Clinical trials are undergoing a fundamental shift as emerging technologies reshape how studies are designed, executed and evaluated. For biopharma companies, the pressure to accelerate timelines, improve efficiency and reduce risk has made the integration of these technologies increasingly critical.
This webinar will explore how artificial intelligence (AI) and other key technology-enabled approaches are being applied across clinical trials today. From protocol development and feasibility assessment to patient identification, trial execution and data analysis, AI is enabling more informed decision-making earlier in the development process. At the same time, decentralized and hybrid trial models are changing how studies are conducted, expanding patient access and enabling more flexible, real-world data collection.
Alongside these advances, modeling and simulation continue to play a central role in clinical development. As an established and regulatory-accepted approach, modeling and simulation support dose selection, study design and risk reduction, and remain a critical component of data-driven decision making.
Importantly, the application of these technologies must align with evolving regulatory expectations. Considerations such as data quality, transparency, patient representativeness and validation of novel approaches are increasingly central to regulatory review.
This session will provide a practical, integrated view of how AI, decentralized trial technologies and modeling and simulation are being used in clinical trials today, and what biopharma companies should consider when applying these approaches in a regulatory context.
Register for this webinar to learn how AI in clinical trials can improve study design, execution and regulatory readiness.
Speakers
Nate Thompson, Chief Information Officer, Allucent
With over 20 years of leadership experience in life sciences technology, Nate Thompson brings a deep expertise in optimizing digital operations and enabling data-driven decision-making across the drug development lifecycle. Nate has a distinguished track record of leading enterprise-wide transformations, with core strengths in AI integration, real-time data platforms, scalable enterprise architecture and M&A technology alignment. Prior to joining Allucent, he served as Chief Technology & Information Officer at United BioSource (UBC), where he led global technology teams and delivered substantial operational efficiencies. His career spans key technology leadership roles at CROs, including Premier Research and Syneos Health, where he pioneered enterprise architecture strategies and drove innovation in clinical technology platforms.
Nate is passionate about leveraging technology to create meaningful outcomes for both customers and patients.
Message Presenter
Sugato De, Vice President, Product Development Consulting, Allucent
As a former Senior Policy Advisor at the FDA and a seasoned leader within the CRO industry, Sugato De has cultivated expertise in a plethora of regulatory pathways, including dossiers for combination products, expedited pathways, protocol development for medical devices and more. During his 11-year tenure with the Center for Devices and Radiological Health (CDRH) at the US FDA, Sugato developed specialized expertise in drug-device combination products, digital health technologies and critical care medicine.
Message Presenter
Alex MacDonald, PhD, Vice President of Model-informed Drug Development, Allucent
Alex MacDonald, PhD, is an Engineer and Quantitative Pharmacologist by training and received his PhD in physiologically based pharmacokinetics and pharmacodynamics at the University of Sheffield, UK. Alex has over 20 years of cross-pharma experience in modelling, clinical pharmacology and pharmacometrics and joined Allucent from AstraZeneca, where he was most recently Global Head of Respiratory and Immunology Clinical Pharmacology and Pharmacometrics. Alex is well-published across multiple therapeutic areas with different modalities, including respiratory and immunology medicine, oncology and metabolic diseases.
Message PresenterWho Should Attend?
This webinar will appeal to VPs, Directors, Managers and Heads involved in:
- Research and Development (R&D)
- Clinical Project Management/Trial Oversight
- Clinical Operations/Clinical Research
- Medical Affairs/Medical Writing/Pharmacovigilance
- Biostatistics and Data Science
- Regulatory Affairs/Strategy
Plus Chief Medical Officers (CMOs) and CEOs of small and medium-sized biotech/pharmaceutical companies
What You Will Learn
Attendees will gain insights into:
- How AI is being applied across protocol development, patient recruitment and trial operations
- The role of decentralized and hybrid trial approaches in improving execution and patient access
- How modeling and simulation support study design and regulatory decision making
- Key regulatory considerations when applying emerging technologies in clinical trials
Xtalks Partner
Allucent
Allucent is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. The company is purpose-built through the convergence of leading providers to address this unmet need. Today, Allucent is a global provider of comprehensive drug development solutions, including clinical trial operations, regulatory strategy, clinical pharmacology, pharmacovigilance, and biostatistical programming consulting. With more than 30 years of experience in over 70 countries, Allucent’s individualized partnership approach provides experience-driven insights and expertise to assist its clients in successfully navigating the complexities of delivering novel treatments to patients.
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