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PerkinElmer Signals Medical Review

Built for medical monitors, developed for subject safety, loved by IT. PerkinElmer Signals Medical Review empowers medical monitors to detect safety signals faster and reduce time to submission by combining innovative medical data review workflow with advanced analytics. All this on a secure cloud infrastructure.

Medical monitors need to:

  • Easily find subjects of interest
  • Quickly gain insights using powerful analytics
  • Efficiently track their review progress
 

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Overview

The Risk of Missing Safety Signals

Medical monitors require instant visibility across data sources and access to dynamic analyses, but subject safety data can be difficult to navigate even with these capabilities. The specific needs of medical monitors performing in-stream medical data review remind us that all data challenges are not created equal.

To quickly find and act on patterns, trends, outliers, and safety signals, medical monitors require intuitive role-specific workflows for a curated clinical analytics experience.

Medical monitors leverage:

  • Curated clinical analytics with fast and flexible subject alerts
  • Visualization and analytics powered by TIBCO Spotfire®
  • Medical Data Review reporting and tracking

IT gains enormous value with:

  • Secure, regulatory compliant AWS cloud solution
  • Ease of maintenance and automatic upgrades with SaaS delivery model
  • Fast clinical data aggregation in Signals Medical Review Data Factory
  • High rate of software adoption by physician monitors
  • Line listing technology with full audit trail

With Signals Medical Review, you never miss safety signals

Increased physician monitor productivity and subject safety

The key to getting submission ready faster is speeding the time to review, collaborate, and make educated 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 clinical analytics you need to never miss safety signals.

Never miss Safety Signals

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White Paper

Clinical Data Aggregation

With larger, longer, and more complex clinical trials, along with more stringent regulatory requirements and oversight, integrating and managing the vast amounts of data arriving at a central integration point from many different trial sources has become a daunting task.

The good news is that innovations in clinical trial technology are underway, promising to improve trial efficiency, accuracy, and the bottom line. Sponsors and CROs are seeking a more effective, comprehensive solution through a more-effective electronic data management strategy that includes an aggregated data repository solution with analytics and real-time access to the fully integrated data.

White Paper Summary

Learn about:

  • The challenges for Sponsors and CROs when integrating a vast array of data sources
  • Typical relational database structures and why they don’t work for clinical analytics
  • Ideal clinical data aggregation solutions for continuous, automatic data consolidation

DOWNLOAD OUR WHITEPAPER TODAY!

PDF 933 KB
Fast, Focused Medical Data Review Use Case by a Medical Monitor

Fast, Focused Medical Data Review

Medical Monitors are overwhelmed by the sheer volume and variety of data they need to sort through to find, investigate and react to safety signals. To reduce the risk of missing a safety issue, and protect trial subjects, monitors need a way to quickly and easily to find what they need without having to hunt through irrelevant data.

Download our whitepaper to learn about the latest innovations and real-world medical data review through adverse event and laboratory values use cases by Dr. Anthony Todd Everhart.

Whitepaper Summary

  • Achieve faster, more effective reviews with a concentrated review workflow
  • Build tailored alerts, identify outliers, patterns and trends, and document and track review
  • Incorporate data visualization workflow dedicated to medical data review to never miss a safety signal

PDF 1 MB
Overcoming Common Challenges of Clinical Data Review

Clinical data review is an intrinsic component of clinical development aimed at assuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a wide variety of clinical trial data and often necessitates the integration of data from multiple sources in order to extract actionable insights. Download our whitepaper to learn the common challenges of clinical data review and the strategies to overcome these challenges.

Whitepaper Summary

  • Tools that cannot be tailored for specific therapies or use cases
  • Existing technologies or processes slow down data review and decision-making
  • Reliance on data reporting from outside groups
  • Lack of a centralized view and collaboration mechanism
  • Inability to perform self-service analytics in near real-time

Whether you’re a start-up or a well-established company, we’ll help you answer three questions that are essential to your success:

  • How do highly productive study teams manage clinical data?
  • How can you remove data bottlenecks and reach better trial outcomes, sooner?
  • How can advanced analytics and services solutions bring urgently needed therapeutics to patients faster?

This paper is the beginning of your transition to a simpler, faster, more agile clinical trial experience.

PDF 649 KB
Risk-Based Medical Data Review Plan

Give your clinical trial team more opportunities to address study integrity in-flight. With a modern the medical data review plan (MDRP), medical monitors themselves struggle to balance productivity with quality as they continue to spend time manually scouring data, leaving little time for clinical analysis of the data they’re reviewing.

In this whitepaper, we outline the elements of a strong MDRP and an approach to operationalize it. Read More.

PDF 736 KB
The Key to a Faster, More Flexible Clinical Trial Process

The Key to a Faster, More Flexible Clinical Trial Process

Clinical development teams are under enormous pressure. Pressure from financial stakeholders, who expect a timely return on their investment; pressure from regulators, who are closely scrutinizing the biopharma industry as it explores new therapeutic platforms; most of all, pressure from patients and their families, who are waiting for much-needed cures and life-enhancing treatments.

As they navigate the lengthy and challenging clinical trial process, study teams need to alchemize these pressures into opportunities for greater collaboration, risk management, and quality.

To master the clinical trial process, you need to master clinical trial data.

Learn how a single, integrated data analytics and visualization platform, supported by an experienced partner, can help you move your investigational product to market more quickly.

Whether you’re a startup or a well-established company, we’ll help you answer three questions that are essential to your success:

  • How are data-related challenges stalling your clinical trials?
  • What do highly productive study teams know about managing clinical data?
  • How can you remove data bottlenecks and reach better trial outcomes, sooner?

This paper is the beginning of your transition to a simpler, faster, more agile clinical trial experience.

PDF 1 MB
Transforming Clinical Development

Transforming Clinical Development

Clinical development continues to advance into new areas of drug development and biopharmaceuticals, medical devices, and diagnostics. As it does, harnessing data becomes more critical – for recognizing unpromising research and avoiding costly failures; and for completing clinical trials safely, efficiently, and quickly.

Data, however, are not easily harnessed. They can be generated by multiple sources, stored at multiple locations and maintained in different formats and systems, all of which make them difficult to search, sort and evaluate. Licensing and other impediments also inhibit the free flow of data.

Some of the most innovative organizations are conducting high quality and profitable research and product development in large part because of their ability to harness data.

Whitepaper Summary

  • Consolidate, visualize and rapidly analysis clinical and non-clinical data
  • Optimize trial operations
  • Gain critical and actionable insights
  • Make informed decisions in clinical trials faster
  • Reduce the risk of missing a safety signal

To learn how innovative organizations do it, click on the link below for a copy of our new white paper “Transforming Clinical Development.".

PDF 2 MB