Day 1 - 16th October & IRT Professionals DayWednesday, 16 October 2024 - EST/EDT (Eastern Daylight, GMT-4)

• Where will IRT sit in your organization
• in-house, SaaS, or traditional vendor
• Platform of single service approach
• Outsourcing models include CROs
• UAT outsourcing or in-house
• Running RFI's

• What in IRT systems is redundant from a site perspective?
• What processes are helping or hindering them?
• What is IRT’s role in making things easier for sites?
• Support sites want and need from sponsors and vendors.
• What are the wants and needs with regards to data exchange?
  
  

Expert Insight and Actionable Strategies for a Robust RTSM Test Approach

Join industry expert Susan Vong for an insightful presentation on test strategies you can apply to your next User Acceptance Testing (UAT) process. Explore real-life scenarios of potential pitfalls and discover practical solutions to protect the three critical areas of RTSM: randomization, unblinding, and dosing. Learn about "The Poxy Way," a robust UAT methodology developed by Poxy Clinical, and see how it was successfully applied to accelerate timelines while ensuring quality across key cross-functional areas like Clinical Operations, Clinical Supplies, and Biostatistics.

Key Takeaways from This Session:

• Master the foundational principles of The Poxy Way to drive a successful UAT framework
• Discover how to effectively verify your randomization strategy and the steps to engage your Biostats.
• Gain actionable strategies ready for immediate integration into your testing framework to achieve quality and speed.

Join this session as Susan shares her expertise behind Poxy's test methodologies, drawing from her experience in successfully delivering UAT services for hundreds of UATs across 50+ sponsors. Don’t miss this opportunity to gain valuable insights—join this session and be a part of the discussion as we drive the industry toward a new standard of quality.

• Why IRT could benefit a FIH/early phase trial
• Designing an IRT System for FIH/early phase trials
• Case study evaluation: Successes and challenges of the IRT system in an ongoing FIH trial

• What do sponsors mean when they say they want a full flexible system?
• What are the systems they truly want to integrate?
  • i.e. web services, DCTs etc.
• When it comes to flexibility and integration what are people working towards – better site experience? Quicker protocol amendments? Etc?
• What role does the ability to be agile as a company play in this?
• What new systems are on the horizon?
• What, if anything, is the difference between data integration and data transfer?
• Can we imagine a world where the IRT functionality isn’t the centre of the universe, but rather it’s integrated in other core technologies at clinical sites? The “big IRT” companies will say no, but the smaller ones are already doing it with much success.
  
  

The integration of generative AI tools presents a transformative opportunity for clinical trials. This talk explores the capabilities and implications of utilizing generative AI to streamline critical processes in the creation of clinical IRT systems, including requirement document creation, test plan generation, code development, and the automation of test case and test matrix creation with real life examples. Leveraging generative AI tools for clinical trial systems software development presents promising benefits in terms of efficiency and productivity. There are risks associated with bias and inaccuracy, so the need for human oversight must be managed carefully. We must strike a balance between automation and human expertise, ensuring that the use of generative AI tools aligns with the ethical and regulatory standards of the clinical trials industry.

Join us for a pivotal presentation titled "Transforming Clinical Trials: Harnessing the Power of Technology and Data." This session will explore the dynamic intersection of technology and clinical trials, emphasizing the critical role of Randomization and Trial Supply Management (RTSM) in optimizing clinical operations.

Led by industry expert Jeff Rubesin, this presentation will delve into the complexities and fragmented processes inherent in clinical trials. Attendees will gain valuable insights into how technological advancements, including AI and cloud computing, are revolutionizing data management and trial efficiency.

Key takeaways will include strategies for implementing robust data architectures, integrating diverse data sources, and utilizing generative AI to boost productivity. Learn how to navigate the regulatory landscape while adopting cutting-edge technologies to drive successful clinical trials.

Don’t miss this opportunity to stay ahead of the curve and transform your approach to clinical trials with actionable insights and practical solutions. Secure your spot to discover how Endpoint Clinical is setting new standards in the clinical research landscape.

Join us for an invigorating quick paced session where industry leaders are presenting 15-minute flash talks on specific technologies being applied in IRT/Clinical Supply Chain, presenting data to demonstrate efficacy.

• Robotic Process Automation (RPA) - Derek Thornton, Associate Director, Clinical Systems (IRT), Amgen, USA
• DCTs and IRT - Zachary Smith, Senior Research Analyst, Tufts CSDD, USA
• Tracking & Forecasting – Maxime Derep, Senior Solutions Engineer, N-Side, Belgium
• Integration - Romayne Brecht-Golderer, Associate Director of Clinical Data Management -eClinical Technologies, IRT Oncology Program Lead, Merck, USA