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Study Oversight & RBQM

Insights you can act on

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Actionable insights in real time from aggregated data sources

Drive quality evidence generation

Monitor clinical data quality throughout the trial using targeted real-time data visualizations.

Leverage our visualization tools

Leverage our visualizations and develop your own, using our user-friendly business intelligence interface.

Include any data source

Use our Clinical Data Hub to ingest, standardize, and aggregate data in real time from multiple sources.

Implement risk-based monitoring strategies

Select, define, and review risk indicators to drive targeted study monitoring.

Enable 360-degree patient data review

Integrated medical and data management review on aggregated data.

Gain a complete picture using all your data

Medical Review

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Perform a comprehensive 360-degree review of patient safety using fully integrated data from all sources, in one place. Streamline activity using integrated medical review checklists.

Risk-based quality monitoring

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Select, define, and track quality indicators to drive targeted study monitoring and central monitoring activity based on TransCelerate, MCC, or in-house risk indices.

Custom analytics & visualizations

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Review integrated data using standard dashboards and visualizations, or develop your own with our easy-to-use analytics interface.
Decorative profile picture

Perform a comprehensive 360-degree review of patient safety using fully integrated data from all sources, in one place. Streamline activity using integrated medical review checklists.

9-1

Select, define, and track quality indicators to drive targeted study monitoring and central monitoring activity based on TransCelerate, MCC, or in-house risk indices.

icon-choose
Review integrated data using standard dashboards and visualizations, or develop your own with our easy-to-use analytics interface.

Why choose Signant SmartSignals? 

Make better decisions, faster, using Signant SmartSignals Study Oversight. With the growing volume and variety of data collected in today’s clinical trials, Study Oversight enables real-time study data review and monitoring from all your data sources, in one place. Used together with our Clinical Data Hub, SmartSignals Study Oversight empowers sponsors and CROs to gain the complete picture of study progress and data quality, ensuring efficient medical and data management review, risk-based quality monitoring, and early signal detection for timely, actionable insights.

Rapid deployment

Deploy in days or weeks using our out-of-the-box business intelligence solution in combination with our Clinical Data Hub.

Timely data insights

Enable actionable insights from validated, integrated data, in real time.

Cross-study insights

Easily combine with historic data for deeper insights on site performance and selection.

Comprehensive support

Get ready to go rapidly with our customer enablement and support teams.

Risk-based quality monitoring

Design and implement risk-based monitoring plans using our library of risk indices, or develop your own.

Simplified medical monitoring

Eliminate the need to consult multiple, disparate reports and data sources – see all patient data integrated, in a single place for a holistic, 360-degree patient review.

FAQs

What data sources does the Clinical Data Hub ingest?

We ingest data in any format, structured or unstructured, including (but not limited to) ODM, line listings, XML, JSON, SAS export, SAS data files, etc.

What data formats do you export?

Clinical Data Hub transforms the aggregated source data into industry-standard models such as SDTM, E2B R2, ADaM etc., or to user-configured custom data model formats.

How do I use Study Oversight?

Study Oversight is an out-of-the-box SaaS solution used in combination with our Clinical Data Hub to provide access to real-time aggregated data sources.

Want to learn more?

Make better decisions, faster, using Signant SmartSignals Study Oversight – contact Signant today.

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