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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 Views & News

February 2025

eCF Views & News

 eCF Views: New thoughts from your fellow eCF members … what do YOU think?

    • What is the definition of a Triple-blind study vs definition of a Double-blind study?
    • How should we handle privacy data that are in audio recordings (e.g. eConsent)?
  • Post your thoughts! None are too narrow or too broad. Just  login to the  Discussion Forums (eclinicalforum.org)  … You will need a member account to login … but it’s easy to get one .. register via  Home (eclinicalforum.org).

  eCF News:

  • eCF 25th Anniversary Fun-Fact: In 2000, we were called the “EDC Forum” and started in Europe with 11 pharmaceutical companies and 8 “allied associates” from the vendor/service industry. Over the years, many were acquired or merged, but 8 of the original founding members are still members in 2025: Bayer, Eli Lilly, Johnson & Johnson, Medidata, Novartis, Novo Nordisk, Oracle (acquired our founding member Phase Forward), Pfizer (merged with our founding member Pharmacia).  Now, 25 years later, the eCF has grown to include 2700+ participants from 62 organisations in 36 countries. Want to know who are members now? See our graphic on the Membership page:  Membership  eCF, Going strong!
  • “How to get the most out of your eCF Membership 2025” slides are available from our website: Downloads, and a recording of the webinar given on Jan 9th is available in the Members section of our website: Getting the most out of your eCF Membership > Webinar Recordings. Of course, if you want to discuss details of your organisation’s membership, your eCF facilitators are happy to discuss (see below for contact information).
  • February is a very busy month for eCF! Check out these events (These are eCF members-only events and are gratis to anyone from an eCF member organisation.):
    • Feb 5, 2025: Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping. This technology showcase will be presented by Achilleas Zaras of eClinical Solutions at both UTC 0800 and UTC 1700 and recorded.  To register, please contact Suzanne.Bishop@eClinicalForum.org.
    • Feb 6, 2025 (rescheduled from 16-Jan-25): eCF “Think GCP” webinar on ICH E6 R(3). This presentation will be given by Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3). This will occur at 2 times: UTC 0900 and UTC 1600. This webinar will not be recorded, so please encourage your colleagues to block out their calendars and join us! (Note, this webinar is for those in eCF member companies only.) To register, please contact Suzanne.Bishop@eClinicalForum.org.
    • Feb 20, 2025: Webinar: Audit Trail Review – Is your Audit Trail fit for purpose? Given by Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM) at UTC 15:00 (NYC 10am; Brussels 4pm; Mumbai 8:30pm; Beijing 11pm). eCF members can register by using this link:  eCF Webinar: Audit Trail Review
  • And this one in March!
  • Mark your calendars for the eCF 2025 Spring workshops!
    • Americas workshop – April 29-May 1, kindly hosted by CSL Behring near Philadelphia, Pennsylvania, USA (This workshop is in-person only.)
    • European Hybrid workshop – May 13-15, kindly hosted by Pfizer near London, UK (This workshop will be in-person and live-streamed and is gratis to anyone from an eCF member organization.)
    • Additional information: eCF Spring 2025 Workshops Announced.   More information will also be sent to eCF members soon!
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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.

The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.

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eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

Presenter:        Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic:  The final piece of the GCP renovation puzzle, revision 3 of ICH GCP.  Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.

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eCF Webinar:  Audit Trail Review – Is your Audit Trail fit for purpose?

eCF Webinar:  Audit Trail Review – Is your Audit Trail fit for purpose?

Date:                Thursday, February 20, 2025      Duration: One hour

Presenter:       Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM)

Dr Torsten Stemmler has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.

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