Bridging the Remote-to-EDC Gap: Integrating DHTs Without Violating GCP
Date: June 11, 2026
Duration: 60 Minutes
Time: 12 PM EST
Following the FDA’s March 2026 Request for Information regarding Digital Health Technologies, the mandate is clear: remote monitoring data must be as robust, traceable, and secure as site-generated data. Sponsors are eager to leverage DHTs and wearable data to enhance patient engagement and accelerate timelines. However, the disconnect between external data streams and legacy Electronic Data Capture (EDC) systems leaves many clinical programs vulnerable to data-integrity findings, transcription errors, and costly delays.
Join us for a focused, 60-minute masterclass designed to help you navigate this integration gap without compromising regulatory compliance.
Why Should You Attend?
As the clinical trial landscape rapidly evolves with the integration of digital health technologies, falling behind on regulatory standards can lead to costly delays and data integrity findings. By attending this webinar, you will gain a competitive edge by learning how to bridge the gap between remote data streams and legacy systems. This session goes beyond theory to provide actionable, reviewer-ready strategies that safeguard your trial data and streamline e-submissions. You will leave with a clear roadmap to ensure 21 CFR Part 11 and GCP compliance, allowing you to modernize your clinical operations with confidence. Don’t miss this opportunity to leverage two decades of regulatory expertise and transform how your organization handles external data streams.
What You Will Learn
During this session, our industry expert Dr. Mukesh Kumar will break down actionable strategies to ensure your clinical trials remain fully compliant with 21 CFR Part 11 and GCP standards.
- Decoding the 2026 FDA RFI: Understand how the agency evaluates decentralized data and what inspectors look for in sensor-derived endpoints.
- Overcoming the Remote-to-EDC Disconnect: Learn how to unify siloed vendor platforms with traditional EDC architectures.
- Securing Data Pipelines: Discover best practices for end-to-end encryption, unalterable audit trails, and automated data ingestion.
- Inspection Readiness: Ensure that your digital data packages are reviewer-ready from Day 1.
Who Will Benefit
This masterclass is designed for clinical trial and regulatory leaders, including the following specific designations:
- Chief Technology Officers (CTOs) and IT Directors
- Vice Presidents and Directors of Clinical Operations
- Clinical Data Managers and Data Scientists
- Regulatory Affairs Directors and eSubmission Leads
- Compliance Directors and GCP/21 CFR Part 11 Auditors
- Quality Assurance (QA) Managers
Your Expert Speaker
Two Decades of Regulatory and Clinical Excellence
This webinar is led by Dr. Mukesh Kumar, a senior FDA consultant and clinical trial specialist with 20 years of intensive experience in IND preparation, e-submissions, and electronic Common Technical Document (eCTD) publishing. With an extensive track record of guiding sponsors through complex FDA meetings and clinical data operations, the speaker ensures your data pipelines are designed to withstand FDA scrutiny.
Webinar Agenda
- The New Regulatory Imperative: Breaking down the late-March 2026 FDA guidelines on DHTs.
- Identifying the Architecture Gap: Overcoming the disconnect between remote devices and legacy EDC systems.
- Structuring Seamless Submissions: Proven frameworks for 21 CFR Part 11 and GCP-compliant data pipelines.
- Live Q&A: Bring your most complex data integration and compliance challenges to our experts.
Each attendee gets a 15 minutes FREE Ad-Hoc Consultation after the webinar.
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
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
We accept credit card, debit card, and PayPal.
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.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
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.
