• 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
    • JobWatch
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Y-Prime launches Prime Publisher to streamline content review, combine data for reports

Y-Prime launches Prime Publisher to streamline content review, combine data for reports

June 27, 2012
CenterWatch Staff

Y-Prime Technologies, an eClinical products and consulting company of Malvern, Penn., is expanding its suite of eClinical software solutions with Prime Publisher, an easy-to-use concatenation tool that streamlines the content review process and combines multiple data forms into a single, navigable format.

"Prime Publisher offers an integrated, component-based approach to building document content and the flexibility to combine exactly what the  reviewer needs to  see and comment on," explained Dan Glass, vice president of enterprise content management at Y-Prime. "Focusing reviewers and their feedback in large documents containing multiple pieces of information is crucial to reducing re-work and cycle times. Prime Publisher provides much of the functionality of a full-blown system, while being easier-to-use at a fraction of the cost."

The tool simplifies an arduous process such as reviewing large sections of the eCTD.  For example, a Module 2 Quality Overview contains cross-references to information contained in Module 3 Drug Product and Drug Substance Manufacturing and Stability information. A typical Module 3 might contain 200 or more documents for an initial application. Prime Publisher enables an author to select the overview and the relevant Module 3 documents combining them into a single review document.  It reduces time spent flipping between submission components during review and approval processes, especially where business processes and supporting technology allows the reviewer/approver to assign workflow outcomes to all documents simultaneously.

Prime Publisher also helps in preparation for clinical study reports to a global audience.  The tool allows the author to prepare a modular or component-based report to accommodate regional regulatory differences of information provided.

The tool requires minimal training and integrates with industry-leading EDMS systems or fileshares. It offers the flexibility to select virtual documents and leverage an EDMS clipboard (such as inside Documentum and other Documentum-based applications) and also allows multi-select to easily integrate into existing business practices.

All Y-Prime products are backed by 24/7 U.S.-based support, project management and development capabilities.

Upcoming Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

  • 28Jun

    Effective Root Cause Analysis and CAPA Investigations for the Life Sciences

  • 16Oct

    WCG MAGI's Clinical Research Hybrid Conference - 2022 West

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

  • Protocol-360x240.png

    Avoid Deviations by Making Protocol Review a Team Effort

  • SelectionProcess-360x240.png

    Give Us a Voice: Sites Clamor for a Say on Vendor Selection

  • Convince-360x240.png

    Use Data and Details to Convince Site Leadership to Add Staff

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Listing Trial Staff and Others on the Statement of Investigator

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 My Personal Information

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing