Sequence WebFormX

Sequence WebFormX is a configurable electronic form generation and management solution developed by CISYS LifeSciences for clinical research. It is designed to serve sponsors, contract research organizations (CROs), and investigator sites, supporting the design, deployment, and management of electronic forms aligned with specific study protocols, patient populations, and regulatory requirements. The platform integrates with the broader Sequence suite, connecting form operations with trial functions such as patient eligibility, endpoint adjudication, medical coding, and document exchange.

WebFormX includes AI-powered advanced learning algorithms, dynamic logic, and automated in-form validations to reduce data entry errors at the point of capture. It is compliant with 21 CFR Part 11 and supports CDISC/CDASH standards, and is backed by ISO 27001 certification for information security management.

Core Form and Workflow Capabilities

• Programmable in-form validation and edit checks that enforce data integrity as users complete forms, catching issues before they reach downstream systems.
• Fully customizable workflows that can mirror operational processes from data entry through review, approval, and export, with support for multiple user roles and step-based automation.
• Smart form templates that can be created once and reused across common procedures or recurring studies, with the ability to customize as needed for individual studies.
• Mobile-responsive, device-agnostic interface supporting form completion and review on desktop, tablet, or smartphone.
• Configurable workflows down to the field level, with configurable actions by role or individual user.

Search, Reporting, and Communication

• Robust search and filtering engine for locating specific data points or patterns across forms using advanced search capabilities and flexible filtering criteria.
• Visual reporting tools including charts and dashboards to monitor key metrics, identify trends, and flag outliers.
• Integrated site communication via the WebFXP Site Portal, enabling document exchange and communication between research sites and safety teams with real-time collaboration.

Compliance and Audit Readiness

• Complete audit trail capturing every action and data point to support regulatory requirements and Good Clinical Practice (GCP) standards.
• Secure, role-based access control allowing configuration of who can view, edit, or approve each form.
• Customizable event notifications and role- and workflow-based security settings.
• Compliance with 21 CFR Part 11 and support for CDISC/CDASH standards.
• ISO 27001 certification covering the management of all form data.

Support and Training

• Quick user training with minimal requirements — only a browser is needed on the client side.
• Remote training available, as well as in-person onsite training at sponsor facilities.
• Technical support provided with a dedicated 800 number per study.
• Multiple levels of help desk and support options available.

Data Hosting and Infrastructure

• All data hosted on a validated, secure server located in a hardened, redundant hosting facility.
• Full business continuity and disaster recovery functions provided.
• Nightly data backups performed both locally and to a geographically separate location for redundancy.
• 24/7/365 performance and fault monitoring.
• All files remain the client's property and are transferred upon request.

WebFormX is delivered as a browser-based application requiring no client-side installation, and integrates with the Sequence platform to support broader clinical trial operations including document exchange through the WebFXP Site Portal.