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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

eCF Releases Key Documents and Tools

Partnering for Success

  • 20 November 2015
  • Author: Webmaster1
  • Number of views: 15954
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eCF Releases Key Documents and Tools

The eCF is releasing 3 documents via the eCF website “Members” area (un/pw required).  Please feel free to download them and share with other members of your company.

Risk-Based Approaches - Best practices for ensuring clinical data quality

  • 10 September 2013
  • Author: Webmaster1
  • Number of views: 1524
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Risk-Based Approaches - Best practices for ensuring clinical data quality

Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials.

EHR4CR - A new technological platform enabling the re-use of data from electronic health records

  • 12 March 2013
  • Author: Webmaster1
  • Number of views: 1942
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EHR4CR - A new technological platform enabling the re-use of data from electronic health records

CASE STUDY EHR4CR - A new technological platform enabling the re-use of data from electronic health records.

Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

  • 23 April 2012
  • Author: Webmaster1
  • Number of views: 1143
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Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

Submission of comments to the FDA on their Draft Guidance on Standardized Study Data

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

  • 6 February 2012
  • Author: Webmaster1
  • Number of views: 1193
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eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

eCF Submission to EMA on their Reflection Paper on the Use of IRT (Interactive Voice/Web response Systems in Clinical Trials)

Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research

  • 8 June 2011
  • Author: Webmaster1
  • Number of views: 1371
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Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research

Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research

eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

  • 5 April 2011
  • Author: Webmaster1
  • Number of views: 1300
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eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

eCF comments on FDA Draft Guidance: Electronic Source Doc in Clinical Investigations

2010: EuroRec Electronic Health Records for Clinical Research, Functional Profile, Version 1.0, January 2010

  • 16 July 2010
  • Author: Webmaster1
  • Number of views: 1372
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2010: EuroRec Electronic Health Records for Clinical Research, Functional Profile, Version 1.0, January 2010

The EHRCR Functional Profile Working Group is comprised of dedicated individuals from the United States and the European Union in the following industries: pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulator.

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

  • 16 May 2009
  • Author: Webmaster1
  • Number of views: 1263
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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: 1325
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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: 1310
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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: 1526
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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

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Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

Japanese Translation: eSRA Handbook and Assessment Forms V2025.2

の日本語版2025.2JP1が2025年6月30日にリリースされました。

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eCF "BoF" Round table: "A Chat about eCOA"

eCF "BoF" Round table: "A Chat about eCOA"

eClinical Forum Birds-of-a-Feather round-table webinars 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. 

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