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Signals Medical Review

PerkinElmer Signals Medical Review empowers medical monitors to detect safety signals faster and reduce overall time to submission by combining innovative medical review workflow with advanced analytics.

  • Single, unified data analytics solution – from source to visualization to action
  • Curated analytics experience with configurable alerts on cohorts of interest
  • 360 degree visibility across CDISC domains with built-in patient profiles
  • Medical Review status reporting and tracking
  • Secure, regulatory compliant cloud solution
  • Visualization and analytics powered by industry-leading TIBCO Spotfire

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Overview

The Risk of Missing a Safety Signal

Today’s medical monitors require visibility across data sources, CDISC domains, and access to dynamic analyses, but clinical safety data can be difficult to navigate even with these capabilities. The specific needs of medical monitors performing in-stream safety review remind us that all data challenges are not created equal. Medical monitors can’t afford to hunt for specific subjects of interest, rely on manual tracking of the line listing review process, or invest the time to apply generic analytics capabilities to their day-to-day tasks.

To quickly find and act on data insights, medical monitors require intuitive role-specific workflows for a curated analytics experience.

In-Stream Safety Review: Vital Challenges

With the staggering complexity and volume of clinical trial data, the risk of missing a safety signal for medical monitors and safety review teams is growing exponentially. In a recent informal survey, 37% of respondents cited the risk of missing a safety signal as their single greatest challenge in medical review, followed by slow decision making and the high cost of supporting analytics infrastructure. This risk can place organizations in danger of a delayed or rejected submission or even a market withdrawal, while compromising the safety of trial subjects.

Faster Review, Decreased Risk, Lower Cost

The key to getting submission ready faster is speeding the time to review, collaborate, and make decisions on data. Signals Medical Review allows you to cut through the noise to go straight to the subjects of interest, and analyze data for those subjects with exactly the visual analytics you need.

Secure Cloud

The Signals Medical Review SaaS application meets the demanding requirements for performance, security, and compliance with your clinical data.

  • The PerkinElmer Cloud allows for automatic application updates without complex upgrade projects
  • Allows for lower total cost of ownership (you don’t have to manage IT and servers)

Signals Data Factory

Store all your vast and disparate clinical data and access it when you need it.

  • Expedites the process of setting up new studies
  • Allows for the persistence of data (perfect for cross-study and historical data analysis)
  • Expedites data unification and SDTM standardization

Resources, Events & More

Resource Type File Name File Format
Flyer PerkinElmer Signals Medical Review PDF  1 MB
Poster Signals Medical Review Infographic Link
Webinars Medical Review, Safety Signal Detection, Faster Submission Link