WHO WE ARE

The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

 

NEWS FROM THE ECF

eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”

Webinar: Thursday, 16-November-2023 

eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”

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. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

Select recordings available

eCF "Birds-of-a-Feather" Round-table Discussions, Presentations and Technology Showcases 2020 to 2022

“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together.  Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

Requirements for Regulated Electronic Data in Clinical Trials and the Site eSource-Readiness Assessment

eCF Webinar on "eCF Requirements" and "eSRA" - Recording Available Here

This webinar recording provides the same content as was presented to the FDA CDER Health IT Board on 6-April-2021

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

Recording: Use of eSRA to fulfill Sponsor responsiblity for assessing site systems

Birds-of-a-Feather Webinar & Discussion: Investigator Oversight on eCOA data - what is a good evidence?

January 29 2020; facilitated by Cinzia Piccini of Eli Lilly

Birds-of-a-Feather Webinar & Discussion:  Investigator Oversight on eCOA data - what is a good evidence?

As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period.  The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.

 

MEMBERS: Birds-of-a-Feather and Tech Showcase Recordings

  • 25 July 2017
  • Author: Webmaster1
  • Number of views: 1
  • 0 Comments

Selected events are recorded and are available un-edited for member use only within the "BoF & TS Recordings" folder below.  Not all events will be recorded or released. Recordings are un-edited and are provided for eCF member use only.  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.

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Event Feedback

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event
We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.

Electronic Informed Consent Technology Showcase - An Excellent Event

Event Feedback

  • 30 November 2016
  • Author: Webmaster
  • Number of views: 14751
  • 0 Comments
Electronic Informed Consent Technology Showcase - An Excellent Event

We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.

Adoption of Cloud Technology in the Regulated Life Sciences Industry

An eCF BoF Webinar presented by PhUSE

  • 27 September 2016
  • Author: Webmaster
  • Number of views: 12773
  • 0 Comments
Adoption of Cloud Technology in the Regulated Life Sciences Industry
PhUSE kindly presented their framework for the adoption of cloud technology in the regulated life sciences industry. The session was attended by 70 members from 24 companies in 14 countries. Expand the article to read more about the topic and discussion

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eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.

 

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Japanese translation of eSRA V2023

Japanese translation of eSRA V2023

Version 2023.2JP1 (18-Sep-2023)

Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)

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Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.

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eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

Read more
5
eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

Read more
6
eClinical Forum Hybrid Workshop, Barcelona, Spain

eClinical Forum Hybrid Workshop, Barcelona, Spain

We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems

This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.

We encourage you and your colleagues to REGISTER NOW

Download Agenda HERE

Read more
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