• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Elligo to evaluate harmonized data model for oncology therapy safety assessments

Elligo to evaluate harmonized data model for oncology therapy safety assessments

October 4, 2017
CenterWatch Staff

Elligo Health Research, a clinical research infrastructure provider, has received an FDA award to evaluate the use of harmonized data models to gather real-world data, which will aid in the safety assessment of new oncology therapies.

While the FDA has already approved various cancer immunotherapies, the agency seeks to better understand their safety in a real-world setting. However, there are multiple ways to collect and represent data, and there is a lack of interoperability—the capability for systems to exchange and aggregate data from various sources. This leads to an inability to combine and analyze data, thus severely limiting its usefulness.

The FDA is leading a project to harmonize various data models so that important data can be more easily shared and interpreted. The resulting data architecture will allow data to be exchanged between existing data models. This approach will be tested by Elligo, using electronic health records as data sources. 

“A data architecture and process that enable meaningful data exchange will allow us to leverage real-world evidence and patient experiences to accelerate learning,” said Rebecca Kush, Ph.D., Elligo’s scientific innovation officer. “Competing data models should not impede access to important information. We commend the FDA for spearheading this project.”

Having this data architecture facilitates data pooling for analysis, making it easier to support evidence-based care and increasing the value of patients participating in research studies.

“While the promise of real-world data for research is great, the ultimate value comes from being able to rapidly share high-quality data from electronic health records,” said Chad Moore, Elligo president. “We’re honored to be part of this project.” 

Upcoming Events

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • tablet

    Digital Intake Platforms Effective as Source of Trial Information, Survey Shows

  • Diversity-360x240.png

    Site Spotlight: EmVenio Research Takes to the Road to Promote Trial Diversity

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing