FDA Compliant Use of Smartphone, Smartwatch, and Apps in Clinical Trials

Date: June 30, 2025
Duration: 60 Minutes
Time: 12 PM EST

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:
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

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$199

Group Registration (5 Persons)

$699

Group Registration (10 Persons)

$1199

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.