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  • Tokyo 5-6 November 2018
    Tokyo 5-6 November 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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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

15-August-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.

Birds-of-a-Feather Discussion:  ICH-E6 (R2) and Industry Adoption of RBM
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Birds-of-a-Feather Discussion:  ICH-E6 (R2) and Industry Adoption of RBM

19-June-2018 via webinar (one hour)

Presenters:  Abby Abraham and Ken Light, OmniComm Systems

Open To: Staff from eClinical Forum member companies  (If you are not an eCF member, please review our website www.eclinicalforum.org for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum Birds-of-a-Feather sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements"
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Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements"

eCF Members Release 27-April-2018

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

The eCF Requirements 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.  We have reviewed regulatory documents from the FDA, EMA, PMDA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if data which will become part of a regulated clinical trial are consistent with regulatory requirements.

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Outcome: North America Spring Meeting May 1-3 2018
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Outcome: North America Spring Meeting May 1-3 2018

Hosted by Bristol Myers Squibb in Princeton NJ

Our Spring North American meeting was held at Bristol-Myers Squibb in Princeton, New Jersey on 1-3 May 2018. Companies participating were Allergan, Allscripts, Array Bio-Pharma, Astellas, Bioverativ a Sanofi Company, Bristol-Myers Squibb, BSI Business Systems Integration AG, Cenduit, Cerner, CRF Health, CSL Behring, D. Bartley Consulting, eClinical Solutions, Elligo Health Research, Janssen Pharmaceuticals, Medidata, Novartis, Omnicomm, Oracle, Pfizer, Rutgers the State University of NJ, Target Health, Veeva. 

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2018.1
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2018.1

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

We are proud to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. It is provided free on this website via the "eSRA" tab. This Version 2018.1 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.

BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations
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BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations

Offered twice: Wed March 14 2018 for one hour at UCT 0800 and UTC 1700

What are the considerations and challenges to grant such access in the Sponsor’s systems... Facilitated by Cinzia Piccini, Eli Lilly & Co.

This BoF Discussion is open to all from eCF Member companies. Please contact suzanne.bishop@eclinicalforum.org to register for this BoF or for information on eCF membership.

BoF Discussion: Archiving – who is responsible and how should we support them?
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BoF Discussion: Archiving – who is responsible and how should we support them?

Wed Feb 21 2018 for one hour

This webinar looks to set up a discussion of possible archiving alternatives and how practical they are.  Facilitated by Alan Yeomans, Pharmaceutical Consulting Group.  Participants are encouraged to share their ideas and experiences!!

This webinar is for eCF Members only. Please contact suzanne.bishop@eclinicalforum.org for additional information on registration to this event or membership.

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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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