I'm excited to announce that Gupta Programming is expanding its services! Starting in October 2023, we are introducing groundbreaking technology-based clinical tools that will revolutionize the way we approach Quality Control (QC) of Study Data Tabulation Models (SDTMs) and Tables, Listings, and Figures (TLGs). With our new approach, we're committed to making QC processes faster and more budget-friendly for our clients.   

The Journey So Far

My journey to this point has been nothing short of enlightening. As a member of the CDISC-360 committee, I've been involved in designing end-to-end systems based on metadata programming. Additionally, I spent a year auditing an SDTM automation and TLGs template tool by PointCross Life Sciences. This experience has allowed me to rethink the conventional QC process, transforming it from a time-consuming ordeal into a rapid, efficient solution.    

Our innovation empowers statistical programming teams with cutting-edge technology-based clinical tools. These tools guarantee rapid, traceable, and high-quality deliverables, freeing up sponsors and Contract Research Organizations (CROs) to concentrate on source programming tasks. What sets us apart is our unique interface to the metadata mapping system, ensuring CDISC-compliant deliverables and a comprehensive collection of domain-based reports.   

What We Offer based on Your QC SOPs? 

Gupta Programming will deliver QC SDTMs from EDC Data within Weeks: Thanks to advanced mapping techniques and minimal coding, we can convert EDC data into CDISC-compliant SDTMs.  Then, we will export raw to SDTM mapping excel file and SDTM xpts from independent programming.  Finally, we will conduct source and QC comparisons based on your QC SOPs using eDV tool.   

Gupta Programming will deliver QC Tables, Lists and Graphs from Table Shells/SAP, EDC or SDTMs within Weeks: Our technology-based clinical tool can generate high-quality Tables, Lists, and Graphs using predefined domain-based templates or custom designs through a user-friendly drag-and-drop interface. We also offer R script exports for further customization.   

Ready for a Rapid QC Transformation? 

This is your opportunity to streamline your QC process significantly. Get in touch with me, Sunil Gupta, today, and let's discuss competitive fixed-price quotes for your next QC project. Our goal is to help you achieve a rapid submission process with fewer resources and on-time deliverables.    

Conclusion

At Gupta Programming, we are committed to staying at the forefront of clinical data QC innovation. Our technology-based tools are designed to enhance efficiency, reduce costs, and ensure compliance with CDISC standards. Join us on this exciting journey toward a future where QC is not just a necessity but a competitive advantage.  Expect more from your service provider! Contact us today, and let's transform your clinical data QC process together! 

Below are screenshots and references from invited pharma industry conferences showcasing Sunil using the tool.  Please scroll to download white paper and case study PDF files.

• I QC SDTMs using similar process as traditional SAS Progrmaming

• I leverage Smart Transformation Module for Low Coding and Pre and Post Review Mapping

• I point-and-click Table Templates by Domain to QC TLGs without SAS Programming

• Invited PHUSE and PharmaSUG presentations and Webinars
  
• • See how Sunil leverages the tool for Rapid SDTM Generation

                                              

• • Harmonizing Raw Data with CDISC Standards to Streamline SDTMs, Paper (Sunil Gupta, PointCross Webinar)
  • Leveraging the UDM for SDTMs (Sunil Gupta, PhUSE January 2023)
  • EDC Raw Data to SDTM Curation, Mapping and Automation with Xbiom Tool, Paper (Sunil Gupta, PhUSE Connect 2023)

  

• Download Pharma Industry Papers, references and Case Studies
  
• • Eliminating SDTM Double Programming by using a Validation Tool & Dummy Data, Glenn Borgmans, Tine Seeuws
    
  • Compare and Contrast eDV Dashboard & Pinnacle 21 Enterprise (Sunil Gupta, PHUSE US Connect 2024 - Paper, Poster)
    
  • Better CDISC Standards with Metadata Programming, Paper (Sunil Gupta, PharmaSUG 2023)
  • Embracing Automation to Support Drug Development [Contract Pharma Article, 05-03-2023]
  • Four Technological Solutions to Improve Data Quality for AI Initiatives, Tim King
    
  • Experienced the Rapid SDTM Generation Advantage [Xbiom On-time and Under-Budget Advantages]
  • Introduction to SDTM Automation [Xbiom Process Article]
  • Ready to Optimize KPIs with Xbiom [Sponsor/CRO KPI Benefits, MDR User Interface]
  • CDISC 360 Mission [Pharma Industry Goals and SDTM Process Flow]
  • Automating SDTM: A Metadata-Driven Journey, Keith Hibbetts, Eli Lilly and Company [Case Study]
  • CDISC Compliance [eDV]

  • Evolving CDISC to the Next Decades: The CDISC Proof of Concept, Peter Van Reusel, Sam Hume [CDISC 360]

  • Efficiency Comes From Reusability and Repeatability, Hanming Tu, Dave Evans [SDTM Mapping Method]

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