Signals Clinical

Signals Clinical™ is a software-as-a-service clinical data science platform from Revvity Signals Software designed to centralize and streamline clinical data review, query management, and medical monitoring within a single AI-assisted workspace. By bringing listings, queries, and medical monitoring together with Spotfire® analytics built in, it enables clinical data managers, medical monitors, safety physicians, clinical operations leads, and sponsors to analyze studies flexibly, accelerate decisions, and maintain compliance-ready oversight throughout every phase of clinical development.

The platform is trusted by a broad range of organizations — from emerging biotechs running first-in-human trials to growing biopharma companies scaling across multiple indications, as well as CROs and large enterprises managing hundreds of trials simultaneously. Signals Clinical is purpose-built to replace disconnected spreadsheets, PDFs, and siloed point tools with a unified, traceable, and inspection-ready environment.

Core Capabilities

• Prebuilt clinical visualizations: Ready-to-use dashboards for labs, vitals, adverse events, and more enable faster anomaly detection without requiring custom configuration.
• AI-assisted queries and issue management: Track, prioritize, and resolve issues with complete visibility across sites and studies. AI translates natural language prompts into auditable database queries, surfacing anomalies and trends without hallucinating or inventing results.
• Explainable, no-hallucination AI: Reviewers remain fully in control through human-in-the-loop validation and transparent outputs that can be traced back to underlying study data.
• Real-time clinical insights: Live data views replace static listings, keeping pace with active trials and enabling rapid, informed decisions.
• Integrated Spotfire® analytics: Combines out-of-the-box standard clinical visualizations with the flexibility to build study-specific or therapeutic-area-specific visualizations in Spotfire, providing both immediate utility and deep customization.
• Traceable, compliance-ready workflows: Every review action is logged to support sponsor oversight and produce inspection-ready traceability, including centralized documentation, version control, and complete audit trails aligned with ICH E6(R3) expectations.
• End-to-end issue and query management: Streamlines the full query lifecycle from detection through resolution across all sites and studies.
• Sponsor–CRO shared access: Enables shared oversight and standardized review processes with sponsor-facing dashboards, even when CROs manage operational execution.
• Agentic AI-powered custom listing generator: Purpose-built AI agents accelerate insights through natural language–driven custom listing generation, enabling real-time access and reproducible analytics at every phase of development.

Who It Is Built For

• Clinical Data Managers: Reduce manual preparation, standardize listings, and launch reviews faster using prebuilt visuals and AI-assisted workflows that surface issues early and streamline query cycles.
• Medical Monitors and Safety Physicians: Gain a clearer view of subject safety across labs, vitals, and adverse events with interactive visualizations that highlight patterns, outliers, and emerging risk.
• Clinical Operations Leads and Sponsors: Monitor study performance and oversight activities across portfolios, CROs, and regions in one place with standardized, traceable review workflows.
• Emerging Biotechs: Start quickly with prebuilt visualizations and templates designed for first-in-human and early-phase trials without requiring large data infrastructure.
• Growing Biopharma: Scale clinical analytics across multiple studies and indications with reusable workflows, portfolio dashboards, and integrated Spotfire® analytics.
• CROs and Enterprises: Enable shared oversight, standardized review processes, and sponsor-facing dashboards across dozens or hundreds of trials.

Security and Compliance

• Secure data: All clinical information is encrypted in transit and at rest to protect sensitive trial data.
• Role-based access: Fine-grained permissions ensure the right stakeholders see only the studies and datasets relevant to their role.
• Audit-ready logs: Automatic tracking of all actions and changes supports regulatory inspections and internal QA reviews.
• ICH E6(R3) support: Traceable, human-in-the-loop review workflows, centralized documentation, and complete audit trails provide sponsors with clear, inspection-ready evidence of independent oversight.
• Enterprise cloud infrastructure: Built on enterprise-grade cloud architecture designed for scalability and reliability.

Integrations and Implementation

• Signals Clinical integrates with virtually any clinical data source, including EDC solutions such as Medidata Rave, Veeva Vault EDC, and many other electronic data capture systems, ensuring seamless data flow across the clinical ecosystem.
• Implementation is significantly faster than traditional clinical systems — most teams load their first study within days to a few weeks, depending on data readiness.
• Reusable mapping templates and out-of-the-box visualizations minimize configuration time, and additional studies, protocols, and datasets can be onboarded rapidly using standardized data structures.

Signals Clinical is delivered as a SaaS platform and supports structured guided trials, proof-of-concept evaluations, and expert consultations to help organizations assess fit against their specific study workflows, data sources, and oversight requirements. The platform is backed by a growing library of resources including white papers, brochures, and webinars focused on AI-assisted clinical development, analytical excellence, and regulatory compliance.