On Tuesday, April 14, get an exclusive look at where Pinnacle 21 Enterprise is headed as we shift from point-in-time checks to continuous confidence across the clinical data lifecycle. Explore current and upcoming enhancements to improve governance, validation efficiency, and reduce rework. The afternoon includes a presentation from AstraZeneca, a regulatory-oriented update tying changing expectations to standards and submission workflows, and rapid-fire roundtables to share tactics for automation, analytics, and readiness.
On Wednesday, April 15, get hands-on training to deepen your Pinnacle 21 mastery and drive earlier data quality and readiness. Hear from your peers with customer presentations on real-world outcomes. The afternoon is interactive, with teams working through common clinical data and validation problems, then a “Shark Tank” style review of USDM and protocol-focused solutions. A closing panel discusses continuous submission readiness using metrics and issue tracking to avoid late-stage fire drills.
Tuesday, April 14, 2026
Agenda
7:15 – 8:15
Breakfast & Badge Pick Up
8:15 – 8:30
Welcome to Certainty
Our Certainty theme in 2026 is “Right from the start”. Together, we’ll delve into how the how AI enabled modeling and simulation supported by digital data flows is improving decision making at every stage of R&D and bringing the best new medicines to patients.
8:30 – 9:15
Sheila Rocchio, Matt Rizk
The Innovation Circle: Driving Outcomes in R&D
Ideas, actions, and collaborations driving productivity, insight generation and a faster, more flexible and patient centric approach to medicine discovery and development. This session will share insights from leaders in drug discovery and development responsible for driving digital transformation and integration to driver, faster and more agile decision making.
Panel Moderator: Sheila Rocchio
Panelists:
Matt Rizk, PhD, Associate Vice President, Translational Sciences & Outsourcing
Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics, Merck
9:15 – 10:00
Chris Bouton
Right from the Start: AI Enabled Science and Scientists: Introducing Certara Nexus for faster, model-informed decision making that regulators Trust
This session will showcase how AI is changing drug discovery and development focusing on insights and speed that democratize modeling and simulation insights earlier to speed the most promising new medicines to patients. An early look at new capabilities coming soon to the Certara portfolio will be demonstrated in this session.
Speaker: Chris Bouton, PhD, Certara CTO
10:00 – 10:30
Morning Break - Demo Bar
10:30 – 11:00
Erin Erginer
Roadmap & Vision: Advancing Certainty Across the Clinical Data Lifecycle
As organizations mature in their use of Pinnacle 21 Enterprise, expectations shift from point-in-time validation to continuous confidence across the clinical data lifecycle. This session outlines the product vision guiding the next evolution of Pinnacle 21 Enterprise, and how it supports Certara’s commitment to Certainty Right from the Start.
Erin Erginer, Senior Director of Product, will share how customer insights, emerging regulatory expectations, and real-world workflow challenges are shaping the Pinnacle 21 Enterprise roadmap. The discussion will focus on advancing automation, improving cross-functional visibility, and enabling earlier, more connected decision-making, from study design through submission and beyond.
Topics will include:
- How Pinnacle 21 Enterprise is evolving to support earlier validation and proactive data quality
- Expanding capabilities for metadata-driven workflows, standards governance, and traceability
- Enhancements that improve collaboration across data management, programming, and biostatistics
- Scaling from study-level execution to portfolio-level insight and readiness
- How customer feedback from P21 Live directly influences product direction
This session is designed for experienced Pinnacle 21 users who want to understand not just what’s coming next, but why and how future capabilities align with the practical realities of modern clinical development.
11:00 – 11:45
Matt Meyers, Trevor Mankus, Amy Garrett, Fred Hurley
What’s New in Pinnacle 21 Enterprise: Features, Enhancements, and What’s Next
Pinnacle 21 Enterprise continues to evolve in response to how teams are using the platform in real-world clinical data workflows. In this session, members of the Pinnacle 21 Enterprise product management team will walk through key features and enhancements released since the last P21 Live, highlighting how these updates support earlier validation, stronger governance, and more efficient collaboration across functions.
Designed for experienced users, this session goes beyond a feature list to explore how recent capabilities can be applied in practice, helping teams streamline validation workflows, improve visibility across studies and portfolios, and reduce downstream rework. Product leaders will also offer a sneak peek at functionality currently in development, including eCRF Creator, and discuss how these capabilities fit into a broader vision of building certainty from the very start of the clinical data lifecycle.
Topics will include:
- Notable enhancements introduced over the past year and how they address common user challenges
- Practical use cases for applying new functionality within existing P21 Enterprise workflows
- How recent updates support standards management, data management, programming, and biostatistics teams
- An early look at features in progress, including eCRF Creator, and their role in upstream data quality
This session is ideal for Pinnacle 21 users who want to stay current on platform capabilities, explore advanced functionality, and understand how new features can be leveraged to strengthen confidence across the clinical data pipeline.
Presenters: Matt Meyers, Trevor Mankus, Amy Garrett, Fred Hurley
11:45 – 1:00
P21 Customer presentations
Certara is proud to welcome to the stage the following experts from among our Pinnacle 21 customers.
Mitchell Brahin
Director, R&D IT – Development & Late TA, IT Product Management Clinical Standards
AstraZeneca
Prathima Surabhi
Director, Standards Developer
AstraZeneca
Molly Broad, MSc
Director, Global Clinical Solutions Technologies
AstraZeneca
Have a topic you’d like to present? Register and check the boxes for I’m interested in speaking and P21 Live.
1:00 – 2:00
Lunch & Demos
2:00 – 2:30
Michael Beers, Kristin Kelly
Regulatory Update: What’s Changing—and What It Means for Your P21 Workflows
Regulatory expectations for clinical data quality, standards, and submissions continue to evolve, often with direct implications for how teams design studies, manage standards, and validate data throughout the lifecycle. In this session, regulatory and standards experts from Certara and Pinnacle 21 will provide an update on recent and emerging regulatory guidance, with a focus on what experienced Pinnacle 21 users need to know now.
Rather than a high-level overview, this discussion will connect regulatory developments to practical workflow considerations, including how teams can interpret guidance consistently, anticipate downstream impact, and build regulatory confidence earlier in the process. The presenters will also highlight where Pinnacle 21 Enterprise helps operationalize regulatory expectations, supporting clearer decision-making, stronger traceability, and more predictable submission outcomes.
Topics will include:
- Recent updates and trends in global regulatory expectations related to data standards and validation
- Practical implications for SDTM, ADaM, and submission workflows
- Common areas of regulatory focus that create late-stage risk
- How early alignment and continuous validation support regulatory confidence
- What teams should be watching next and how to prepare
This session is designed for clinical programmers, biostatisticians, standards leaders, and data management professionals who want to stay ahead of regulatory change and ensure their workflows continue to support certainty right from the start.
Presenters: Michael Beers, Kristin Kelly
2:30 – 3:30
Julie Ann Hood, Trevor Mankus, Amy Garrett, Michael Beers
Speed Conversations: Peer Insights from Across the P21 Community
This fast-paced, speed-dating style roundtable session is designed to spark meaningful peer-to-peer conversations across the Pinnacle 21 community. In a series of short, facilitated discussions, participants will rotate between tables focused on key challenges and opportunities in today’s clinical data and validation workflows.
Each roundtable centers on a single question related to automation, standards, analytics, and submission readiness, encouraging participants to share what’s working, what’s not, and what they would do differently if they were starting again. The format emphasizes conversation over presentation, creating space for honest dialogue, cross-functional perspectives, and practical takeaways.
Insights captured during the session will be synthesized and shared during the event wrap-up, highlighting common themes and emerging priorities from across the P21 user community.
This session is ideal for attendees who want to learn from peers, exchange ideas quickly, and explore how others are building certainty right from the start.
Discussion group moderators: Julie Ann Hood, Trevor Mankus, Amy Garrett, Michael Beers
3:30 – 4:00
Afternoon Break
4:00 – 5:00
David Fajgenbaum, MD
Keynote Presentation
5:00 – 5:15
Close of Day
Wednesday, April 15, 2026
7:30 – 8:30
Breakfast & Badge Pick Up
8:30 – 9:00
Sean McGee
From Protocol to Submission: A Certara Workflow
Like a decathalon, a clinical study is a series of challenges. Selecting the right endpoints. Drafting a protocol. Setting up data collection. All this needs to happen before the first patient visit. From there, it’s wave after wave of data validation and analysis, reporting and table-creation, and the million-and-one checkpoints of submission.
How much time, cost, and pain might be saved by relying on a suite of interconnected solutions, each purpose-built for its task? Find out in this fast-paced demonstration of Certara capability from protocol to submission. In 30 minutes, you’ll see how our increasingly AI-driven technology supports your organization right from start, when a study is little more than a justified hope. Sean McGee will present solutions for endpoint selection, optimal trial design, data standardization, analysis, reporting, and more. Live 5-plus years of the trial life in a half-hour, all with Certara by your side.
Presenter: Sean McGee, MS, Director of Product, Certara
9:00 – 10:30
Julie Ann Hood, Trevor Mankus, Amy Garrett
Hands-On Training: Practical Skills for Building Certainty with Pinnacle 21 Enterprise
Regulatory expectations for clinical data quality, standards, and submissions continue to evolve, often with direct implications for how teams design studies, manage standards, and validate data throughout the lifecycle. In this session, regulatory and standards experts from Certara and Pinnacle 21 will provide an update on recent and emerging regulatory guidance, with a focus on what experienced Pinnacle 21 users need to know now.
Rather than a high-level overview, this discussion will connect regulatory developments to practical workflow considerations, including how teams can interpret guidance consistently, anticipate downstream impact, and build regulatory confidence earlier in the process. The presenters will also highlight where Pinnacle 21 Enterprise helps operationalize regulatory expectations, supporting clearer decision-making, stronger traceability, and more predictable submission outcomes.
Topics will include:
- Recent updates and trends in global regulatory expectations related to data standards and validation
- Practical implications for SDTM, ADaM, and submission workflows
- Common areas of regulatory focus that create late-stage risk
- How early alignment and continuous validation support regulatory confidence
- What teams should be watching next and how to prepare
This session is designed for clinical programmers, biostatisticians, standards leaders, and data management professionals who want to stay ahead of regulatory change and ensure their workflows continue to support certainty right from the start.
Presenters: Julie Ann Hood, Trevor Mankus, Amy Garrett
10:30 – 11:00
Morning break
11:00 – 12:30
Fred Bermont, Michelle Brooks, Erica Gonzales, Ave Beatty
Ensuring Clinical Data Quality at Collection: Advancing Data Acquisition Standards and Governance Using ryze
High-quality, compliant clinical data underpins efficient trial execution, regulatory readiness, and trustworthy analytics. We’ve implemented ryze as the central platform to author, manage, and govern clinical data acquisition standards across our portfolio, aligning study design, EDC collection, CDISC, and global regulatory expectations. In this presentation, you will learn:
- Why a governed data-acquisition foundation is critical for CDISC and global regulatory alignment.
- How ryze centralizes authoring, management, and documentation of clinical data standards, including search and reuse of historical study designs.
- How cross-functional committee review is streamlined through clear visualization of structure, controlled terminology, and business rules.
- How approved standards are rapidly deployed to studies, with controlled waivers and comparison reporting to identify and document deviations.
- How this transparency supports downstream teams (dashboards, data warehouse, SDTM mapping) and reduces rework, risk, and cost.
- What’s next: migrating business rules into ryze metadata and standardizing external vendor dataset metadata to improve integration and cross-study comparability.
Presented by the Moderna Data Governance Team
- Fred Bermont, Sr. Director, Clinical Data Standards and Integration
- Michelle Brooks, Director, Clinical Data Standards
- Erica Gonzales, Associate Director, Clinical Data Standards
- Ave Beatty, Associate Director, Clinical Data Standards
12:30 – 1:30
Lunch
1:30 – 2:30
Bryan Farrow, Julie Ann Hood, Trevor Mankus, Amy Garrett, Erin Erginer
Data Challenges: Solving Real-World Problems Together
This hands-on, discussion-driven session invites participants to tackle realistic clinical data and validation challenges drawn from everyday Pinnacle 21 Enterprise workflows. Working in small, cross-functional groups, attendees will examine common data issues, such as inconsistent SDTM variables, validation conflicts, or metadata mismatches, and collaborate to identify root causes, potential fixes, and opportunities for earlier prevention.
The focus of this activity is not on coding or tools, but on how teams think through data problems. Participants will discuss what went wrong, where the issue originated in the data lifecycle, and how improved processes, governance, or automation could have created certainty earlier.
After each challenge, groups will reconvene to share their solution paths, compare approaches, and reflect on common themes. Facilitators will then connect these insights to how Pinnacle 21 Enterprise can support earlier validation, better traceability, and more consistent workflows.
This session is ideal for clinical programmers, biostatisticians, data management professionals, and standards leaders who want to learn from peers, sharpen problem-solving skills, and explore how collaboration and automation can turn data issues into opportunities for improvement.
Moderator: Bryan Farrow, Roving helpers: Julie Ann Hood, Trevor Mankus, Amy Garrett, Erin Erginer
2:30 – 3:00
Erin Erginer
USDM & Protocol Solutions: A Shark Tank–Style Deep Dive
This hands-on, discussion-driven session invites participants to tackle realistic clinical data and validation challenges drawn from everyday Pinnacle 21 Enterprise workflows. Working in small, cross-functional groups, attendees will examine common data issues, such as inconsistent SDTM variables, validation conflicts, or metadata mismatches, and collaborate to identify root causes, potential fixes, and opportunities for earlier prevention.
The focus of this activity is not on coding or tools, but on how teams think through data problems. Participants will discuss what went wrong, where the issue originated in the data lifecycle, and how improved processes, governance, or automation could have created certainty earlier.
After each challenge, groups will reconvene to share their solution paths, compare approaches, and reflect on common themes. Facilitators will then connect these insights to how Pinnacle 21 Enterprise can support earlier validation, better traceability, and more consistent workflows.
This session is ideal for clinical programmers, biostatisticians, data management professionals, and standards leaders who want to learn from peers, sharpen problem-solving skills, and explore how collaboration and automation can turn data issues into opportunities for improvement.
3:00 – 3:30
Christine Galanti
Panel discussion: Submission Readiness Without the Panic
For many experienced P21 users, the goal has shifted from passing validation at submission time to achieving continuous submission readiness throughout the study lifecycle. This panel explores how teams are redefining submission preparedness, and how early decisions in standards, metadata, and validation workflows can dramatically reduce last-minute stress.
Panelists will share how they use Pinnacle 21 Enterprise beyond final checks, leveraging advanced capabilities such as study- and portfolio-level metrics, trend analysis, and centralized issue tracking to assess readiness long before the finish line. The discussion will also highlight the evolving role of standards management and data management teams in creating the foundation for confident, predictable submissions. Attendees will gain insight into:
- Identifying early indicators of submission risk
- Using validation metrics to support proactive decision-making
- Aligning programming, biostatistics, and data management around shared readiness goals
- Moving from reactive fire drills to continuous confidence
This panel is designed for teams ready to transform submission readiness from a stressful milestone into a steady, manageable process, built on certainty from the start.
Moderator: Christine Galanti, Senior Customer Success Manager
Panelists: Radhika Kale, MS, Alnylam Pharmaceuticals
3:30 -3:45
Close of day
Reserve your spot
Reserve your spot for the Certainty US 2026 customer event for exclusive access to the Certara community of experts, industry leaders, and peers as we collectively explore the latest innovations and opportunities to bring greater certainty to drug discovery and development.
