Webinars >>Clinical Trials
FDA Compliant Use of Smartphone, Smartwatch, and Apps in Clinical Trials
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Use of wearable devices is increasing in clinical trials with more than half of the clinical trials employing these devices by 2020. There is scant guidance from FDA regarding regulatory requirements for use of such devices in clinical trials. Wearable and personal communication devices such as Smartphones, tablets, Smartwatches, health-tracking devices make it easy to capture patient reported outcomes (PROs) in real-time using apps. The use of “Bring-Your-Own-Device (BYOD) format has made it more convenient and less expensive for both the sponsors and patients. Even post-approval collection of safety and real world evidence (RWE) for clinical outcomes can be highly facilitated by electronic devices. It is important that developers and sponsors carefully review current FDA requirements to increase acceptability of data collected using such devices by FDA. This seminar will discuss FDA-compliant best practices and tips for successfully using Smartphone, Smartwatch, and other devices in clinical trials.
Why should you attend:
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All clinical trials can benefit from using common electronic devices. If you are planning a clinical trial, you must consider use of wearable or non-wearable devices to capture critical information for your trial. This seminar will discuss all relevant aspects of using electronic devices in clinical trials, FDA rules for such devices, practical concerns, and suggested solutions. The seminar is delivered by one of the country’s leading expert in FDA regulations concerning electronic devices in clinical trials and other regulatory functions. The speaker will share tips and checklist based on industry best practices for using smart devices in clinical trials. Do not plan your clinical trials without this must attend and one-of-a-kind webinar.
Areas Covered in the Session:
  • The kind of applications and devices used in clinical trials
  • FDA expectations from validation, user instructions, monitoring practices
  • Practical concerns with BYOD format
  • Incorporating data captured using smart devices in CRFs and source documents
  • Auditing and monitoring smart device usage in clinical trials
  • Trends in FDA regulations for such devices for pre- and post-market research
  • Using smart devices in multinational clinical trials
Who will benefit:
  • Regulatory affairs personnel
  • Quality assurance personnel
  • Clinical trials personnel
  • Information technology personnel
  • Vice presidents, Directors and Managers
  • People interested in investing in the FDA-regulated industry
Date: April 17, 2019
​Duration: ​60 Minutes
​Time: 12 PM EST

Speaker: Mukesh Kumar
​PhD, RAC | Brij Strategic Consultations,  USA​

    For more info, fill the box below. We will contact you within 24 hrs.
For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com