SCDM 2025 Annual Conference

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Transforming Clinical Data Management with Agentic AI at SCDM 2025 

At SCDM 2025’s Festival of Opportunity, where data has all the answers, Maxis AI is showcasing how Clinical Data Management can evolve into Clinical Data Science. Today’s challenges—fragmented systems, increasing data complexity, and rising regulatory scrutiny—often leave teams reactive, spending more time on reconciliation than on insights. Our Agentic AI platform helps professionals shift from data custodianship to proactive data science and oversight, accelerating trial delivery while strengthening compliance.

AI-Driven Clinical Data Science: Transforming Oversight, Compliance, and Insights

  • Unified Data Foundation: By integrating data across EDC, DCT, CTMS, Labs, and Audit Trail logs into a governed single source of truth, clinical teams gain early access to standardized, high-quality datasets. This minimizes reconciliation work and creates more time for scientific exploration and insight generation.

  • Clinical Data Workbench: A central cockpit provides real-time oversight of ingestion, cleaning, and harmonization activities. Instead of navigating multiple systems, data scientists can focus on what matters most: ensuring data reliability and guiding trial decisions.
  • Proactive Data Quality (DTect AI): Quality oversight becomes continuous rather than retrospective. Automated anomaly detection and alerts enable teams to identify issues early, accelerate review cycles, and avoid last-minute surprises that delay submissions.
  • Risk-Based Quality Management: Predictive insights guide teams to anticipate risks before they escalate, enhancing compliance and driving trial efficiency. Risk management evolves from being a checklist exercise to a science-driven decision framework.
  • Audit Trail Reviewer: Audit trail review shifts from manual listings to intelligence-driven oversight, highlighting patterns, unusual changes, and quality scores—helping reviewers focus on areas of true risk.
  • Clinical Data Reviewer: With natural language queries and guided exploration, clinical data scientists can ask questions directly of their data—spotting unexpected signals, verifying coding consistency, and uncovering trends that inform decision-making.

Product Showcase: Agentic AI for Smarter Audit Trail Review and RBQM Integration

📅 Monday, September 29, 2025 | ⏰ 4:15 PM – 4:45 PM EST | 📍 Room: Ballroom I–II
JG2
Joanne Gonzalez
Joanne Gonzalez

Description: Discover how Maxis AI unites Audit Trail Review (ATR) and Risk-Based Quality Management (RBQM) into a single, proactive oversight process. Agentic AI enhances traditional ATR by layering in real-time, intelligent risk-based prioritization—transforming quality oversight from reactive to proactive. In this 30-minute session, you’ll see how Agentic AI reduces risk through phased implementation, enhances quality and operational effectiveness, and leverages automated, cross-system intelligence to turn audit trail review from a compliance task into a strategic advantage.

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    Meet Our Experts:

    Moulik Shah

    Founder & CEO

    Moulik Shah has been at the forefront of leveraging technology to transform pharmaceutical and life sciences clinical trials for over 20 years. A passionate healthcare technology entrepreneur Moulik’s dedication to improving clinical outcomes has fueled his vision of an integrated healthcare ecosystem based on effective use of data and analytics platforms. Moulik has been instrumental in driving innovation and progress in the industry. Under his leadership, Maxis AI has become a leading provider of clinical data and analytics, driving real-world impact in the pharmaceutical and life sciences clinical trials.

    Nicole Powell

    Senior Vice President, Business Development

    Nicole, a strategic leader with over 17 years of experience in the clinical research industry, has consistently driven transformative revenue growth across diverse markets. Her expertise lies in building strong partnerships and steering corporate strategies that align with evolving industry needs. At Maxis AI, Nicole is excited to bring her insights and passion for collaboration to expand the reach of Maxis AI’s Clinical Data Analytics Platform, helping clients streamline trials and achieve their objectives. Nicole recently led business development and marketing at SDC, where she pioneered growth initiatives and contributed to shaping the future of clinical trial technology. An experienced speaker, Nicole has presented at numerous industry conferences on tech-driven innovation in clinical research. She holds a BA from the University of Texas San Antonio and an MBA from Baylor University. Based in Virginia, Nicole enjoys golfing, exploring new destinations, and karaoke in her free time.

    Ankur Goel

    Vice President, Strategic Accounts

    Ankur has over 20 years of experience in clinical strategy, advisory, consulting, and solutioning in SAAS and functional services. His expertise spans across clinical data management, statistical programming, biostatistics, data standardization, clinical ops, and digital transformation for 1000’s of clinical trials.

    Rajesh Hagalwadi

    Director, Clinical Data Solutions

    Rajesh is a PMP- and CSM-certified professional who brings 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 (CSV), and end-user training. He frequently collaborates with account executives to develop strategic account plans, conduct client discovery, and deliver impactful presentations that showcase the technological and business value of Maxis AI.

    Jayasree Ivaturi

    Associate Director, Data Analytics Solutions

    Jayasree has over 15 years of experience in providing analytical solutions using business intelligence and analytical tools. Primarily focuses on understanding key analytical challenges in pharmaceutical environment and working closely with key stakeholders across clinical operations. Expertized in building advanced analytical solutions that establish insights into data, providing signals, patterns, trends, and works across different functions to break down barriers between silos while providing a data-driven integrated & holistic view to end users.

    Marni Romano

    Director, Business Development

    With 17 years of experience in scientific sales, Marni Romano is a dynamic leader in business development. Armed with a background in biology and a master’s in biotechnology, she combines scientific acumen with a problem-solving mindset to help organizations unlock the full potential of their research and development efforts. Marni’s passion lies in building trust-driven partnerships, ensuring clients leverage Maxis AI’s cutting-edge solutions for streamlined clinical trials and data-driven decision-making. Her commitment to integrity, innovation, and collaboration makes her a strategic ally for organizations navigating the complexities of clinical research.

    Beth Resau

    Customer Experience & Events Project Manager

    Beth Resau is a goal-oriented Customer Experience & Events Project Manager with 18 years of expertise in project and event management. As a Certified Meeting Professional (CMP), she excels in streamlining processes, fostering collaboration, and driving operational efficiency. With a strong focus on data-driven decision-making, Beth leverages post-event insights to refine workflows and optimize future strategies. Her commitment to continuous improvement, proactive problem-solving, and meticulous attention to detail make her a valuable asset in delivering high-impact experiences within the clinical data industry.

    Enter Now to Win Big at SCDM 2025 Annual Conference 👇



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