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At a Glance:Leveraging common clinical data sources, advancedstatistical methodologies and cutting-edge visualizations,TIBCO Spotfre shits clinical monitoring rom requency-based to proactive, comprehensive risk driven monitoring.

New guidance rom the Food and Drug Administration and the European Medicines

Agency are now supportive o risk-based monitoring as a method to optimize clinical trial

operations and improve the overall drug development model.

Automation and Time SavingsSpotfre oers an innovative approach that leads to a reduction in the number o

physical clinical site inspections while preserving clinical trial data quality and ensuring

patient saety. With Spotfre, the eort spent on complete source-data verifcation can

be signifcantly reduced. The resulting savings (in both time and costs) allows or better

data analysis and better protection o subjects without multiplying costs. Become more

adaptive by aligning appropriate monitoring plans based on risk scores versus traditional

calendar metrics. For example, Spotfre can determine whether onsite or remote

monitoring (i.e., lab portals, eDiaries, EDC) is most appropriate and use centralized

statistical monitoring or data surveillance. Statistical monitoring can also be used to

trigger Clinical Research Associate (CRA) investigation and action planning. This data-

driven monitoring approach provides risk assessments that identiy and evaluate key

risk indicators such as high query counts, screen ailures, early withdrawals, and high

site-time-to-data-entry. These fndings can be shared and collaborated upon with site

monitors irrespective o their location.

Benefts

Fastest to Actionable InsightIncrease agility by providing clinicaldevelopment users throughoutthe organization with unmatchedspeed and exibility to anticipate,answer, and act on answers to riskmonitoring questions.

Visibility into the UnknownUncover trends and patterns thatrepresent risk or opportunity throughintuitive visualizations, analyticdashboards, and applications.Connect to clinical data sourcesand include disparate clinical,operational and saety data in your riskmonitoring program.

Self-Service DiscoveryUse sel-service discovery to drasticallyreduce reliance on IT and eliminatedelay related to data preparation,report building, and spreadsheet

version control.

Universal AdaptabilityEmpower the broadest spectrum oclinical development users across thewidest range o analytic use-cases andprocesses. Whether you need clinicaloperations dashboards delivered ona tablet, exploratory applications onthe desktop, or interactions with apredictive application running in a webbrowser, Spotfre delivers.

TIBCO Spotfre or Risk-Based Monitoring

D A T A S H E E T

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Attributes & CapabilitiesRecommend Actions

Risk scores can be ed into a monitoring

plan tailored to address important

and likely risks identifed during risk

assessment. The plan also includes the

ability to recommend actions based on

business rules.

Visualize Overall RiskMonitoring visit requency can be

compared to risk scores. The comparison

can be viewed in the context o the

severity o risk, number o subjects

randomized, and the number o

monitoring visits per month.

Adjust and Re-Calculate

The number o visits since the last

monitoring visit threshold can easily be

adjusted, and recommended actions can

be automatically re-calculated based

on results.

Hide the Complexity

Program managers, country managers,

study managers, and CRAs can leverage

easy to understand visualizations to

incorporate risk-based monitoring

practices without getting bogged down in

data aggregation and statistical modeling.

D A T A S H E E T

TIBCO Software Inc.(NASDAQ: TIBX) is a provider o inrastructure sotware or companies to use on-premise or as part o cloudcomputing environments. Whether its efcient claims or trade processing, cross-selling products based on real-time customerbehavior, or averting a crisis beore it happens, TIBCO provides companies the two-second advantage the ability to capture theright inormation, at the right time and act on it preemptively or a competitive advantage. More than 4,000 customers worldwiderely on TIBCO to manage inormation, decisions, processes and applications in real time. Learn more at www.tibco.com.

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