October 7 - Breakouts - IQVIA TechIQ 2026

3:00 - 4:30 PM

Designed for senior clinical leaders with biotech, emerging biopharma and mid-size pharma companies, this 90-minute breakout explores how data, technology and AI can improve trial design, predictability and speed. Smaller and growing organizations often face the challenge of advancing innovative therapies without the resources to build and integrate complex technology ecosystems on their own. Through an interactive peer roundtable and conversations with sponsor leaders, attendees will hear real-world lessons on using technology to make more informed clinical decisions, strengthen operational oversight, improve data quality, and increase confidence in trial execution.

Join industry peers to explore practical strategies for navigating increasingly complex studies with greater visibility, stronger risk management, and the confidence to make faster, more informed clinical decisions.

Agenda:

3:00 - 3:10 PM | Welcome
Welcome and introduction to the key theme for the session: how tech can help clinical decision makers make more informed decisions. Highlight the unique challenges facing smaller and growing organizations, where lean teams must balance speed, risk and execution without the infrastructure typically available to larger pharmaceutical companies.
3:10 - 3:30 PM | From Science to Delivery: Designing Trials Built for Success
As trial complexity grows across oncology, rare disease, obesity, CNS and precision medicine, sponsors need more than strong science to achieve successful outcomes. Explore how early alignment on endpoint strategy, fit-for-purpose COA selection, AI-enabled workflows and technology integration can strengthen study design and execution. Learn practical approaches for diverse trial designs, managing operational complexity, and making more informed decisions that improve trial predictability from protocol design through delivery.
3:30 - 3:50 PM | Predicting Trial Success: Turning Data Into Actionable Oversight
Visibility into data collected by technology alone is no longer enough. Clinical leaders need the ability to identify risks early, protect data quality, and confidently steer programs toward successful outcomes. Explore how real-time access to incoming clinical and operational data enables teams to identify missing, inconsistent or inaccurate information before it impacts study execution. Learn how automated data transfers, triggered quality alerts, compliance monitoring, and analytics dashboards help protect endpoint data, support proactive intervention, and improve decision-making. Attendees will gain practical insights into leveraging connected technologies to strengthen data quality, enhance compliance and increase confidence in both trial delivery and financial predictability.
3:50 - 4:20 PM | Before You Go Global: Lessons We Learned the Hard Way
Launching a global clinical program brings opportunities but also challenges that many sponsors underestimate. In this candid moderated discussion, CEOs and Clinical Operations leaders share what they wish they had known before expanding globally, from building the right operational infrastructure and scaling teams to navigating country selection, oversight and execution risks. Gain practical insights, avoid common pitfalls, and learn how experienced leaders are creating a stronger foundation for predictable and successful clinical development.
4:20 - 4:30 PM | Closing Remarks
As clinical development becomes more complex, success increasingly depends on an organization's ability to make timely, informed decisions across study design, execution and oversight. Peter will summarize key lessons from the session and reflect on how data, technology and AI are helping sponsors reduce uncertainty and make more confident clinical development decisions.

3:00 - 5:00 PM

The successful implementation of Good Practice (GxP)‑compliant AI in Quality Management and Regulatory Operations depends on strong control, trusted data and disciplined processes to convert innovation activities into safer more effective products and improved patient outcomes.

This two-hour session is designed for senior quality and regulatory leaders seeking to move beyond experimentation toward scalable, governed, operational GxP AI. As AI becomes embedded across QMS, RIM, post-market surveillance and regulatory interactions, the priority shifts from access to technology to ensuring it operates within auditable, inspection-ready frameworks built on harmonized data, standardized processes and validation aligned to global regulations.

Through a client presentation and executive panel, the session will explore how leading organizations are building these foundations to reduce fragmentation, strengthen regulatory confidence and identify risks earlier across the product lifecycle, while maintaining a relentless focus on patient safety, product quality and global compliance.

Agenda:

3:00 - 3:10 PM | Welcome & Introduction
Introduction to the key themes supporting how leading organizations deploy AI‑enabled QMS and RIM solutions: trusted data, standardized processes and robust governance are needed to strengthen regulatory confidence, identify risks earlier and improve patient safety, product quality and global compliance.
3:10 - 3:35 PM | Customer Fireside - Establishing the Digital Foundations for GxP Performance at Scale
Learn how strategic investments in data, process harmonization and governance created the control, consistency and confidence needed to improve compliance, productivity and business performance.
3:35 - 4:25 PM | Panel Discussion - Control, Risk and the Path to Trustworthy Adoption of GxP AI
This panel explores how QARA leaders are preparing for and/ or governing AI within GxP environments to deliver trusted, regulator‑ready outcomes. Discussion will focus on the role of data governance, AI governance frameworks and validation aligned to context of use, while addressing critical risks such as model drift, bias and explainability. Panelists will share practical approaches to preparing for AI in QMS and RIM solutions, managing AI risk, maintaining global compliance and ensuring that intelligent systems remain controlled, auditable and aligned with evolving regulatory expectations.
4:25 - 4:50 PM | IQVIA Showcase Demonstration - Agentic Native GxP AI for Quality and Regulatory Excellence
Experience SmartSolve’s GxP compliant AI in action, demonstrating governed automation across quality and regulatory processes to improve decisions, compliance, productivity and outcomes.
4:50 - 5:00 PM | Closing Remarks
Wrap up the session and state how commercializing safe and effective healthcare products is achieved through governed AI, trusted data and operational excellence.

Omni Boston at the Seaport