Technology-enabled decentralized clinical trials (DCTs) involve the use of wearable biosensors and other digital tools that allow participants to perform many trial activities and assessments virtually from home. For most trials, decentralized activities include completing informed consent procedures, virtual doctor visits, periodic vital sign assessments and continuous monitoring of activities, sleep or behaviors. The operational complexities of managing multiple remote technologies can be overwhelming.
Join this webinar with key opinion leaders as they define what “decentralized” really means from the perspective of study participants, sponsors and contract research organizations (CROs). The featured speakers will discuss the role wearable biosensors play in the future of clinical trials — from basic measurements to advanced behavior-monitoring algorithms and the necessary science behind the accuracy of wearable biosensors. Lastly, the featured speakers will share information about resources and expert communities that exist to help sponsors and CROs navigate the complex world of DCTs.
Speakers
Jeremy Wyatt, CEO, ActiGraph
Jeremy Wyatt is the CEO of ActiGraph, a leading global provider of physical activity and sleep monitoring solutions for pharmaceutical and academic industries. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective on the challenges and opportunities of deploying wearable technologies to capture accurate and meaningful patient data.
He is considered an industry thought leader and expert in the clinical biosensor space and is a frequent representative and contributor at clinical drug development commercial events, scientific consortiums and FDA/EMA regulatory meetings. He has an undergraduate degree in electrical engineering from the University of Florida and an MBA from the University of West Florida. Jeremy is a member and contributor to the Digital Medicine (DiMe) Society and participates in various digital biomarker efforts with the Clinical Trial Transformation Initiative (CTTI).
Message Presenter
John Reites, Co-Founder and CEO, THREAD
Executive intrapreneur turned digital health entrepreneur, his career spans nearly 20 years leading global drug development, digital health and decentralized clinical trials (DCTs) for life science organizations.
As Co-founder and CEO of THREAD, John leads the global organization to achieve its 1/5/30 mission to modernize clinical research by offering biopharma and CRO customers one (1) comprehensive platform that is five (5) times more inclusive and makes research 30% more efficient.
Message Presenter
Keith Wenzel, Senior Director, Business Operations Scientific Data Organization, Parexel
Mr. Wenzel has worked for Parexel for over fifteen years. His background includes product, corporate and personnel management; sales and marketing; and information systems experience. These skills have been applied within the life sciences and health care industries through working with and for clinical trial sponsors, contract research organizations and technology partners. His areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials.
Mr. Wenzel holds the position of Senior Director within Parexel’s Scientific Data Organization, a team that brings innovation to clinical trials by utilizing real-world data. He is responsible for advising clinical trial sponsors and consults with regulatory authorities and industry organizations to advance the knowledge of RWD, eClinical, eCOA, sensors/remote medical devices and their application in clinical trials. Mr. Wenzel is a member of core committee for the Drug information Association’s (DIA) Study Endpoints Community. He was a member of the program committee for the DIA’s Annual Meeting from 2012 to 2015 and in 2021. He has been on the program committee for all three of the DIA’s Study Endpoints-centric conferences as well as DIA’s 2020 Digital Technology in Clinical Trials
Message Presenter
Craig Lipset, Co-Chair, Decentralized Trials & Research Alliance
Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University. Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures
Message PresenterWho Should Attend?
This webinar will appeal to executives, directors, scientists and managers from pharma, biotech and contract research organizations (CROs), including:
- Research and Development
- Clinical Operations
- Clinical Science
- Digital Innovation/Strategy
- Clinical Trial Planning and Optimization
- Medical Affairs
What You Will Learn
Register for this webinar to learn about the:
- Differences between fully centralized, hybrid and fully decentralized study designs
- Digital tools and technologies commonly used to support DCTs
- Stakeholder perspectives on DCTs — participants, sponsors and CROs
- The position of the US Food and Drug Administration (FDA) on digital health technologies and label claims
Xtalks Partner
ActiGraph
ActiGraph’s mission is to bring life to digital data. Built on more than twenty years of remote data capture expertise, ActiGraph is the leading provider of medical-grade wearable motion sensors for the global scientific community. ActiGraph’s FDA-cleared biosensors and flexible technology ecosystem deliver high quality, continuous digital data, providing valuable insights into the real-world behaviors of clinical trial participants. Appearing in more than 17,000 published scientific papers to date, ActiGraph is the industry’s most experienced, knowledgeable.
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