Sequence WebEAS - Clinical Event Adjudication

Sequence WebEAS is web-based which allows distributed PVG and committee personnel to participate in the Clinical Event Adjudication process in a proficient, secure, and easy-to-use manner. The EAS system features role configurable dashboards, intuitive PVG and committee member workflows, search engine browsers, 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 also be easily integrated with many different EDC systems.


Advantages

  • Greatly increases efficiency for PVG personnel, committee members, biostatician & site personnel
  • Streamlines the source document collection process & avoids adjudication backlog
  • Integrates with EDC, safety systems, CMTS & other electronic data sources
  • Develops escalation processes for adjudication committee disagreements
  • Improves compliance & ensures blinding of Personal Health Information (PHI), for unbiased review of clinical data
  • Increases consistency of event evaluation with a structured & consistent adjudication process


Features & Benefits

  • Greatly increases efficiency for PVG, committee, and bio-  statistician personnel
  •  Streamlines source document collection and dossier  creation
  •  Eliminates adjudication backlog by efficiently capturing  accurate and pertinent information needed to classify  events
  •  Provides escalation processes for adjudication committee  disagreements
  •  Improves compliance & ensures blinding of Personal Health   Information (PHI) for unbiased review of clinical data
  •  Increases consistency of event adjudication with a  structured adjudication process
  • Web-enabled, user friendly interface
  •  Minimal training required
  •  Integrates with EDC, safety systems, CTMS & other electronic data sources
  •  Compiles medical records, CRFs, and relevant event data into a single repository
  •  Custom classification forms for each protocol
  •  Easily review eCRF data, source documents, dossiers,  classification forms, comments, and event histories in a  centralized location.
  •  CDISC / CDASH compliant
  •  Flexible branding


Reporting

  • Custom configurable monitoring dashboards per user
  • Ad Hoc building of reports capability
  • Flexible metrics report capability
  • Reporting feature integrates with Excel
  • Data tables transposed and downloadable as a ZIP file
  • Real-time reporting and data downloads
  • 20+ included reports and report templates
  • Easily create customizable user reports
  • Reporting feature integrates with SAS


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