• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Certara introduces Preclinical Safety Store to capture and validate file-based study data

Certara introduces Preclinical Safety Store to capture and validate file-based study data

April 29, 2014
CenterWatch Staff

Certara, a global technology-enabled drug development and drug safety consultancy, has launched its Preclinical Safety Store (PCSS). A companion product to D360, Certara’s integrated solution for the query, analysis and visualization of drug discovery and development data, PCSS enables the capture and validation of file-based preclinical study data in a CDISC-SEND architected database, meeting FDA recommendations for standardization of data formats for study data in regulatory submissions.

Pharmaceutical customers who pair PCSS with D360 will be able to access preclinical study data from CROs in minutes, in a consistent format, for study monitoring and cross-study analysis. PCSS also offers a terminology mapping tool that provides a consistent view of study data from multiple sources.

PCSS was developed in collaboration with D360 customers to address specific challenges that they were facing, such as CROs supplying their data in different file forms and using different names for the same test. PCSS uploads study data files into a SEND-based data system so that the information can be readily queried and analyzed by D360. PCSS also standardizes the naming convention used to match either CDISC-SEND controlled terminology or a customer’s own.

“Capturing study data using PCSS allows real-time study monitoring; it takes just minutes to upload and query the data and eliminates hours of complex file manipulation. That, in turn, permits rapid decision making about ongoing studies,” said Jonathan Feldmann, Certara chief technology officer. “Furthermore, by facilitating trend analysis of past studies, PCSS helps improve study design and drug development research.”

Upcoming Events

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 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

  • SurveywBlueBackground-360x240.png

    Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds

  • TrendsInsights2023-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Two

  • TimeMoneyEffort-360x240.png

    Time is Money and So Is Effort, Budgeting Experts Say

  • TrendsInsights2023A-360x240.png

    WCG Clinical Research Trends and Insights for 2023, Part Three

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