About this event
At PHUSE US Connect 2026, Maxis AI showcases how Agentic AI transforms clinical data workflows for statistical programmers, data scientists, and health data professionals.
Visit Booth #10 at PHUSE US Connect 2026 to explore AI-driven validation frameworks, risk-stratified governance, and problem-first autonomous automation that help sponsors, CROs, and biotechs accelerate submissions while improving data integrity and operational efficiency.
What we’re showcasing at PHUSE US Connect 2026
DTect AI — Agentic Anomaly Detection & Risk Intelligence
Combine real-time anomaly detection, accelerated review workflows, and proactive risk management for clinical data quality, purpose-built for statistical programmers and data scientists.
Statistical Computing Environment — Agentic Programming
Support SAS, R, Python, and Julia with Agentic AI for CDISC-compliant dataset generation, interactive data review, and centralized blinded and unblinded study workflows.
Risk-Based Quality Management — Agentic Quality Oversight
Continuously assess risk with autonomous AI agents using ISO, ICH Q9, and FMEA frameworks to identify, prioritize, and recommend mitigation strategies across trial activities.
Verticalized Agentic AI Platform
Apply purpose-built autonomous agents to clinical data review, validation, and submission preparation while keeping knowledgeable human experts in control.
Maxis AI on the agenda — 5 sessions + 1 poster
ML04: Validation Strategies for Agentic AI Platforms in GxP-Regulated Clinical Data Environments
Speaker: Maxis AI
Session Overview: Explore comprehensive validation approaches for Agentic AI platforms in GxP-regulated environments, supporting regulatory compliance while maximizing autonomous capabilities across clinical data workflows.
ML05: Performance-Driven Risk Oversight for AI Agents in Clinical Research
Speaker: Maxis AI
Session Overview: Learn how performance metrics enable proactive quality management, continuous improvement, and accountability for AI agents across regulated clinical research environments.
ML36: Risk-Driven AI Oversight in Clinical Research: A Tiered Framework Using ISO, ICH Q9 and FMEA
Speaker: Maxis AI
Session Overview: Discover a tiered framework integrating international standards with proven risk methodologies for comprehensive, scalable governance of AI systems in clinical research.
AS12: Orchestrating Multi-Agent Workflows for Complex Trial Data Integration
Speaker: Maxis AI
Session Overview: See how multiple autonomous agents can coordinate complex trial data integration to improve quality, reduce manual intervention, and accelerate submission timelines.
AS23: Problem-First Agentic AI — Transforming Statistical Computing with Purposeful Automation
Speaker: Maxis AI
Session Overview: Learn how problem-first autonomous agents address specific statistical computing challenges with purposeful, GxP-compliant automation.
PP06: The SMART+ Framework for AI Systems
Speaker: Laxmiraju Kandikatla, CSV Lead, Maxis AI
Session Overview: The SMART+ Framework introduces a clinical research taxonomy integrating Safe, Monitored, Accountable, Reliable, and Transparent principles for AI systems.
Connect with our team
Meet the experts
Nicole is a strategic leader with over 17 years of experience in the clinical research industry, consistently driving transformative revenue growth across diverse markets. Her expertise lies in building strong partnerships and steering corporate strategies that align with evolving industry needs. An experienced speaker, she presents on technology-driven innovation in clinical research.
Ankur brings over 20 years of experience in clinical strategy, advisory, consulting, and solutioning in SaaS and functional services. His expertise spans clinical data management, statistical programming, biostatistics, data standardization, clinical operations, and digital transformation for thousands of clinical trials.
Rajesh is a PMP- and CSM-certified professional with over 15 years of experience implementing eClinical systems within the life sciences industry. His expertise includes pre-sales engineering, product advocacy, solution implementation, computer system validation, and end-user training.
Laxmiraju Kandikatla brings 13+ years of experience across life sciences, pharmaceutical, and clinical research sectors. As CSV Lead at Maxis AI, he leads validation and compliance frameworks for clinical research systems, with hands-on experience across GAMP 5 Categories 3, 4, and 5. He holds an M.Pharm from NIPER and is an ASQ-Certified Quality Auditor, with expertise in GxP, 21 CFR Part 11, EU Annex 11, and FDA guidance.
Explore our AI Workforce Platform
See how AI agents are transforming study startup, data management, oversight, and regulatory submissions.