Unified eClinical Platform

Signant Health's Unified eClinical Platform — marketed under the SmartSignals® brand — is a comprehensive, fully integrated suite of clinical trial technologies designed for sponsors and contract research organisations (CROs) seeking to simplify study design and management without compromising data quality or compliance. Built on a robust EDC foundation, the platform offers modular add-ons including eCOA, eConsent, Randomization, and TeleVisits, all accessible through a single access point and a single sign-on. With more than 3,000 clinical trials supported across its 30+ year history, the platform is proven across studies ranging from simple to highly complex.

The platform's defining characteristic is its single-database architecture, which eliminates the need for back-end integrations between modules. A single configurable designer is used to build EDC studies and all add-on modules, enabling a converged, guided workflow in which users move invisibly between applications — reducing site training requirements and freeing up time for mission-critical study activities and patient care.

Core EDC Capabilities

• Full-featured electronic data capture solution capable of supporting modern trial designs
• Support for eSource data capture, remote source data verification (SDV), and risk-based monitoring
• A growing library of eCRFs with standard edit checks to facilitate easy reuse across studies
• Highly configurable, no-software-coding designer tools that accelerate study builds
• EDC implementation achievable in as little as 4–6 weeks using the single configurable designer

Fully Embedded Add-On Modules

• eCOA — Captures patient-reported outcomes (ePRO), observer-reported outcomes (eObsRO), and clinician-reported outcomes (eClinRO) both at site and at home. Features a consumer-grade, device-agnostic interface supporting BYOD or provisioned devices, completion reminders, reporting for on-time data collection, and biometric authentication to simplify the patient experience.
• eConsent — Streamlines the consent and reconsent process with digital forms, remote review options, and signature capture. Supports fully remote or on-site consenting and enables seamless transition from consenting to screening within the site workflow.
• Randomization — Provides robust and reliable patient randomization fully embedded within the EDC workflow, combined with rapid and transparent emergency unblinding to simplify site staff activities and maintain trial integrity.
• TeleVisit — Delivers secure, compliant video connectivity between site and patient, optimised for low-bandwidth operation, compatible with any web-enabled device, and supporting both ad-hoc and scheduled meetings.

Simplified User Experience

• Single URL and single sign-on provides access to EDC and all add-on modules — eConsent, eCOA, TeleVisits, and Randomization
• Converged, guided workflow enables frictionless movement between all platform components
• Reduced site training requirements and lower site burden, allowing more time for patient-facing activities
• No back-end data integrations required between platform modules due to the single-database architecture

Rapid Setup and Flexible Implementation

• A single, intuitive, no-software-coding designer enables sponsors and CROs to design, configure, and go live with their own studies, including seamless mid-study changes, with minimal training
• Self-service or full-service implementation models allow study teams to choose the approach that best fits their needs and goals
• Highly configurable designer tools and a reusable eCRF library further accelerate study build timelines

Expertise and Support from Signant Health

• Science — Experienced teams covering science and medicine, eCOA science, data management, and in-house biostatistics ensure optimal study design and implementation of best practices
• Logistics — In-house logistics services ensure that all sites and patients globally receive fully configured and tested eCOA devices on time
• Translations and scale management — Signant experts collaborate with eCOA scale authors and translation vendors to ensure the correct scales, correct versions, and reliable translations are used
• Site- and patient-facing helpdesk — A 24/7, multilingual helpdesk provides support to sites and patients whenever it is needed

The Unified eClinical Platform is designed to serve both sponsors and CROs across a broad range of protocol complexities, offering a scalable solution that grows with study needs. Its architecture supports global deployment, multilingual operations, and compliance-ready workflows, making it a comprehensive choice for organisations seeking to consolidate their eClinical technology stack under a single, trusted platform.