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  • 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
  • Tokyo 4-5 December 2017
    Tokyo 4-5 December 2017
  • Wellesely, MA 16-18 October 2017
    Wellesely, MA 16-18 October 2017
  • BERLIN 26-28 SEP 2017
    BERLIN 26-28 SEP 2017
  • REYKJAVIK 8-10 MAY 2017
    REYKJAVIK 8-10 MAY 2017
  • BLUE BELL, PA 24-26 OCT 2016
    BLUE BELL, PA 24-26 OCT 2016
  • BASEL 10-12 OCT 2016
    BASEL 10-12 OCT 2016
  • SINGAPORE 1-3 JUNE 2016
    SINGAPORE 1-3 JUNE 2016
  • UPPSALA 17-19 MAY 2016
    UPPSALA 17-19 MAY 2016
  • INDIANAPOLIS 25-27 APR 2016
    INDIANAPOLIS 25-27 APR 2016
  • NEW YORK 19-21 OCT 2015
    NEW YORK 19-21 OCT 2015
  • HORSHAM 5-7 OCT 2015
    HORSHAM 5-7 OCT 2015
  • SINGAPORE 3-4 SEP 2015
    SINGAPORE 3-4 SEP 2015
  • NORTH WALES, PA 18-20 MAY 2015
    NORTH WALES, PA 18-20 MAY 2015
  • SIENA 28-30 APR 2015
    SIENA 28-30 APR 2015
  • BANGALORE 5-6 FEB 2015
    BANGALORE 5-6 FEB 2015
  • CAMBRIDGE, MA 22-24 OCT 2014
    CAMBRIDGE, MA 22-24 OCT 2014
  • COPENHAGEN 16-18 SEP 2014
    COPENHAGEN 16-18 SEP 2014
  • SINGAPORE 20-21 MAY 2014
    SINGAPORE 20-21 MAY 2014
  • AMSTERDAM 14-16 MAY 2014
    AMSTERDAM 14-16 MAY 2014
  • BOULDER 30 APR - 2 MAY 2014
    BOULDER 30 APR - 2 MAY 2014
  • RESTON, VA 28-30 OCT 2013
    RESTON, VA 28-30 OCT 2013
  • DUBLIN 18-20 SEP 2013
    DUBLIN 18-20 SEP 2013
  • KASNSAS CITY 7-9 MAY 2013
    KASNSAS CITY 7-9 MAY 2013
  • EDINBURGH 22-24 APR 2013
    EDINBURGH 22-24 APR 2013
  • MONTVILLE, NJ 14-16 NOV 2012
    MONTVILLE, NJ 14-16 NOV 2012
  • MADRID 1-3 OCT 2012
    MADRID 1-3 OCT 2012
  • PARIS 21-23 MAY 2012
    PARIS 21-23 MAY 2012
  • EAST HANOVER, NJ 7-8 MAY 2012
    EAST HANOVER, NJ 7-8 MAY 2012
  • STRASBOURG 28-30 NOV 2011
    STRASBOURG 28-30 NOV 2011
  • NEWPORT BEACH 2-3 NOV 2011
    NEWPORT BEACH 2-3 NOV 2011
  • BANBURY 4-6 MAY 2011
    BANBURY 4-6 MAY 2011
  • CAMBRIDGE, MA 12-13 APRIL 2011
    CAMBRIDGE, MA 12-13 APRIL 2011
  • FORT LAUDERDALE 3-5 NOV 2010
    FORT LAUDERDALE 3-5 NOV 2010
  • BRUSSELS 6-8 OCT 2010
    BRUSSELS 6-8 OCT 2010
  • PARIS 5-7 MAY 2010
    PARIS 5-7 MAY 2010

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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We are working on updating eSRA right now!

Sponsors & CROs -- Please take a few minutes to complete this brief survey regarding how your company reviews site healthcare systems. We would like the input of every company whether you are using eSRA or your own assessment or not assessing at all.

https://www.surveymonkey.com/r/Site_System_Assessment_Survey

The link/survey will only be active until the end of May 2019, but we encourage you to complete the survey before Friday, February 22 2019, as we need the information to improve the eSRA Version 2019 which will be available the first week of March. Responses after Feb 22, 2019 will be considered for the 2020 version.

Sites -- If you would like to provide feedback for the eSRA V2019, please describe your feedback in an email to esra@eclinicalforum.org 

Thank you in advance for your help!

eClinical Forum eSRA Team (comprised of members from Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, OmniComm, Pfizer)

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2/28/2019 UTC
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Technology Showcase: eClinical Solutions -- Enabling D-Clinical - Digital Data Strategy and the elluminate Clinical Data Hub

This webinar will share 

  • Key drivers enabling digital transformation in Life Science
  • Importance of digital data strategy within life sciences 
  • How Clinical Data Hub technology platforms like elluminate support Digital Data Strategies 
  • Demonstration of the elluminate Clinical Data Hub capabilities including data ingestion, standards mapping, aggregation and analytics. 
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