Review Design
A view specification with linked filters, marking and subject drill-down.
At Review
Can a reviewer follow the question from cohort to subject?
Clinical / Spotfire Intelligence
Investigate the Study Without Losing the Subject Context.
Spotfire consulting and implementation for clinical data review: connect cohort filters, patient profiles and safety views in the environment your team controls. Agree data preparation, analysis configuration and operating controls for the review workflow.
For Medical monitoring, clinical data review and Spotfire platform teams
01 / Your environment02 / Your protocol03 / A named reviewer
The Engagement / Spotfire Intelligence
What Your Team Receives.
Choose a defined review workflow, such as cohort-to-subject safety review. Agree the selected deliverables and review criteria in the scope.
Data Engineering
SDTM and ADaM preparation, documented calculations and refresh checks.
At Review
Are data relationships and displayed values traceable?
Configured Analyses
Versioned analyses and access controls within the agreed Spotfire environment.
At Review
Do selections and permissions work for each intended role?
Release and Handover
Acceptance tests, change documentation, training and an operating guide.
At Review
Can the study and platform teams own the accepted workflow?
Clinical / Software Workflow
Follow a Safety Signal Through the Workspace
Filter a study population, mark a laboratory observation and inspect the linked subject and event records. Every subject and measurement here is sample. The interface is an INNOVIZZ illustration informed by Spotfire review patterns.
Play the guided walkthrough or choose a phase. Pause to read, and use Previous or Next at your own pace. Tables can be scrolled on smaller screens.
Watch the Recorded Workflow
Original INNOVIZZ interface simulation with on-screen explanation.
Technical Accuracy and Demonstration Limits
Table relations and filtering propagation must be configured for the linked views shown here. All 24 subjects, their laboratory values and events are sample. Planned visits without observations remain blank. Independent ALT and bilirubin peaks can occur on different dates; threshold lines alone are not a diagnosis or a Hy’s Law assessment. The saved note is a browser demonstration, not a production audit record.
Sources checked 24 October 2026: SAS developer documentation and community, Spotfire documentation and community, PHUSE 2026 papers. The registry-derived examples elsewhere on this site are explicitly separated from these simulations.
Workflow Transcript and Boundaries
- Inspect the 24-subject sample population.
- Filter Site 02 to six subjects.
- Mark subject S02-003 and reconcile the linked listing.
- Inspect the 12 observed measurements across 20 planned visits.
- Review event timing alongside the laboratory trajectory.
- Retain a review note with population and source context.
Product features, permissions and licensing are confirmed for your deployment.
Try the review logic / Original interactive illustration
Change the Cohort.
Follow a Subject.
This small demonstration shows the interaction model behind a clinical Spotfire build. It uses 24 sample subjects and runs locally in your browser. It is not an embedded Spotfire application or a clinical decision tool.
Linked liver-safety exploration
Population → Subject
Independent maxima, shown against illustrative 3× ALT and 2× bilirubin ULN reference lines. A flagged point needs medical context, not an automatic conclusion.
Longitudinal profile
Twenty planned timepoints: Screening, Visits 1 to 18 and Follow-up. Sample values for demonstrating linked review, not observed trial data.
Inspect the synthetic subject data
| Subject | Site | Arm | Peak ALT / ULN | Peak bilirubin / ULN | Disposition |
|---|
Why bring INNOVIZZ into the work?
Data Preparation, Linked Review and Operating Support.
Bring INNOVIZZ in when the work spans clinical data preparation, linked analyses and platform operation. Agree one review workflow and its acceptance tests, then receive the configured analyses, documented logic and handover.
Sponsor-owned Infrastructure
On-premise or self-hosted cloud architecture, identity integration, role-based permissions, recovery planning and performance testing. Confirm authorization in the server and data layers; a dashboard filter is not a confidentiality boundary.
Deliverable: architecture, access tests and operating runbook.CDISC-aligned Engineering
SDTM ingestion, ADaM derivation support, metadata-driven transformations, information links where appropriate, and scoped Pinnacle 21 checks. Reconcile source counts and preserve the meaning of each denominator.
Deliverable: documented transformations, reconciliation and lineage.Clinical Review That Connects
Patient profiles, enrollment, adverse events, lab shifts, exposure, endpoint progression and PK/PD where relevant. Build the linked views and definitions around the protocol and the reviewer, with separate DMC reporting access where required.
Deliverable: review specifications, versioned analyses and acceptance evidence.Refresh and Oversight
Plan EDC and vendor transfers, refresh orchestration, source-status checks and operational alerts. Agree the freshness target with RAVE, Veeva, Oracle or other source-system owners; refresh speed depends on those interfaces.
Deliverable: refresh monitoring, exception handling and assigned ownership.Optional Model-assisted Prioritization
Where justified, evaluate enrollment slowdown, site outliers or anomaly prioritization. Define validation, false-positive handling and a reviewer’s disposition before introducing a model into the workflow.
Deliverable: bounded use case, evaluation record and human review path.A scoped engagement / In your environment
Stabilize. Refine. Hand Over.
Infrastructure Stabilization
Assess deployment and permissions, establish the data pipeline and deliver an agreed baseline review view.
Protocol-specific Views
Refine protocol-specific views, patient profiles, oversight and DMC reporting. Add model-assisted prioritization only where justified.
Operate and Enable
Transfer source and analysis ownership, train reviewers and agree support. Multi-study expansion follows acceptance of the first scope.
Agree the selected analyses, data sources and review schedule before starting. Scope existing-environment improvements separately from new platform or dashboard development.
Discuss your Spotfire environmentContinue within Clinical
Explore the Connected Capabilities.
These are proposed services and original workflow illustrations, not customer results or a vendor endorsement. Spotfire is a trademark of Cloud Software Group. INNOVIZZ is not affiliated with or endorsed by Cloud Software Group.
Demonstration References
Product Documentation and Source References
Public references used to design this original illustration. Product versions, licenses and configuration must be confirmed for a client implementation. The example does not establish production performance or validation.
- Spotfire clinical safety demohttps://www.spotfire.com/learn-connect/demos/clinical-study-safety-demo
- Spotfire getting startedhttps://www.spotfire.com/learn-connect/get-started
- Spotfire documentationhttps://www.spotfire.com/learn-connect/docs
- PHUSE EU 2025 AS02https://phuse.s3.eu-central-1.amazonaws.com/Archive/2025/Connect/EU/Hamburg/PRE_AS02.pdf
- PHUSE US 2018 DV17 / LexJansenhttps://www.lexjansen.com/phuse-us/2018/dv/DV17.pdf
- INNOVIZZ existing Spotfire servicehttps://innovizz.com/clinical-intelligence/spotfire/
Clinical / Your Next Decision
Scope Your First Spotfire Review Workflow.
Confirm the analyses, data relationships and platform responsibilities together. Define what your reviewers must be able to trace before accepting the build.
Built for Your Team to Operate.
Receive the agreed source or configuration, specifications, test records and operating handover. The statement of work identifies client-owned deliverables, existing INNOVIZZ methods, third-party licenses and support terms.