Monitor Your Data

Know Your Risks
Improve Your Oversight

Gain better visibility into clinical
study milestones and metrics across
your entire program, for improved
risk-based assessment.



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It's Your Data

Clinical Study Monitor Gives You Access So You Can Take Control

Risk-Based Monitoring

View progress toward key data accrual, query response, deviation, and adverse event metrics for early detection of factors that have the potential to impact submission milestones.

In-Depth Safety Analysis

View summarized adverse event data across studies, and drill down to both study and subject level for in-depth analysis.

Responsive One-Click Analytics

Quickly slice and dice your data utilizing filters customizable to meet your specific dosing scenarios.

Scalable Data Platform

A fully scalable data environment houses both internally and externally sourced clinical and operational data and can accommodate future growth.

Cloud-Based Components

Solution components can be cloud-hosted for cost efficiency, or can reside in-house.

Complete Data Support

Our experts support your data environment, working with you and your CRO's to ensure the integrity of your source data.


Explore Clinical Study Monitor Features



Program Safety Monitor Dashboard

The Program Safety Monitor Dashboard includes metrics that help management-level resources better assess safety data across the entire study platform.

Customizable filters enable users to slice data by program, study, and dosing scenarios applicable to your organization: Users can:

  • View key population metrics
  • Monitor subject disposition
  • Assess adverse event metrics and alerts, with drill in to greater detail.
  • Apply additional filters for advanced safety analysis.

Study Monitor Dashboard

The Study Monitor Dashboard includes metrics that help clinicians better assess the progress toward study milestones and monitor metrics that provide insight into possible risks, with drill in by site and subject. Clinicians can:

  • View study-specific milestones and monitor enrollment projections
  • Track subject disposition and deviations
  • Measure data accrual metrics and monitor progress toward query response
  • Assess adverse events by seriousness, relationship, and toxicity grade, and sort by system organ class and preferred term

Integrated Data Respository

A SQL-Server based integration environment stores both internally and externally sourced operational and clinical study data in one centralized repository.

  • Flexible and scalable data load components allow the load a wide variety of file sources and formats from multiple internal sources or third-party vendors.
  • Smart validation processing normalizes and stores data in a format consumable for solution reporting components.
  • Cross study data is then available in one centralized location, and supports dashboard reporting with rich data visuals, eliminating the manual effort to compile, merge and report on data from separate vendors.


Success Story

Clinical Study Monitor Improves Cross-Platform Operational Oversight

The client, a mid-size pharmaceutical company, was looking to create a centralized data environment that standardized and aggregated data sources from principal investigators to improve cross-study data access and support growing reporting needs. Data was received from multiple vendors in multiple formats, and not stored within a single centralized location. Resources were struggling with manually requesting data from CROs, and constantly refreshing static Excel reports. The client needed a cost efficient, scalable report platform that could merge and normalize the data AND provide rich report visuals with drill down to tabular data.

Clinical Study Monitor delivered both the integrated data environment with an automated load of data from multiple CROs, and web-based access to visually rich dashboard reporting, with drill-in capability to supporting detail. The client now has the ability to view and analyze safety, disposition, and data accrual metrics across studies with no manual intervention, and has increased its ability to make business decisions that positively impact company operations with increased efficiency.



Learn More About Clinical Study Monitor

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