Sequence WebEAS

Sequence WebEAS is a Clinical Event Committee (CEC) solution developed by CISYS LifeSciences for managing clinical endpoint adjudication in clinical trials. It is designed for investigator sites, sponsors, CROs, data managers, and CEC members, consolidating clinical event management into a single system. The platform tracks each phase of the adjudication process, from initial data collection and de-identification through dossier aggregation, committee review, and final management.

WebEAS holds ISO 27001 certification, providing a defined standard for information security and compliance in the handling of sensitive clinical data.

Core Workflow Capabilities

• Supports a structured concordance and adjudication workflow for handling and resolving complex adjudication tasks.
• Provides end-to-end visibility across all phases of the adjudication process, from data collection to committee review.
• Includes an integrated WebFXP Site Portal to facilitate document exchange and communication between investigator sites and safety groups.
• Offers PVG (Pharmacovigilance) and committee member dashboards designed for decision-making and task management.

Reporting and Data Access

• Provides reporting and metrics tools to give stakeholders access to data relevant to adjudication outcomes and process oversight.
• Supports accurate data submission through validation mechanisms and edit checks applied to Classification Forms.
• Implements Standardized Medical Queries (SMQ) to support consistent and standardized identification of clinical events.

Additional Features

• Customization: Workflows can be tailored to specific organizational or study requirements to accommodate diverse business processes.
• Search and Retrieval: A search engine supports navigation through large datasets for retrieval of relevant information.
• Automated Dossier Compilation: Automates the compilation of dossiers to reduce manual effort in document management.
• CEC Notes Management: A dedicated module supports the organization and management of Committee Meeting Notes.
• Validation and Edit Checks: Data integrity mechanisms are applied to ensure accuracy within Classification Forms.

WebEAS is positioned as an integrated system intended to support the full adjudication lifecycle within clinical trials, with security compliance backed by ISO 27001 certification and portal-based collaboration tools for site and safety group coordination.