Phuse US Connect 2026

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.

Presenter: Anaya Rehman

Compliance with EMA Policy 0070 remains challenging due to gaps in governance, inconsistent document quality, and weak anonymization and CCI management, often leading to delays and increased regulatory risk. In this session, we will introduce a practical compliance checklist that translates regulatory expectations into clear, actionable steps, and demonstrate how it reduces errors, improves consistency, and supports faster, more confident submissions.

Presenters: Honz Slipka, Certara and Popescu Radu, EMA

Balancing transparency with the protection of sensitive information remains the most pressing challenges in clinical trial disclosure. This session will explore points of conflict and convergence among sponsors, regulators, and transparency specialists in the evolving data anonymization landscape.

Presenters: Michele Andrush and Anaya Rehman

In this session, we will examine why ClinicalTrials.gov PRS submissions remain highly manual and resource intensive. We will present an AI-enabled approach that generates structured PRS field content directly from study protocols, share early results showing reduced manual effort with maintained completeness, and discuss how this approach points toward more efficient and streamlined trial registration workflows.

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.

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.