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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

2009: Revisiting the eClinical Paradigm - Investigational Site Perspectives on Clinical Trial Information Systems, DIA Nice Oct09

  • 16 May 2009
  • Author: Webmaster1
  • Number of views: 1154
  • 0 Comments
2009: Revisiting the eClinical Paradigm - Investigational Site Perspectives on Clinical Trial Information Systems, DIA Nice Oct09

As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions

2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009

  • 16 April 2009
  • Author: Webmaster1
  • Number of views: 1239
  • 0 Comments
2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009

2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009

2009: HL7 EHR Clinical Research Functional Profile, Release 1

  • 1 January 2009
  • Author: Webmaster1
  • Number of views: 1231
  • 0 Comments
2009: HL7 EHR Clinical Research Functional Profile, Release 1

2009: HL7 EHR Clinical Research Functional Profile, Release 1

2008: Considerations for Implementation of ePRO in Clinical Studies - V2

  • 1 December 2008
  • Author: Webmaster1
  • Number of views: 1409
  • 0 Comments
2008: Considerations for Implementation of ePRO in Clinical Studies - V2

Considerations for Implementation of Electronic Patient Reported Outcomes (ePRO) in Clinical Studies 

A Guide to the Options, Issues, Best Practices and Learning Experiences

2008, April: EMEA eSource Draft -- Comments from eClinical Forum

  • 1 April 2008
  • Author: Webmaster1
  • Number of views: 1377
  • 0 Comments
2008, April:  EMEA eSource Draft -- Comments from eClinical Forum

Please download to review these comments.

2007: Electronic Health Records for Clinical Research Project Description

  • 1 February 2007
  • Author: Webmaster1
  • Number of views: 1294
  • 0 Comments
2007: Electronic Health Records for Clinical Research Project Description

Please download to review this document.

2006, Sept: The Future Vision of Electronic Health Records as eSource for Clinical Research

  • 1 October 2006
  • Author: Webmaster1
  • Number of views: 1331
  • 0 Comments
2006, Sept: The Future Vision of Electronic Health Records as eSource for Clinical Research

Please download to review this position paper.

2005: US PhRMA's Electronic Clinical Data Capture Position Paper Revision 1

  • 1 May 2005
  • Author: Webmaster1
  • Number of views: 1345
  • 0 Comments
2005: US PhRMA's Electronic Clinical Data Capture Position Paper Revision 1

Please download to review this position paper.

2004: EDC Performance Metrics - Full Report

  • 22 June 2004
  • Author: Webmaster1
  • Number of views: 1626
  • 0 Comments
2004: EDC Performance Metrics - Full Report

The eClinical Forum's 2004 Metric Survey of companies involved in conducting EDC trials assesses the feasibility of establishing standard EDC performance metrics.

2003: eCF Presentation to EMEA GCP Inspectors on EDC

  • 22 October 2003
  • Author: Webmaster1
  • Number of views: 1540
  • 0 Comments
2003:  eCF Presentation to EMEA GCP Inspectors on EDC

Please download to review this presentation.

THE USE OF ELECTRONIC SOURCE DOCUMENTATION - V1.1 May 2003

  • 12 May 2003
  • Author: Webmaster1
  • Number of views: 2215
  • 0 Comments
THE USE OF ELECTRONIC SOURCE DOCUMENTATION - V1.1 May 2003

This 13-page position paper on eSource (source data that has been captured by an electronic tool which is a replacement for paper) describes the regulatory environment for the ultimate benefit of all stakeholders involved in EDC.

2003: Regulatory Environment for Electronic Data Capture

  • 12 February 2003
  • Author: Webmaster1
  • Number of views: 1487
  • 0 Comments
2003: Regulatory Environment for Electronic Data Capture

Please download to review this report.

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eCF Views & News

eCF Views & News

We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.

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eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping

eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.

The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.

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eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

eCF “Think GCP” Webinar:  ICH E6(R3) for eCF Members

Presenter:        Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic:  The final piece of the GCP renovation puzzle, revision 3 of ICH GCP.  Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.

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eCF Webinar:  Audit Trail Review – Is your Audit Trail fit for purpose?

eCF Webinar:  Audit Trail Review – Is your Audit Trail fit for purpose?

Date:                Thursday, February 20, 2025      Duration: One hour

Presenter:       Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM)

Dr Torsten Stemmler has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.

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