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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

eClinical Forum Europe Meeting in Paris, France 23-25 October 2018

"Excellent, open discussions on current priority topics"

  • 10/23/2018 - 10/26/2018
  • Author: Webmaster1
  • Number of views: 3439
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eClinical Forum Europe Meeting in Paris, France 23-25 October 2018

That's what one person wrote on the evaluation ... while another wrote "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions" and another wrote "People were amazing. Topics were great. Hosting and events as well." Yes, indeed it was a terrific meeting and we are already planning for follow-up discussions in our project teams, webinars and Spring meetings. Thank you to all who participated!! And a special Thanks for Servier for hosting us. The meeting was attended by: Merck KGaA, ZeinCRO, eResearch Technology, Munich Technical University, Hoffman La-Roche, TriNetX, BSI Business Systems Integration, Orion, Novartis, DBV Technologies, Medidata Solutions, Oracle, CRF Health/Bracket, DMB, Boehringer-Ingelheim, Janssen Pharmaceuticals, Idorsia, Actelion, Ferring, Assistance Publique-Hopitaux de Paris, Wega Informatik, Novo Nordisk, Royal Cornwall Hospitals NHS Trust, 23 Consulting, Neptunus Data, and of course Servier.

eCF North America Autumn Meeting -- Successful Outcome

Oct 2-4 2018 in Philadelphia, hosted by CRF Health

  • 10/2/2018 - 10/5/2018
  • Author: Webmaster1
  • Number of views: 3798
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eCF North America Autumn Meeting -- Successful Outcome

A terrific meeting in Old City Philadelphia was attended by Actigraph, Allergan, Astellas Pharma, Bioverativ, Boehringer-Ingelheim, Bristol-Myers Squibb, Cenduit, CRF Health, CSL Behring, D. Bartley, ConSept Consulting, Edwards Life Sciences, Eli Lilly & Co, ERT, Janssen, Medidata Solutions, Novartis, Pfizer, Rutgers University, Target Health, and Veeva Systems.

Birds-of-a-Feather Webinar: AI and Machine Learning: Applications and Opportunities for Clinical Research

Tuesday, 25 Sept 2018 at UTC 1300 for 1 hour

  • 9/25/2018
  • Author: Webmaster1
  • Number of views: 5636
  • 0 Comments
Birds-of-a-Feather Webinar: AI and Machine Learning: Applications and Opportunities for Clinical Research

Facilitator:    Sheila Rocchio, eClinical Solutions

This webinar discussed “What is AI and Machine Learning”, applications in clinical research both now and in the future, and what skill sets are needed to move this forward. Thank you to Sheila Rocchio for presenting the topic so well. A recording of this webinar is available to eClinical Forum members. Please contact webmaster3@eclinicalforum.org to get access to the recording.

Birds-of-a-Feather Discussion: Considerations When Running Paperless Clinical Trials

11-October-2018 via webinar (one hour)

  • 10/11/2018
  • Author: Webmaster1
  • Number of views: 3995
  • 0 Comments
Birds-of-a-Feather Discussion: Considerations When Running Paperless Clinical Trials

Facilitator:    Dr. Jules Mitchel, Target Health

With drug and device manufacturers and the U.S. Food and Drug Administration (FDA) supplying much of the push, so-called paperless clinical trials are gaining momentum. We will discuss the future landscape and regulatory concerns of paperless clinical trials and clinical trial design incorporating mobile tools.

Birds-of-a-Feather Discussion:  Principal Investigator signature / approval on eCOA Data

Date:  Wed, 25 July 2018     Duration: One hour

  • 7/25/2018
  • Author: Webmaster1
  • Number of views: 2952
  • 0 Comments
Birds-of-a-Feather Discussion:  Principal Investigator signature / approval on eCOA Data

Facilitator: Shelby Abel, Bioverativ a Sanofi Company

For This Topic:   “Experience with exceptions of PI signature/Approval on eCOA Data. Please bring your experience and thoughts.”  This is a facilitated discussion with the content coming from the sharing of participants experiences, comments, and questions on this topic.

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BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

BoF Round-table Discussion: Considerations and challenges for electronic research data archival at sites using direct download

The implementation of new solutions to share electronically the eCRF PDFs with sites have brought up new considerations and challenges to this process.

We would like everyone to share their experiences on how the process has been implemented, as well as the challenges experienced. This will be a group discussion on the recommendations to make this process as straight forward as possible for Sites and Sponsors, while complying with requirements.

Facilitated by Carmen Jiménez, Eli Lilly

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Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1

The eClinical Forum is happy to announce the public release of a position paper titled “Decentralized TMF Archives and The Decommissioning Of Computerised Systems Used In Clinical Trials”.  This position paper was written by a joint task force from EUCROF and the eClinical Forum, with representatives from other industry associations including ECRIN, the ePRO consortium, Medicines for Europe and the RQA.

ABOUT THE POSITION PAPER: Following the completion of a clinical trial, the essential documents that make up the TMF (Trial Master File) are retained and archived by the sponsor, the investigator and, in some cases, sub-contractors to the sponsor and/or investigator. The position paper highlights 11 key positions: seven positions concerning the archiving of the TMF and four positions concerning the archiving of the electronic data. These positions address areas where regulatory expectations are not always seen as being aligned with industry practices.

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Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

Birds-of-a-Feather Webinar: Practical Considerations when implementing eConsent

This webinar introduces the NEW "Practical Guide to eConsent" which addresses key themes and hots topics and provides a view on the modernization of the clinical trials informed consenting process, including the current perception shift of eConsent adoption in light of the COVID-19 pandemic.  This is a joint work by the eClinical Forum and EUCROF.

 

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Birds-of-a-Feather Round Table Discussion:  “When does audit trail begin?”

Birds-of-a-Feather Round Table Discussion: “When does audit trail begin?”

Audit trails create a step-by-step record of data back to its source. It is utilized when the integrity and confidence of the datapoint has critical/legal significance. It is important to determine and declare when data entry becomes “real” data. In legacy paper, data is manually recorded, but only becomes “real” when it is signed, submitted, or completed. Signatures and confirmations also exist to add additional credibility to the source. If a paper form is being filled, it is considered draft until it is declared complete by the originator. The originator has the option to crumple up the “draft” paper and start another without question. The same should hold true with electronic data entry as this webinar will discuss.

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