Join Certara at PHUSE US Connect 2026 to learn how Pinnacle 21 helps sponsors and CROs achieve submission-ready clinical data with greater confidence, consistency, and efficiency. Meet with our experts to see how automated validation, configurable rules, and streamlined review workflows support evolving CDISC and regulatory requirements, reduce manual effort, and enable faster, higher-quality submissions.
Meet with Pinnacle 21 submission experts at PHUSE US Connect 2026
Date: March 23 – 25, 2026 | Location: Austin, TX, USA
Walk away with clear guidance on CDISC compliance, validation efficiency, and submission readiness - tailored to your studies
In a 30-minute meeting, you can:
Identify data conformance risks before submission
Understand how to reduce manual validation effort
Get clarity on evolving CDISC & regulatory expectations
See how Pinnacle 21 supports faster, cleaner submissions
Explore Certara presentations on CDISC, RWD, and submission readiness
Common Issues in BIMO Clinical Site Dataset Packages
Monday, March 23 | 3:00-3:30 PM
Presenter: Michael Beers
Preparing Bioresearch Monitoring (BIMO) Clinical Site (CLINSITE) datasets for submission can be challenging, and issues are frequently identified during regulatory review. This presentation reviews the most common problems seen in CLINSITE datasets and supporting documentation, explains why they occur, and provides practical guidance on how to address them to ensure compliance with FDA specifications and guidance.
Submitting RWD: Where We Are and Where We Are Going
Tuesday, March 24 | 2:00-2:30 PM
Presenters: Jeffrey Abolafia, Ingeborg Holt, Sarah Ferko
As the use of real-world data (RWD) in regulatory submissions continues to grow, both sponsors and regulators face new challenges. This session examines the current regulatory landscape and required standards for submitting RWD, evaluates emerging initiatives such as expanded CDISC standards, JSON submissions, and HL7 FHIR, and provides short- and long-term recommendations for submitting both randomized controlled trial and non-interventional study data.
SDTMIG v4.0: Are You Ready for It?
Wednesday, March 25 | 3:00-3:30 PM
Presenter: Kristin Kelly
The release of CDISC SDTMIG v4.0 represents a major shift in SDTM standards. This presentation explores key updates – including Multiple Subject Instances (MSI), Non-Standard Variables (NSVs), metadata restructuring aligned with SDTM v3.0, new and updated domains, and reorganized guidance sections, and provides practical recommendations to help sponsors prepare for and successfully navigate this significant transition.
Reserve your on-site meeting at PHUSE
Meet directly with Pinnacle 21 experts to discuss your submission challenges and get actionable recommendations. On-site meeting slots are limited and advance booking is recommended. Fill out the form to book your 1:1!
