Webinar
Accelerating CSR Timelines: Applying Real-Time Data, Governed Standards and Expert Oversight
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September 23, 2025

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11:00am - 12:00pm

(GMT-04:00)

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Pharmaceutical sponsors are under increasing pressure to reduce the time from database lock to clinical study report (CSR) while maintaining data quality and regulatory compliance. This webinar will demonstrate how large and mid-sized pharma organizations can apply technologies and standards to streamline data flow, eliminate rework and accelerate submission timelines.

Attendees will see how real-time data analysis, governed by Clinical Data Interchange Standards Consortium (CDISC) standards and automation, can transform traditional workflows into scalable, high-quality processes that support faster delivery of CSRs whilst ensuring high quality.

The session will feature the practical application of DSSM technologies and the critical role of data standards engineers in aligning protocols with Clinical Data Acquisition Standards Harmonization (CDASH), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) from the outset. These experts provide strategic and tactical oversight across the data lifecycle, helping biostatistics, data management and clinical operations teams harmonize standards, adapt to evolving trial designs and ensure submission-ready outputs. Real-world use case will illustrate how to reduce cycle times from weeks to days while improving compliance and operational efficiency.

Attendees will also gain actionable insights into how centralized standards repositories, consumption governance and tech-enabled automation can deliver long-term value across portfolios.

Whether leading statistical programming, managing data operations or overseeing trial delivery, this session will equip attendees with an understanding of the tools and strategies being used to operationalize governed standards and DSSM technologies for measurable impact.

Register for this webinar now to learn how to accelerate the path to CSR with confidence and consistency.

 

Attendees will gain insights into:

Data Standards Technologies in Action
  • Discover how data standards technologies are being practically applied to streamline clinical data workflows and reduce time from data lock to CSR
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    Unlock the Power of Real-Time Data Analysis
  • Learn how real-time data cleaning and analysis, enabled by governed standards and automation, can accelerate decision-making and improve submission readiness
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    Leverage Standards-Based Approaches for Consistency and Compliance
  • Understand how aligning with CDISC standards (CDASH, SDTM, ADaM) from the outset reduces rework, improves data quality and ensures regulatory compliance across studies
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    Maximize Efficiency with Expert Oversight
  • Explore how data standards engineers provide strategic and tactical guidance to harmonize data, manage evolving trial designs and support faster, higher-quality submissions
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    Speakers:

    Emma Bickford, Senior Director Biostatistics, IQVIA

    Karen Zieker, VP Biostatistics, IQVIA

    Dries Becker, Associate Director Statistical Programming, IQVIA

    Paul Slagle, Senior Director Statistical Programming, IQVIA

     

    For more information and to register, click here.

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