This electronic clinical outcome assessment (eCOA) webinar will explore the latest advancements in wearable technology and their potential to improve patient data collection in clinical studies. While there may still be ongoing discussions around deployment and standardization, it is clear that newer technologies such as accelerometers and video have the ability to passively or proactively gather more patient data. These wearable devices offer significant advantages in terms of capturing comprehensive and detailed information, ultimately informing the safety and efficacy of study drugs.
In this webinar, the featured speakers will take a look at the key decision drivers for consideration in deploying wearables as a means to further gather patient data, including both technical hardware considerations and regulatory requirements.
Join this webinar to learn about the benefits and considerations of utilizing wearable devices for improving eCOA patient data capture in clinical trials.
Key Takeaways:
- eCOA trends including wearables
- Wearable hardware: What does the ISO-13485:2016 certification mean and are all devices certified?
- Is the 510K registration required?
- Considerations for implementing wearables with the current eCOA strategy
- Alarms and alerts considerations for including them into current eCOA solution
Speakers
Mark Wade, Global Practice Leader, TransPerfect Life Sciences, COA SME
Mark P. Wade holds the position of Global Practice Leader at TransPerfect Life Sciences, the largest Language translation company globally, where he is the resident SME for all clinical trial processes and translation. Mr. Wade’s 20 years in life sciences includes International Regional Director for EMEA at Ethicon and Ethicon Endo Surgery, Johnson & Johnson companies (NYSE: JNJ). For almost 10 years Mr. Wade was the Global Practice Leader at another global language translation company. He is a published expert in electronic clinical outcomes assessments (eCOA) including two ebooks, clinical posters and numerous articles in trade journals. He has significant experience and has published in clinical services, patient recruitment and site selection.
Mr. Wade has chaired, presented and published posters at DIA Annual Symposia and numerous other internationally recognized conferences. He is an active committee member of C-Path eCOA Consortium, ISOQOL Translation & Cultural adaptation (TCA) Special Interest Group (SIG), ISPOR TCA SIG and DIA Endpoint Study Group.
Message Presenter
Sylvain Zorman, Director of Digital Health Sciences, ActiGraph
Sylvain Zorman is the Director of Digital Health Sciences at ActiGraph, where his primary focus is on developing partnerships with academia and pharmaceutical companies and engaging with regulatory agencies to advance the field of digital health. With a degree in engineering and PhD in biophysics, Sylvain brings a unique perspective to his work, combining a multidisciplinary approach with a deep understanding of the complexities of digital technologies. In his previous role as Digital Solution Lead at Novartis, he was responsible for developing and implementing digital endpoint strategies for large-scale clinical trials in therapeutic areas such as immunology and gene therapies
Message Presenter
Kyle Hogan, President, Datacubed Health
Kyle has been dedicated to advancing the voice of the patient through the promise of ePRO/eCOA since 2007, helping to deliver more than 500 successful trials for CROs and pharmaceutical companies globally. He is a recognized expert in implementing innovative and patient- centric ePRO/eCOA solutions with an aim to achieve sponsor confidence and study success across all phases of clinical trials.
Message Presenter
Lorcan Walsh, Digital Endpoint Capability Centre Lead, GDD Clinical Development Excellence, Novartis
Lorcan Walsh, Ph.D. leads the Digital Endpoint Capability Centre in Novartis’ Global Drug Development function. He has developed and implemented digital health technologies for over 15 years across academia and industry. In his current role, Lorcan leads a team of digital endpoint specialists to embed and elevate novel endpoints using digital health technologies in large scale clinical trials.
Lorcan graduated with a PhD in Biomedical Engineering, and has a First Class Honours degree in Communications Engineering (first in class). Lorcan is a Fulbright Alumnus having undertaken part of his doctoral research in the Division of Sleep Medicine, Brigham and Women’s Hospital & Harvard Medical School.
Lorcan is the Founder of TEDxFulbrightDublin and co-lead of Health 2.0 Dublin.
Message PresenterWho Should Attend?
Key decision makers looking to deploy a decentralized clinical trial:
- Study Leaders
- Clin Ops
- eCOA vendors
- Localization eCOA providers
What You Will Learn
Attendees will gain insights into:
- Electronic clinical outcome assessment (eCOA) trends including wearables
- Wearable hardware: What does the ISO-13485:2016 certification mean and are all devices certified?
- Is the 510K registration required?
- Considerations for implementing wearables with the current eCOA strategy
- Alarms and alerts considerations for including them into current eCOA solution
Xtalks Partner
TransPerfect Life Sciences
TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact. For more information, please visit our website at https://lifesciences.transperfect.com/.
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