While bring-your-own-device (BYOD) has been in use for years, the pandemic has accelerated wider acceptance with the shift toward decentralized clinical trials and the intensified need for robust, patient-centric clinical trial solutions. Since smartphones are central to patients’ lives, incorporating them into clinical trials is a logical step toward more reliable and less burdensome electronic patient-reported outcomes (ePRO) collection.
The benefits of using a scientifically proven, bring your own device (BYOD) or hybrid solution include:
- Increased patient recruitment
- Increased patient retention
- Better patient experience
- Greater compliance
- Higher-quality data
- Lower costs
- Shorter build timelines
With all these benefits of BYOD and the recent technological advances that have taken place, regulatory, logistic, data privacy and security questions remain. What sort of documentation will the FDA require to support BYOD-derived data? Does BYOD adequately protect patient data? Will BYOD work for a global Phase III study?
Register for this webinar to hear experts address these considerations, as well as help clinical trial sponsors develop a clear path to use BYOD.
Speakers
Jonathan Andrus, Chief Business Officer, Clinical Ink
As Chief Business Officer, Jonathan Andrus leads Clinical Ink’s solution management and commercial teams to help sponsors and CROs better leverage DDC, eCOA, and ePRO data. With more than 20 years of experience, Andrus has extensive expertise developing eClinical services that integrate data and technology to help life science companies optimize study execution. Andrus is responsible for P&L across Clinical Ink’s products and services, and forging strategic partnerships with sponsors, CROs, regulatory bodies, and clinical research professionals.
Andrus joined Clinical Ink from BioClinica where he led the eClinical Solutions Group to develop their current service offerings, including data management, quality management, implementation services, and IWRS. Prior to BioClinica, Andrus worked in pharmaceutical consulting and with CROs focused on quality, data management, and validation.
Andrus served as chair of the Society for Clinical Data Management in 2008 and 2013 and currently serves as the society’s Treasurer. He is also an active member of DIA.
Message Presenter
Willie Muehlhausen, Chief Executive Officer, Safira Clinical Research
Willie Muehlhausen graduated from vet school in Berlin, Germany, in 1996, and joined the clinical research industry as data manager in a large CRO in 1998. His first project in data management included a paper patient diary, and this started his interest in PROs. By 2002, he managed his first ePRO study, and after a couple of years in the U.K. and the U.S., he joined an ePRO provider in 2004. Working alongside the leading scientists in the industry sparked his interest in patient behavior and how ePRO can support patients in clinical trials.
Today, with additional experiences from being the head of innovation at another large CRO and working as an ePRO product manager, Willie is an accomplished, award-winning researcher, author, innovator, and mentor, driving eCOA BYOD research to support patients´ choice in the method of eCOA data capture. His team´s research and publications have forged a path for implementing and migrating instruments on patients´ devices without compromising instrument validity. Willie is now co-founder of Safira Clinical Research, a boutique CRO specializing in providing eCOA services and consulting to technology partners and biopharmaceutical and medical device companies.
Message PresenterWho Should Attend?
This webinar will appeal to individuals with the following, or related, job titles:
- ePRO/ePRO Category/Data Managers
- Clinical Trial/Clinical Study Leads
- Clinical Operations Specialists
- Clinical Operations Directors/VPs
- Therapeutic Strategy Leads
- Biometrics/Bio Stats Managers
What You Will Learn
In this webinar, participants will learn about:
- How BYOD benefits the clinical trial’s most important asset: the patients
- The latest regulatory guidance around decentralized clinical trials and BYOD
- How BYOD improves data management, quality and time to database lock
- The operational benefits of a BYOD model for sponsors and CROs
- Why BYOD is a key component of the “next normal” in clinical trial design
Xtalks Partners
Clinical Ink
Clinical Ink is a global clinical technology company offering data certainty from source to submission via our Lunexis™ eSource platform and configurable ePRO, eCOA, direct data capture (DDC), and eConsent modules. This suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source naturally enhances clinical trial workflows. For virtual, traditional, or hybrid trials, Lunexis technology reduces manual labor and provides anytime, anywhere data access, saving resources as trials progress. Visit clinicalink.com.
Safira Clinical Research
Safira Clinical Research is a boutique clinical research organization with a focus on patient-facing technologies. We provide services to eCOA, IRT/RTSM, EDC, wearable device technology providers, and bio/pharmaceutical clients. Our team of specialists with decades of experience in these areas help new technologies to come to market faster with a more robust product. We provide services (i.e., license management, client UAT, validation) to complete the offering. Sponsors benefit from our experience when they assess the eCOA market and individual vendors. We provide operational eCOA management support as well as scientific research and consulting. Visit safira.partners.
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