Applying AI to Study Simulation: From Design to Analysis

AI-driven simulation is emerging as a powerful way to rethink how clinical studies are designed, tested, and refined. This on-demand session explores how tuned AI models can generate highly realistic synthetic patient cohorts built from aggregated, de‑identified clinical, genomic, and behavioral data. By reflecting real-world variability in disease progression, treatment response, and adherence, these synthetic populations allow teams to test assumptions and explore risk long before a trial begins.

Through a detailed comparison of real Phase 2 drug and Phase 3 device trial data with synthetic datasets generated by Floyd, Crucial Data Solutions’ proprietary AI model using Gemini APIs, the session shows how closely simulated cohorts can mirror actual outcomes. Attendees will see how full study scenarios can be modeled, analyzed, and refined in hours rather than months. When paired with TrialKit, these simulation capabilities extend into execution, enabling protocol validation, endpoint optimization, and advanced analysis within a unified eClinical environment.

Led by Paul Grady and Dr. Leigh Mack, the discussion also addresses ethical, operational, and regulatory considerations, offering a practical view of how AI simulation can support safer, faster, and more inclusive clinical research. Watch on demand to see how study design and analysis can shift upstream—before the first participant is enrolled.

Speakers:

Paul Grady | CEO, Crucial Data Solutions

Paul Grady brings innovation and disruptive change to the clinical trials landscape. Combining 30+ years’ experience in all aspects of clinical research technology, an entrepreneurial spirit, and background as a web developer and database architect, Paul provides valuable insights and a unique perspective on the challenges of clinical trials. He started and successfully exited four other clinical technology companies: Summit Medical Systems; Acumen Healthcare Solutions LLC; Clinsights, Inc.; and MedNet Solutions, Inc.

Leigh J Mack, MD, PhD | Chief Medical Officer, Crucial Data Solutions

Dr. Leigh J. Mack is a seasoned clinical research professional with deep expertise in integrating artificial intelligence (AI) into the clinical trial ecosystem. With a strong foundation in study design, protocol development, and regulatory compliance, Leigh leverages AI and machine learning to enhance patient recruitment, optimize data workflows, and improve trial outcomes. His work includes deploying predictive models for identifying eligible patients from electronic health records, using real-time anomaly detection for safety monitoring, and applying natural language processing to extract insights from unstructured clinical data. Leigh is known for leading cross-functional teams that embed AI-driven tools into clinical operations while ensuring alignment with FDA and EMA regulatory frameworks. Passionate about advancing evidence generation, Leigh bridges innovation and practical implementation to accelerate the delivery of high-quality, patient-centered research.

Kelsi Sigl | Project Manager, Crucial Data Solutions

Kelsi Sigl is a dedicated project manager at Crucial Data Solutions, bringing a thoughtful, psychology-driven approach to her role. With a degree in psychology and extensive experience managing complex projects, Kelsi excels at bridging communication, understanding team dynamics, and guiding projects to successful completion. Her unique perspective allows her to effectively navigate both the technical and human elements of project management, ensuring collaboration and productivity. In her late 20s, Kelsi continues to build her career by combining her passion for psychology with her commitment to excellence in data-driven solutions.