Scaling Up eConsent in Traditional and Decentralized Clinical Trials (DCTs)

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Patient Recruitment & Retention, Drug Discovery & Development,
  • Tuesday, June 08, 2021

If the recent pandemic taught us anything, it is that clinical research can deliver effective treatments quicker by adopting the right technology. Case in point: Electronic informed consent (eConsent). The digital solution streamlines the entire consent process, can support large portfolios, and enables decentralized studies.

Register today for the webinar and discover:

  • How different models of electronic consent solutions enable effective and efficient scale up across all studies and phases as well as accommodate different patient populations in both traditional and decentralized clinical trials
  • Solution properties that enable easy transition from pilot to use at scale
  • Sensible approaches to compliant adoption of remote consenting and the role of telemedicine
  • How to migrate from a paper-based form to an electronic consent process, and how to work eConsent into existing trials workflows
  • Best practices for managing global eConsent/reconsent for traditional, remote or hybrid trials
  • Important regulatory considerations related to eConsent usage including electronic signature acceptance, privacy laws and regulatory-compliant, traceable audit trails
  • How to optimize workflows through integrating eConsent with other digital solutions to simplify activity, improve data quality, and enhance decision making
  • Learn the rationale and approach one sponsor is taking in scaling up eConsent usage across their organization: Edwin Cohen from AstraZeneca will discuss the pharmaceutical company’s rationale for scaling up, their adopted processes, and how eConsent fits within their eClinical technology infrastructure

Whether you are curious about using eConsent or need tips to scale up, register for this free webinar to learn from some of the industry’s top experts.

Register today to hear why eConsent is the future of clinical trial research.

Speakers

Edwin Cohen, Digital Health R&D, AstraZeneca

Edwin Cohen is currently part of the R&D Digital Patient Health & Innovation organization within AstraZeneca which focuses on adopting digital tools & initiatives to improve patient outcomes by providing new medicine and complimentary therapeutics to the right patient, faster. One of the key responsibilities now is the global implementation of eConsent. Edwin has worked within the pharmaceutical industry for over 15 years in various local and global clinical operation roles. The last couple of years have been focussed on the global informed consent process and the development of a new patient app that will improve patient clinical trial experience and outcomes.

Message Presenter
http://Ryan%20Bowe,%20Signant%20Health

Ryan Bowe, Head of Regulatory Compliance, Signant Health

Ryan Bowe serves as the Head of Regulatory Compliance at Signant Health and s erves as a contributing member of the eClinical Forum’s Regulatory Expert Group, where he works with other regulatory experts in the clinical research industry to develop tools to harmonize requirements for computerized system validation and qualification for use in clinical trials throughout the world.

Message Presenter
http://Mika%20Lindroos,%20Signant%20Health

Mika Lindroos, Director of Product Management, Signant Health

Mika Lindroos is the Director of Product Management at Signant Health. With over two decades of experience in global software product management, Mika’s breadth of experience spans from product and portfolio management, strategy and business development, in addition to heading a product line at Nokia to revenue and business relationship development at Digia Pic.

Message Presenter
http://Dr.%20Bill%20Byrom,%20Signant%20Health

Dr. Bill Byrom, Principal, eCOA Science, Signant Health

Dr. Byrom serves as Principal, eCOA Science at Signant Health.  He has worked in the pharmaceutical industry for 30 years and authored over 70 publications as well as two industry textbooks on electronic patient-reported outcomes (ePRO). His recent scientific work focuses on the use of wearable technology and bring-your-own-device (BYOD) in eCOA in clinical trials.  He currently serves on two ISPOR task forces related to clinical outcome assessments, and leads a cross-industry team on leveraging wearable technology for clinical trial endpoints with the DIA Study Endpoints Community.

Message Presenter

Who Should Attend?

  • Clinical Operations
  • Clinical Innovation
  • Clinical Technology
  • Data Management
  • Medical Director/Clinical Sciences
  • Patient Recruitment
  • Academic Research
  • Clinical Site Management
  • Executive Leadership
  • Health Economics
  • Outcomes Research
  • Regulatory/Risk Management
  • Quality Assurance
  • Outsourcing/Vendor Relations/Procurement
  • Adherence and Compliance

What You Will Learn

  • The eConsent basics: the solution properties, how it works, and why it improves the clinical trial efficiencies
  • Tips to adapt current workflows to modernize with eConsent
  • Best practices for managing electronic consent/reconsent on a global scale
  • Optimization benefits of integrating eConsent with eClinical tools/applications
  • Real-world example: AstraZeneca’s experience using eConsent within their eClinical technology infrastructure

Xtalks Partner

Signant Health

Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, RTSM, supply chain management, and data quality analytics. Learn more at www.signanthealth.com.

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