Innovative Medicines Initiative Blockchain Project, PharmaLedger, includes 29 public and private partners. Overview of the 3-year project and the development of the selected use cases in the area of supply chain, healthdata marketplace, and clinical trials.

If they become a bottleneck, supply chain, manufacturing or budgets can delay clinical trials and slow down research. With an experience of over 10.000 optimized trials and programs, N-SIDE shares a path towards faster commercialization, through measurable drug waste and budget reductions enabled by end-to-end clinical supply chain optimization. These concepts will be illustrated by a case study throughout the presentation.

We will give an introduction to Novo Nordisk’s ambition for “Hands-off Clinical Supply Chain” and discuss our learnings and challenges from implementing processes which are increasingly supported by digital solutions. Our continued journey includes navigating between waves of technology hype and a reality where employees also need to get on board to harvest the benefits of automation and digitalization.

Self-attention based neural networks are able to predict successive words given a linguistic sequence. Historical shipping measurements can also be understood as the context of a sequential story in which the next word represents the predicted value. For the first time, we combine enrollment data, manufacturing request data, and historical shipment data to forecast future shipments to clinical sites using a linguistic approach.

Recently, IRT and temperature excursion management have become integrated solutions with one another as sponsors seek to reduce risk in their studies. This talk will explain how IRT can help sponsors manage risk in temperature excursion management more effectively. It will also explain how companies can plan to effectively integrate digital and automated processes into their workflow for optimal benefit to all parties involved as quickly as possible.

While personalized medicine is transforming patient outcomes, it also represents a challenge to patient privacy and data security. This is especially true for cell and gene therapies and organ transplants, which involves the collection, use, and transfer of personally identifiable genetic information about donors and recipients. Ben Taylor discusses the challenges in the space and how blockchain ensures data security and regulatory compliance for all stakeholders.

The current, industry-standardized means of monitoring temperature at clinical sites consist of several manual steps most often performed by the clinics' study staff. The consequences of these manual endeavors result in both unwanted temperature excursions and data gaps in the temperature monitoring process. We will discuss how technology is being applied to create a seamless process that ensures the timely collection of complete and high-quality data, facilitates de-centralized studies, and greatly reduces site and study teams' burden.

Cmed Technology CTO, Dr. Tim Corbett-Clark shares his views on the current landscape within clinical trials, discussing the challenges that point and unified solutions bring. He also examines how to best optimize clinical trial data workflows by bringing the tech to data, removing the silos, and eliminating the barriers to getting holistic data for total control and visibility from phase one to four.

Overview of the Clinical Trial Solutions at Tempus which support precision patient identification and recruitment for oncology clinical trials through the TIME Trial program, a rapid activation Just-in-Time network of research-experienced clinical trial sites

Watch a live demonstration of protocol design utilizing real-world data on the TriNetX platform for a phase III cardiovascular randomized controlled trial, and a subsequent label expansion.

Traditional Clinical Trial Management Systems (CTMS) are often time consuming and costly implementations and not an ideal fit for many sponsors that outsource their clinical monitoring. As organizations grow and expand their pipeline, creating real-time visibility to trial and site performance versus relying on feeds from partner CTMS systems becomes a higher priority. This talk explores the “right-size” Clinical Trial Management System for growing organizations. What operational data should be owned and managed internally and provides the greatest value and insights.

By integrating centralized data review systems together, AbbVie's clinical data review platform provides a one-stop-shop for all clinical data activities, encompassing study start-up, conduct, and close-out, and resulting in increased efficiency and compliance. This intuitive, robust, and scalable platform enables automation where possible to drive speed, agility, and quality. Utilizing this new platform eliminates the need for manual trackers, closes the gap between plan and execution and further drives team collaboration.

An interactive analytics platform will be showcased that provides cross-functional stakeholders direct access to clinical data allowing for easy study monitoring, on-demand insights, and agile decision making. These solutions are deployed for early development Oncology clinical trials to promote rapid and repeatable consumption of the data and enable go/no-go decisions.

Founded in 2006, Highthinkmed is the fastest growing clinical CRO in China with over 800 full time employees, providing one-stop clinical services including clinical operation, medical affairs, data management, biostatistics, pharmacovigilance, regulatory affairs etc. Highthinkmed owes its own eCTD system meeting requirements of FDA, EMA and NMPA with a professional team providing eCTD submission services. Highthinkmed welcomes all partners across the world for international collaboration.

Different endpoints derived from wearables can require very different wearable sensors.  Unfortunately, qualifying and integrating different wearables often from different vendors can be time-consuming and uncertain.  Learn how Shimmer Research is addressing this challenge by introducing a series of wearables that are all part of its highly flexible Verisense platform.