EDC

Signant Health's EDC is a comprehensive electronic data capture solution with a 30-year track record, designed to meet the demands of modern clinical trials. Built for sponsors, CROs, and clinical research sites alike, it combines ease of use, flexibility, and exceptional service within a unified eClinical platform. Whether running simple studies or highly complex oncology trials, Signant's EDC delivers the agility and depth required to support efficient, high-quality data collection and management.

The platform supports both full-service and self-service models, enabling teams of all sizes to configure and launch studies quickly. With mobile-enabled eSource collection, remote source data verification (SDV), and seamless integration with optional add-on modules, Signant's EDC is built to reduce operational burden while maintaining data integrity across every stage of a trial.

Four Core Reasons Customers Choose Signant's EDC

• Ease of Use: Sites benefit from intuitive interfaces that guide users to their next required actions. Sponsors appreciate CRA workflow directions and convenient integration capabilities. Self-service users can design studies without coding, supported by an extensive out-of-the-box library of eCRFs, edit checks, and custom functions.
• Flexibility: The no-coding EDC accommodates both simple and highly complex study designs, including oncology studies with undefined numbers of cycles and varying cycle lengths across study arms.
• Exceptional Service: Both full-service and self-service customers receive attentive support from dedicated project managers and support teams. No customer is considered too small, and no question is treated as unimportant.
• Efficiency: Study set-up is completed in four to six weeks, and protocol amendments can be rolled out with no system downtime.

Data Collection and Management Capabilities

• Rapid implementation to accelerate study start-up
• Direct data capture option for eSource collection
• Local and central lab data integration
• Automated medical coding
• Secure, clean data management throughout the trial lifecycle

Monitoring and Quality Control

• Remote monitoring and remote SDV, allowing sites to upload source data evidence for CRA review and sign-off without requiring travel
• Facilitates risk-based and targeted monitoring approaches
• Risk-based SDV definitions can be adjusted at the click of a button as individual site risk profiles evolve
• Experienced and attentive project team support throughout the study

Study Set-Up and Configuration

• Flexible configuration suitable for both simple and complex study designs
• No-coding study design interface accessible to self-service users
• Seamless mid-study protocol amendments with site-level versioning and no downtime
• Comprehensive library of eCRFs, edit checks, and custom functions available to both full-service and self-service customers

eSource Capabilities

• Fully mobile-enabled eSource data collection with a responsive design optimised for tablets and smartphones
• Supports on-site consultations by investigators and home visits by nurses
• Clear data genealogy tracking to distinguish eSource data from transcribed data

Optional Add-On Modules

• eCOA: Capture patient-reported outcomes directly using an intuitive, device-agnostic interface, supporting both BYOD and provisioned devices for home and site-based use.
• eConsent: Streamline the consent process with digital forms, remote review options, and signature capture for both remote and on-site settings.
• TeleVisit: Enable secure, compliant video visits to simplify patient follow-up in decentralised and hybrid trial models.
• Randomization: Implement patient randomisation and emergency unblinding directly within the EDC workflow.

Signant's EDC sits at the core of the company's fully unified eClinical platform, with all add-on modules integrating seamlessly when needed. The platform is available as both a full-service and self-service offering, supporting a wide range of sponsor and CRO operational models. Teams looking to discuss their data capture strategy or explore the platform can request a solution tour directly with Signant Health.