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See Signals Clinical in action
See Signals Clinical in action

Clinical Analytics

Turn Fragmented Clinical Data Into Faster, More Confident Decisions

Bring together purpose-built clinical review, flexible visual analytics, and clinical expertise to improve data review, medical monitoring, study oversight, and safety analysis.

Solution Hero Foreground Image

Built for data management, medical and safety teams, clinical operations, sponsors, CROs, and clinical analytics leaders.

How Greywolf Strengthened Clinical Trial Oversight

Daily
Clinical trial data updates
Replacing monthly and ad hoc reporting
Shared
Cross-functional trial visibility
One up-to-date view of trial data across teams
Zero
Added headcount
Enterprise-level oversight without expanding the team

Clinical Teams Need More Than Fixed Dashboards

Clinical development brings together data from EDC, labs, safety systems, vendors, and operational sources. But every team—and every study—needs to answer different questions. 

Data Management Identify data-quality issues, accelerate review, and reduce dependence on programming queues.
Medical & Safety Move quickly from population-level patterns to the patient-level context needed to investigate what matters.
Clinical Operations & Sponsors Gain clearer visibility into study execution, partners, risk indicators, and follow-up.
Clinical Analytics Teams Explore the study-, therapeutic-area-, and portfolio-specific questions that predefined dashboards can’t anticipate.

Connected clinical analytics combines repeatable workflows with the flexibility to answer what’s unique to every study.

Clinical Review Shouldn’t Take Months — It Should Take Moments

 

Today, clinical teams lose valuable time to fragmented data, manual processes and disconnected systems that can’t keep up with modern trials. Address these real bottlenecks to move from manual effort to faster, more confident decisions.

Three key benefits of streamlined clinical review: eliminate biostat delays with analysis-ready outputs, unify fragmented review processes across PDFs, emails and spreadsheets, and centralize decision oversight with clear, real-time visibility.

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One Clinical Analytics Foundation. Multiple Critical Workflows.

Clinical Data Management & Review

Accelerate listing review, identify data-quality issues, generate custom listings, manage issues and queries, and reduce dependence on programming.

Medical Monitoring

Move from population-level safety and efficacy signals to individual patient context across AEs, labs, vitals, medications, dosing, and subject timelines.

Solution:

Clinical Operations & Oversight

Monitor sites, enrollment, data cleaning, queries, milestones, operational trends, and risk indicators to support centralized and risk-based oversight.

Solution:

Pharmacovigilance & Safety Analytics

Explore safety data across studies and populations to identify patterns, investigate potential signals, and support evidence-based safety decisions.

Flexible Clinical Analytics

Answer study-, therapeutic-area-, and portfolio-specific questions as requirements evolve, beyond predefined dashboards and standard workflows.

Solution:

Sponsor & CRO Collaboration:

Improve shared visibility into review activity, responsibilities, findings, decisions, and follow-up across internal teams and external partners.

Solution:

Portfolio Analytics

Compare patterns, risks, study performance, and emerging questions across trials, programs, indications, or therapeutic areas.

AI-Assisted Review

Use governed AI-assisted workflows to accelerate routine review while preserving reviewer judgment, inspectability, and traceability.

Connected Review Workflows

Bring data, investigation, decisions, queries, and documented follow-up into a shared clinical context.

What Our Customers Are Saying

Quote from AMBRX

“Safety signals buried within hundreds of lines of inert data are easy to miss.”
“The platform is very intuitive and easy-to-use… [and] the entire cross-functional team is able to use this tool on a daily basis

AMBRX

Quote from Natalie Hyland — Head of Clinical Operations, Greywolf Therapeutics

"With the daily updates, we can visualize our clinical trial data live. Now I can’t imagine working without it."

Natalie Hyland — Head of Clinical Operations, Greywolf Therapeutics

How Signals Clinical supports early safety signal detection

Surface risk faster

 by visualizing adverse events by severity, frequency, and body system across the full study population

Drill down instantly

 from population signals to individual subject timelines with synchronized events, labs, and dosing

Reduce manual effort

 by replacing static listings and ad hoc analyses with interactive, study-bound visuals

Support defensible decisions

 with captured context, review actions, and traceable rationale aligned to regulatory expectations

Whitepaper

Real-Time Clinical Data Insights Delivered by Automation and AI

See how automation and AI can unify clinical data, accelerate review, strengthen continuous oversight, and support traceable, compliance-ready decisions across modern clinical trials.

Whitepaper

SHIONOGI’s Spotfire Data Science Story

Ready to accelerate your specialty chemicals R&D?

The presentation, delivered by Shinichi Fukunaga san from the Data Science Department of Shionogi, is titled “SHIONOGI’s Company-wide Data Utilization Initiatives and How Spotfire is Used.”

Which approach fits your clinical data review?

See how Signals Clinical compares to manual review and disconnected tools.

Signals Clinical
Other vendors
Signals Clinical Unified clinical data workspace designed for oversight and review
Other vendors Spreadsheets and PDFs disconnected from source systems
Signals Clinical AI-assisted workflows with built-in traceability capturing decisions and rationale
Other vendors Siloed point tools requiring manual reconciliation
Signals Clinical Pre-built visualizations plus Spotfire flexibility
Other vendors Custom reporting that requires time-consuming rework
Signals Clinical Shared context across teams for aligned, defensible decisions
Other vendors Fragmented reviews with limited visibility and traceability

Partner testimonial

Insights from Revvity Signals roundtable

At Revvity Signals Clinical roundtable, clinical, data, and medical leaders explored how AI can be responsibly applied to real-world clinical workflows. The discussion surfaced a clear consensus: progress depends on practical automation, human-in-the-loop governance, and trust-built systems that accelerate insight without compromising oversight or patient safety.

Agentic AI-Powered Clinical Data Review: From Manual Listings to Guided Oversight

How Signals Clinical™ + Spotfire® help clinical teams generate listings faster, improve traceability, and make more confident review decisions with human-in-the-loop AI. 

 

Clinical data review often begins with labor-intensive, manual listing generation and fragmented workflows that slow decision-making and weaken traceability. This presentation introduces an agentic, AI-powered approach to modernizing clinical data review shifting teams from static, manually produced listings to guided, reviewer-controlled oversight. 

 

With Signals Clinical™ integrated with Spotfire®, clinical teams can generate line listings using natural-language prompts through the AI Listings Generator, then seamlessly transition into the structured Line Listing Review experience. Reviewers retain control throughout the workflow by marking rows, adding notes, raising issues, and posting queries. Review activity is captured to support audit-ready, end-to-end traceability. 

 

By combining AI-generated outputs with interactive visual analytics and collaborative review mechanisms, this approach improves traceability and accelerates progress from identified findings to documented issues and queries. Additional capabilities such as exportable outputs, exportable issue tracking (including comments), on-demand checks before issue creation, and bulk line listing review help teams improve efficiency while sustaining high-quality, human-led review decisions at scale.

Signals Clinical Connect Oct 2026
Remote video URL
Signals Clinical Connect Oct 2026

Governed AI as an Enabling Capability

Keywords:

  • AI-assisted review
  • Human-in-the-loop
  • Traceable decisions
  • Reviewer oversight
  • Reproducible workflows
  • Clinical data review

Signals Clinical™

Purpose-built clinical review: data access, listings, issues and queries, AI-assisted workflows, review actions, collaboration, and traceability.

Explore Signals Clinical

Spotfire®

Flexible clinical analytics: prebuilt visualizations plus deep study-, therapeutic-area-, operational-, and portfolio-specific exploration when requirements evolve.

Explore Spotfire

Clinical Analytics Expertise & Services

Connect data, configure analytics, operationalize workflows, and adapt the environment as studies and customer requirements change.

Talk to an Expert

Signals Clinical

Streamlines clinical data workflows and reduces the time spent preparing data for analytics to enable the rapid delivery of clinical insights.

Spotfire

Revvity, the exclusive provider of Spotfire® for scientific and clinical R&D applications, empowers your team to drive data-driven decisions.

Resources

Signals Clinical FAQs

Signals Clinical is an AI-augmented clinical data review platform that unifies listings, query management, medical monitoring, and oversight into one solution - powered by Spotfire® for real-time visual insights.

Unlike tools that rely on static listings or manual exports, Signals Clinical provides live, visual insights, AI-assisted issue detection, centralized review, and a complete audit trail. It reduces reliance on programming queues and accelerates decisions across studies.

Yes. Signals Clinical enables traceable, human-in-the-loop review workflows, centralized documentation, and clear audit trails, supporting sponsor oversight expectations under ICH E6(R3), ALCOA+, and internal QA review processes.

No. Signals Clinical provides analysis-ready data, prebuilt visualizations, and guided workflows so clinical teams can review data without waiting in programming queues. Programmers can still contribute, but reviewers don’t rely on them to start analysis.

Signals Clinical uses AI-augmented (not generative) models to surface anomalies, detect trends, and prioritize review areas, while keeping the reviewer fully in control. It provides explainable insights and avoids hallucinations.

Absolutely. Signals Clinical supports shared review, role-based access, issue management, and cross-functional dashboards, enabling data managers, medical monitors, CRAs, and QA teams to work from one system rather than fragmented tools.

Yes. Signals Clinical is the only clinical review platform with built-in Spotfire® analytics, enabling instant visualizations and powerful exploratory analysis without external dashboards.

The platform supports labs, vitals, AEs, concomitant meds, queries, protocol deviations, custom listings, SDTM/ADaM structures, and any additional structured datasets that support clinical review workflows.

Most customers begin reviewing live study data in days to weeks, not months. Prebuilt listing templates, out-of-the-box dashboards, and guided workflows accelerate onboarding.

Yes. Signals Clinical supports shared oversight, standardized workflows, and transparent collaboration. CROs can use the platform directly or provide sponsor access for full visibility.

Every action (comments, queries, issue transitions, data changes, and reviews) is automatically logged, creating a complete audit trail that supports inspections and internal QA.

You can start with a free trial, explore a live demo, or speak with an expert to map Signals Clinical to your workflow needs.

Clinical Analytics supports data management, medical and safety, clinical operations, pharmacovigilance, sponsor, and CRO teams across biotech and biopharma organizations.

The solution supports clinical data review, medical monitoring, study oversight, safety analytics, portfolio analysis, and emerging questions that require flexible clinical exploration.

AI-assisted workflows should keep reviewers in control, make outputs inspectable, preserve traceability, and support reproducible review rather than replace clinical judgment.

Services can help connect data, configure analytics, operationalize workflows, and adapt the environment as studies, therapeutic areas, and business requirements evolve.

Ready to Strengthen Your Clinical Analytics Strategy?

Talk to a Clinical Analytics Expert

Discuss your data, workflows, teams, and emerging analytics needs across review, medical, operations, and safety. 

Talk to an Expert

Explore the Clinical Analytics Solution

See how purpose-built workflows, flexible Spotfire® analytics, and clinical expertise work together across clinical development.

Explore the Solution

See Signals Clinical in Action

Go deeper on the purpose-built product for clinical data review, AI-assisted workflows, collaboration, and traceability. 

Watch the Demo