
  • Web-Enabled, user-friendly interface, with flexible branding
  • Minimal training required
  • Integrates with EDC, Safety Systems, CTMS & Other Electronic Data Sources
  • Easily review source documents, requests, queries, comments, and communication history in a centralized location
  • 21 CRF Part 11 Compliant
  • CDISC / CDASH standards-based
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Sequence DataConverge - Included with WebEAS

DataConverge provides portal-based module for reporting, dashboards and data exports. Users can build and manage their own reports or utilize out-of-the-box reports provided with implementation of other Sequence modules.

Features & Benefits

  • Custom configurable monitoring dashboards per user
  • Ad Hoc Building of Reports by users
  • 20+ included reports and report templates
  • Easy to use drag and drop report generator
  • Flexible Metrics report capability
  • Reporting feature integrates with Excel
  • Allow non-technical users to easily export data
  • Dashboards for critical study and performance data
  • Create graphs, charts, cross tabs, etc.
  • Distribution of reports can be scheduled, real-time, push/pull, and on-demand
  • Allow/deny access for clients, sites, etc.