Accelerate Your Study: Harnessing AI and Automation for Rapid Study Start-up

In today’s clinical research environment, the pressure to deliver faster, higher-quality results is greater than ever. Clinical leaders, data management professionals and biostatistics teams face persistent challenges with slow database builds, which can delay study start-up, hinder patient recruitment and ultimately impact time-to-market for new therapies. Register for this webinar to learn how AI, automation and standardized workflows can accelerate study start-up while improving efficiency and data quality across teams.

Traditional database setup processes are often manual, fragmented and prone to rework, creating inefficiencies that ripple across data management and statistical programming workflows. These delays not only increase operational risk but also compress timelines for downstream activities such as study data tabulation model (SDTM) conversion and analysis readiness. As the demand for real-time data insights and rapid study deployment grows, the industry needs innovative solutions that streamline workflows, harmonize standards and enable teams to move from protocol to first-patient-in with unprecedented speed and confidence.

In this webinar, attendees will learn how digitized protocols, AI-driven standards comparison and automated electronic case report form (eCRF)/edit check generation — now delivered through IQVIA’s enhanced Medidata EDC offerings — let teams choose the right build path: Fast-Build (~4 weeks) for standards-led studies, Standard (~8 weeks) when moderate tailoring is needed and Custom (~12 weeks) for higher complexity — each governed by IQVIA standards libraries and compliance reporting.

The featured speakers will highlight how biostatistics, automation and cross-therapeutic standards come together in Medidata to boost productivity, consistency and quality across the data lifecycle, with real-world cases showing measurable gains in compliance and operational efficiency. All of this is led by IQVIA’s Data Sciences, Safety and Medical (DSSM) team via Push Button Start-up (PBSU) and EDC Recommender, working hand-in-hand with Medidata EDC to transform database build — from protocol to first-patient-in — with speed and confidence.

Key points will include the strategic value of cross-functional collaboration, the importance of harmonizing standards from protocol design through to analysis and the practical steps organizations can take to avoid working in silos. The DSSM team will also address readiness for client-facing deployment, dependencies on standards metadata and the critical role of presenter expertise in driving successful adoption.

Whether you oversee statistical programming, data management or clinical operations, this session will equip you with actionable insights and proven strategies to accelerate your path to database lock and clinical study report (CSR) delivery.

Why attend?

Join this webinar to gain a competitive edge in clinical trial delivery. Discover how leading organizations are leveraging PBSU and DSSM technologies to overcome bottlenecks, reduce cycle times and ensure submission-ready outputs. Attendees will leave with a clear understanding of how to operationalize governed standards, automate key processes and drive measurable impact across study start-up.

Speakers

Sean Brandyberry, VP, Global Clinical Data Management, IQVIA

Sean Brandyberry oversees IQVIA’s Global Data Management team, including both full-service and FSP work. Prior to joining IQVIA in 2022, Sean held multiple senior leadership roles over diverse data sciences teams at multiple CROs. He brings a disciplined, project management-driven approach to data delivery teams, especially over large, strategic partnerships. Sean has more than 15 years of experience managing Data Management partnerships and more than 25 years of experience in Clinical Data Management and Data Services Project Management.

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Paul Slagle, Senior Director, Statistical Programming, IQVIA

Paul Slagle is the Senior Director of Statistical Programming at IQVIA. He has led multiple teams in the implementation and use of CDISC and other standards over the last 10 years. Paul is also an active member of the CDISC Standards team in leading the development of the ADaM Oncology Examples Document and multiple CDISC Therapeutic Area User Guides. He has also contributed to the SDTM Standards development. Before working and leading the development of standards teams, Paul led the Statistical Programming team at a few CROs and built the Statistical Programming team at a remote site for one CRO. Paul has been working in the pharmaceutical industry for over 20 years and, prior to that, worked in the R&D department for food manufacturing for almost 20 years. Paul is a member of the PharmaSUG Executive Committee and the 2023 Chair for the PharmaSUG Annual Conference in San Francisco.

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Nina Reyes, Director, Clinical Data Management, IQVIA

Nina Reyes is Director of Clinical Data Management at IQVIA, where she leads expert teams dedicated to delivering high-quality, reliable data for clinical trials. With nearly two decades of experience, Nina has driven initiatives that streamline data workflows, enhance governance and implement technology-enabled solutions to accelerate study timelines without compromising compliance or patient safety.

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