"This is the best use of my time to remain current with what is going on in the industry."
Event date: 13/08/2025 Export event
Background: eClinical Forum Birds-of-a-Feather webinar sessions focus on the details of a specific topic. All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
For This Topic: This session is not intended to provide firm answers to the below questions. It is about exchanging views with other participants and gaining insights into the different challenges and needs. This is a round-table discussion. Participants are encouraged to share experiences, make comments, ask questions, and contribute to the discussion. To encourage candid discussion, we will not be recording this session
This is a continuation of the eCF eCOA Round table from July 9th (as well as discussions at the Spring workshops), as we had so much discussion that we did not finish all the topics!
This time we will discuss:
Are Sponsoring submitted to FDA, ZQ datasets following the IRT Guidance?
What are the challenges for Sponsor UAT execution?
Reference: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory. FDA Guidance: Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory | FDA
This Round-table will be facilitated by Jeanna Radick and Trish Delong of Johnson & Johns
Anyone from an eCF Member Company may register for this online round-table discussion by sending a note to WEBINARS@ECLINICALFORUM.ORG
eCF Views & News
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(21/10/2025 - 23/10/2025)
(04/11/2025 - 06/11/2025)
(04/11/2025 13:00 - 06/11/2025 15:00)
Registration for the eCF Americas Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Indianapolis, Indiana on October 21-23, 2025.
The workshop will be available for in-person participation only. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14
Registration for the eCF Europe Autumn Hybrid Workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Medidata in London, UK, on November 4-6, 2025
The workshop will be available for both in-person participation and remote access. There will be networking/social events on both evenings. Each eCF Member company can use 1 or 2 in-person seats depending on your membership type and as allocated by your eCF Primary Representative. Remote access of the live-streamed workshop is available gratis to all staff from eCF Member companies. Click to get more information on the planned topics.
Registration for the eCF Asia Autumn workshop is now open!
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.
The workshop will be available for in-person participation only. There will be a networking/social event in the evening. Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here
Technology Showcase: eClinical Solutions: elluminate Assist – AI-driven SDTM study data analysis assistant
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services, and by necessity are not technology or vendor neutral. The eClinical Forum does not promote nor endorse any particular technology vendors. Any member can participate that has an interest in the topic area. Any eClinical Forum Member may suggest or present a Technology Showcase. READ MORE for details on this Technology Showcase.