Tokenization, applied to multi-modal, real-world datasets (RWD), is enabling us to better understand the patient journey. This data is accelerating Long-Term Follow Up (LTFU), Enhanced Regulatory Grade Submissions through External Control Arms (ECAs), and Outcome Validation. Sid will share how Janssen has developed the data, operations, privacy and legal frameworks to leverage this innovative capability to accelerate real-world evidence generation and improve patient lives.

The usage of biosensors – as a subset of digital health capabilities - is becoming increasingly prevalent in Clinical Trials. These technologies allow for continuous data collection, offering a plethora of advantages over the traditional collection of discrete data points. That same continuous data collection also comes with several new questions and challenges: how do we ingest these large amounts of data and how do we best summarize, analyze, report, visualize and archive them?

Medications do not work if you don’t take them. Historically, medication adherence & processes have been a challenge. With the introduction of decentralized trial models, this has become even further convoluted. The need for introducing automation & smart medication technologies has never been more acute. In this session, the speaker will share easy and practical approaches to automate supply activities and provide personalized patient support across traditional, decentralized and hybrid models

The missing link to complete ISF and TMF is the site-owned space that sponsors do not control. Providing a full ISF solution to investigators with no sponsor ownership has been an industry challenge. However, using AI capabilities and easy-to-use workflows provide the necessary tools and efficiencies for site staff to maintain an electronic ISF and selectively share source documents with sponsors.

Clinical Research is evolving to be more technology driven. The Volume, Velocity and Variety of data are increasing rapidly. How can we leverage machines to not just perform repetitive data cleaning tasks but take on higher complexity activities in tandem with humans? In this session we will discuss how AI is transforming Clinical Data Management. We will review a practical DM use case which is adopting state-of-the art AI techniques.

The talk will give an overview of artificial intelligence/machine learning methodologies that can be used for clinical data. The focus of the presentation will be on specific machine learning algorithms used to analyze clinical data, with particular interests in survival analysis. Different case studies involving random survival forest and clustering methodologies will be shown. An overview of the advantages will be presented.

Clinical Trial (CT) and Real World Data (RWD) have been siloed - until now. New advancements are enabling sponsors to link trial patients to their RWD and to accelerate clinical development through better evidence generation across the clinical development lifecycle. Attend this session to learn how and why organizations are “future-proofing” their trials to gain better insights into the patient journey, without sacrificing data security or operational efficiency.

The widely known challenges associated with the planning and execution of trials have been partly exacerbated by the global pandemic, placing additional demands on researchers to identify innovative ways to accelerate and reduce the cost of trials. In this presentation, I'll be reviewing some of the latest thinking behind the use of real-world data in response to this challenge, including the role of electronic healthcare data in “decentralised trials.”

In this session, Sinéad Callinan, Executive Director, Head of Delivery EMEA at THREAD will share her perspectives and best practices focused on scaled adoption of decentralized clinical trial approaches. Topics will include global implementation, the convergence of DCT technology and real-world data, the use of analytics to prove out the DCT value proposition, and the importance of working closely with research ambassador teams, participants, and sites to enable change management.

Two years into the pandemic, it's clear that decentralized clinical trials are here to stay. In this presentation I’ll be exploring the rapid transformation of virtual health solutions, industry trends, operational obstacles and the importance of real world data in the evolving patient journey. Together we will examine components of a patient-focused, flexible supply chain strategy, and how sponsors and investigator sites can benefit from pandemic-era lessons learned.

In the presentation I will demonstrate a real case example on how Lilly co-created a blockchain solution with a start-up company. I will walk through the steps taken and summarize the outcomes on getting real time data and share key learnings.

Most of the applications of wearable sensors have focused on wrist-worn devices.  A whole new world of applications can be developed if the raw data is accessible and the sensors can be placed in different locations.  The presentation describes three novel “off-wrist” applications that are trials today