Cloud-based clinical trial data review and medical monitoring solution powered by Spotfire analytics for pharmaceutical and biotech medical monitors to detect safety signals faster and reduce time to submission.
Signals Medical Review provides clinical development teams and medical monitors with tools to detect safety signals faster and reduce time to submission through medical review workflow and analytics. The solution is powered by TIBCO Spotfire, providing interactive data visualization and analysis capabilities specifically designed for medical monitors and clinical data managers.
The platform provides workflows and analytics to focus data review processes, identify risks early, and enable patient safety. It provides prebuilt standard clinical visualisations combined with the ability to build study-specific or therapeutic-specific visualisations in Spotfire. This flexibility allows clinical teams to adapt the tool to their unique review requirements across all therapeutic areas and all phases of clinical trials.
Signals Medical Review simplifies access to clinical trial data from virtually any source, including major EDC solutions like Medidata Rave and Veeva Vault EDC. The platform's analytics are powered by TIBCO Spotfire and support every use case with full customization capabilities. Solutions can harmonize real-time access to data from multiple sources throughout all phases of clinical development.
Deployment takes 4-6 weeks and is adjustable to organizational needs. Solutions can easily be mixed and matched for specific requirements or scaled to meet an entire clinical portfolio's needs. A top 10 global biopharmaceutical company deployed Signals Medical Review to their clinicians and safety reviewers as part of a safety review tool that is quickly becoming the tool of choice for clinical data review.
In 2024, Revvity Signals Software announced the evolution of this product into Signals Clinical, an expanded solution to accelerate critical clinical trial insights and data-driven decisions across medical monitoring, clinical operations, and safety surveillance.
Pharmaceutical Edition
Signals Medical Review is purpose-built for pharmaceutical and biotechnology clinical development teams. The solution is designed specifically for GxP-regulated clinical trial environments with SOC 2 attestation for enhanced security and compliance. The platform supports medical monitoring workflows across all therapeutic areas (oncology, rare diseases, CNS, cardiovascular, etc.) and all phases of clinical development (Phase I through Phase IV).
Core Capabilities
FDA & GxP Compliance
International Standards
Security Certifications
Data Integrity & Validation
Signals Medical Review is a cloud-based SaaS solution deployed on Amazon Web Services (AWS) infrastructure. The platform is powered by TIBCO Spotfire, providing interactive data visualisation and analysis capabilities.
The solution supports integration with multiple EDC systems including Medidata Rave, Veeva Vault EDC, and other clinical trial data sources. Data harmonization capabilities enable real-time access to data from multiple sources throughout all phases of clinical development. The platform is designed with a scalable architecture that can be deployed in 4-6 weeks and adjusted to organizational needs.
SOC 2 attestation provides enhanced security controls for biopharmaceutical research and clinical trial data. Revvity supplies validation readiness documentation for regulated GxP environments. The system is not delivered pre-validated: the customer executes the validation against its own procedures.
Signals Medical Review uses a subscription-based SaaS pricing model. Pricing is not publicly disclosed on the vendor website and requires contacting Revvity Signals sales team for quotes. The solution can be purchased as a standalone product or as part of the broader Signals Clinical suite announced in 2024.
Deployment cost and timeline are variable based on organizational scope: 4-6 weeks for standard implementations with adjustable configurations for specific study or portfolio requirements. Enterprise pricing likely varies based on number of users, clinical trial volume, and level of customization required.
Signals Medical Review deployment takes 4-6 weeks from initiation to production use. The implementation is adjustable to organizational needs and can be scaled from single-study deployments to enterprise-wide portfolio solutions.
The platform can be mixed and matched with other Revvity Signals Clinical components for specific requirements or deployed as a comprehensive solution. Professional services support is available for implementation, configuration, and training. Validation documentation is provided as part of the SaaS platform. The customer executes the validation; Revvity does not supply the system pre-validated.
PharmaSpotter assessment from published vendor and third-party sources. No user reviews are on file for this product.
Strengths
Top 10 global biopharmaceutical customer reports that Signals Medical Review is quickly becoming the tool of choice for clinical data review among their clinicians and safety reviewers. The platform combines prebuilt standard clinical visualisations with the flexibility to build study-specific or therapeutic-specific visualisations. Deployment takes 4-6 weeks. Multi-source data integration capabilities harmonise access to clinical trial data from Medidata Rave, Veeva Vault EDC, and other EDC systems.
Limitations & Open Questions
Limited public customer evidence with only one referenced case study (top 10 biopharma, name not disclosed). Pricing transparency is lacking with no publicly available pricing information. The platform is powered by third-party TIBCO Spotfire analytics engine, which may introduce licensing dependencies. Product is transitioning from standalone Signals Medical Review to integrated Signals Clinical suite (2024), which may create uncertainty about long-term product roadmap and branding.
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