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  • Tokyo 3-4 December 2019
    Tokyo 3-4 December 2019
  • Zurich 28-30 October 2019
    Zurich 28-30 October 2019
  • Peapack 14-16 October 2019
    Peapack 14-16 October 2019
  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
  • Danbury 8-10 April 2019
    Danbury 8-10 April 2019
  • Tokyo 5-6 November 2018
    Tokyo 5-6 November 2018
  • Paris, France 23-25 October 2018
    Paris, France 23-25 October 2018
  • Philadelphia, USA 2-4 October 2018
    Philadelphia, USA 2-4 October 2018
  • Princeton 1-3 May 2018
    Princeton 1-3 May 2018
  • Darmstadt, 15-17 May 2018
    Darmstadt, 15-17 May 2018

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

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eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More
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eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Sept 25, 2019 presented by Jill Platko and Miko Pietila of Signant Health

Electronic solutions for patient-reported and clinician-reported outcomes provide rich metadata that can be mined for additional insights describing trial performance and driving risk-based monitoring. We will explore the use of this eCOA meta data in fraud detection, and other analytics insights and how these data might translate to risk indices to inform risk-based monitoring activities.

Applied Clinical Trials publishes article on eCF Requirements
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Applied Clinical Trials publishes article on eCF Requirements

Applied Clinical Trials has published an article highlighting the eClinical Forum “Requirements for Electronic Data for Regulated Clinical Trials” (or simply, “eCF Requirements”: http://www.appliedclinicaltrialsonline.com/keeping-regulatory-expectations .  July 8, 2019

The eCF Requirements are based upon statements in regulatory documents (from the FDA, EMA, PMDA and ICH) that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial

North America Autumn Meeting to be hosted by Pfizer in Peapack NJ
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North America Autumn Meeting to be hosted by Pfizer in Peapack NJ

Oct 14-16 2019

The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives and to influence the future.  A comment from our Spring 2019 meeting: “Great Forum again! Relevant topics and participants are SMEs or at least willing to share experiences.” 

The meeting starts at 1pm on Mon Oct 14 2019 and finishes at 3pm on Wed Oct 16 2019. Each evening there will be networking social events included as part of your meeting registration.

eCF Technology Showcase: A Centralized approach to the RFI and Vendor Qualification processes
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eCF Technology Showcase: A Centralized approach to the RFI and Vendor Qualification processes

Diligent Qualification Platform Solution Overview -- July 18 2019

This webinar will be a comprehensive, deep dive into the overall RFI and Vendor Qualification solution offered by the Diligent Qualification Platform.

Attendees will be informed of the true costs of the RFI and Qualification effort from both sides of the table, the sponsor and the provider.  Attendees will also be taken through the improved, simplified and more efficient process available with the centralized solution offered by Diligent via a short platform demonstration.

eClinical Forum does not endorse any vendor solution but rather offers technology showcases to our Technology Vendors as a way for all eCF members to get to know each other. Contact webmaster3@eclinicalforum.org for registration information.

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"
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eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"

V2018PR March 2019

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

Technology Showcase Webinar:  How can a modern CTMS help you to ensure successful trial execution
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Technology Showcase Webinar: How can a modern CTMS help you to ensure successful trial execution

August 14 2019 at UTC 0700 and UTC 1500

Succeeding with CTMS – how can a modern CTMS help you to ensure successful trial execution
Knowing how and when to use clinical trial management software/systems (CTMS) and how to integrate data from other eclinical systems can help ensure successful trial execution. This tech showcase will highlight what you can expect from a modern CTMS including successful integration ideas and techniques.

Presented by: Jan Klint Nielsen, BSI Business Systems Integration AG

Available to staff from eClinical Forum member companies only. For more information, please contact webmaster3@eclinicalforum.org 

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

Investigator Site self-assessment of their healthcare systems against clinical research regulations and guidance

We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version is an update, based on updates to FDA, EMA, PMDA and ICH regulatory documents. We encourage all Sponsors to use this assessment to assist in determining if data that originated in an investigator site system is suitable for inclusion in a clinical trial. We encourage all Investigator Sites to use this assessment tool and provide the resulting report to all Sponsors they are working with, thus avoiding the need to complete different assessments for each Sponsor. Full details of what this valuable tool provides can be found in the eSRA Handbook.

Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".

eCF North America Spring Meeting 2019
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eCF North America Spring Meeting 2019

April 8-10 2019 hosted by Boehringer Ingelheim in Ridgefield CT

The North American Spring Meeting was held at Boehringer-Ingelheim in Ridgefield CT on April 8-10 2019.   Attendees were from Actigraph, Allergan, Astellas, Bioverativ, Boehringer-Ingelheim, Bristol-Myers Squibb, BSI Business Systems Integration, Cardinal Solutions, Cenduit, CRF Bracket, CSL Behring, Diligent Pharma, eClinical Solutions, Eli Lilly, ERT, Health Quest, ICON, Merck & Co., Neptunus Data, Novartis, Pfizer, Target Health, Veeva and West Connecticut Health Network. The meeting was rated by the attendees as 4.8/5.0 with comments "Great Forum again! Relevant topics and participants are SMEs or at least willing to share experiences.", "You get better every year! This was a STELLAR meeting -- Great faciliticies, events and attendees/presenters!", "Excellent meeting. It was my first eCF meeting but I hope to attend many more. Great group. I learned a great deal.", :Awesome meeting!"  Slides and meeting output are available to members -- please contact webmaster3@eclinicalforum.org. 

See you at our next meeting hosted by Pfizer in Peapack, NJ on Oct 14-16 2019!

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eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Electronic solutions for patient-reported and clinician-reported outcomes provide rich metadata that can be mined for additional insights describing trial performance and driving risk-based monitoring. We will explore the use of this eCOA meta data in fraud detection, and other analytics insights and how these data might translate to risk indices to inform risk-based monitoring activities.

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