Wearable Sensors in Clinical Trials: Data System Integrity

Digital health technologies, including wearable sensors, are being considered as solutions that will revolutionize clinical trials, deliver clinically meaningful endpoints, reduce study costs, and engage patients. However, for all this to take place, the data collected must be trustworthy; the systems in place should be robust; and the sensor deployment, data collection, compliance monitoring, data aggregation, data analysis, and delivery should be auditable and secure.

Platforms designed to manage these data are usually sensor-specific and tightly controlled, reducing the opportunities for scalability, optimization and sometimes even validation in an industry in which many of these technologies and measures are still experimental and not clinically validated. To really take advantage of this revolution, a platform that can incorporate data from different technologies, harmonize these data and deliver them within a study is required.

In this presentation, a panel of stakeholders from different perspectives (technology, pharmaceutical industry, and digital health) discuss data system requirements to deliver digital health technologies with high integrity and trust, including:

  • The importance of considering the data strategy early in the protocol development stage.
  • Being aware of siloed data -  consider carefully how the data must flow to all stakeholders. 
  • The importance of tracking and cleaning data streams.
  • Collaborating with the right partners and aligning on the requirements to work with sponsors, regulators, and digital health technology providers. 

Expert Panelists

(Moderator) Dudley Tabakin, Chief Product Officer, VivoSense Inc.

Dudley TabakinDudley Tabakin, is cofounder and Chief Product Officer at VivoSense, with a dedication to delivering quality data from digital health technologies in clinical trials. With more than 25 years experience in the biomechanics and wearable technology industries, Dudley understands the pivotal role of accurate and reliable data in driving meaningful insights. This steadfast commitment to excellence has positioned VivoSense as a trusted leader in the development of novel digital measures, empowering clinicians and researchers alike with unparalleled access to precise and actionable data for improving patient outcomes and advancing research.

Stijn Rogiers, Head Data Integration and Standards, Argenx

Stijn RogiersStijn Rogiers joined argenx in June 2022 as Head Data Integrations and Standards (Data Management). Argenx is a fast-moving and growing Biotech company. Stijn has 20+ years of experience both at CRO, Pharma industry and Technology. He worked 5 years at SGS Life Sciences (CRO), 10 years within Janssen (Johnson & Johnson) and 7 years at SAS Institute (analytics leader) before moving to argenx. Stijn is also a member of the European CDISC Coordinating Committee (E3C).

Anders Strömberg, Director, Head of the Health Solutions Division, Sony Network Communications Europe

Anders StrömbergAnders Strömberg heads a business entity within Sony that provides connected solutions leveraging 4G/5G IoT communication technology for application areas such as mobile health and safety. The vision is to be a facilitator and front-runner for next-generation digital biomarker solutions.

Anders has a background from the med tech industry and has worked in several major companies, among them Hewlett-Packard, Siemens and HemoCue. Anders has also experience from the telecom and cybersecurity industry, where he has worked in several start-up companies providing application platforms, application and consulting since 2000. This includes companies like Advenica, Appium/Aepona, MIMT, Heyhop, Bluelabs and moveAround. Andes has held management functions within business development, R&D and product management.

The Health Solution Division was established in 2019 as a result from an innovation competition within Sony and is driven by Anders.

Sandip Bharati, Head of Software Engineering, VivoSense, Inc.

Sandip BharatiWith over two decades of experience in healthcare technology and software engineering Sandip Bharati serves as the Head of Engineering at VivoSense. Sandip is driving the strategic design and development of an innovative, scalable, and highly secure platform utilizing wearable sensors to help derive novel digital clinical endpoints. His expertise lies in spearheading large-scale analysis of wearable data for biomarkers, facilitating advanced scientific data analysis, and engineering essential tools for the VivoSense science team to derive digital endpoints. Prior to his role at VivoSense, Sandip held pivotal positions at renowned organizations such as Lytx, Inc., Tandem Diabetes Care, Thermo Fisher Scientific, and Qualcomm.

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Dudley Tabakin

Dudley Tabakin

Dudley Tabakin, MSc. is Chief Product Officer and co-founder of VivoSense and a fervent believer in “good data” over “big data" in the development of digital endpoints from wearable sensor technology.

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