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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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Electronic Data Capture

Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting
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Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting

Applied Clinical Trial's article on eCFs eSource-Readiness Assessment (eSRA)

Applied Clinical Trials has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.

eCF Webinar: Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials
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eCF Webinar: Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials

10-January-2019 at UTC 1600

Facilitator:Hugo Cervantes, Vice President Vault CDMS, Veeva

Learn how top pharmaceutical companies and CROs plan to speed database build and data collection, as well as their top challenges and future priorities. This in-depth research from Tufts follows their industry-wide eClinical Landscape Study, examining the major cause of database build delays and their impact on trial cycle times.

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

11-October-2018 via webinar (one hour)

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

Date:  Wed, 25 July 2018     Duration: One hour

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.

ECF REPRESENTATIVES MEET WITH EMA GCP IWG
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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. We presented the work of the eClinical Forum in the areas of contractual requirements and risk-based software validation…  Expand article to read more...

Technology Showcase Webinar: "Developing Your eConsent Strategy - Best Practices "
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Technology Showcase Webinar: "Developing Your eConsent Strategy - Best Practices "

5 July 2017: Registration Required

Presented by:  Michael Tucker, Senior Product Solutions Specialist, Medidata Solutions

 

Open To: Staff from eClinical Forum member companies

Date : Wed, 5-July-2017         Duration: One hour

Time: UTC 1300:   (09:00 AM EDT, 15:00 CEST, 9:00 PM Singapore)  We apologize for the inconvenient time in some regions.

Click on title for more information

BoF: CDISC standards … what they are, where they are going, how they are being used … an overview from CDISC
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BoF: CDISC standards … what they are, where they are going, how they are being used … an overview from CDISC

5-April-2017; Registration Required

Facilitators: CDISC: Barrie Nelson, VP Standards and Terminology and Shannon Labout, VP Education


Time: UTC 1300;  15:00 CEST, 9:00 AM EDT, 9:00 PM Singapore. We apologize for the inconvenient timeslot in some regions.


Please click on title for more information.


Investigator Site Survey .. Please Participate
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Investigator Site Survey .. Please Participate

Partnering for Success

The ongoing Investigator Site Survey survey is open to all site staff involved in clinical trials. By participating in this survey, you will help us to better understand the experience and needs of site staff with clinical trial systems and processes. This is not eSRA -- it is a voluntary survey -- it is not an assessment.  (If you are looking for eSRA, please download the Handbook below).  GO TO THE SURVEY. Expand the article to read more...

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

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 

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