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

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event

Event Feedback

Webinar on ICH E6 Release2 (GCP) 11Jan17 - An Excellent Event
We had a fabulous level of participation with well over 140 members online from California to Japan participating in our first webinar of 2017 on the release of the addendum to E6 (Good Clinical Practice), 20 years after its original publication. Some good discussion helped us to understand the changes, opportunities and challenges. Expand the article to read more about the event.

White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

  • 22 December 2016
  • Author: Webmaster1
  • Number of views: 1476
  • 0 Comments
White Paper, Checklist and Task Ownership Matrix for Electronic Data Capture Systems in Clinical Trials using Service Providers

The eCF EDC Hosting Team has released the final White Paper documenting best practices for establishing controls and operational procedures that facilitate compliance with evolving regulatory expectations for Electronic Data Capture in Clinical Trials using Service Providers (e.g. EMA Reflection Paper and ICH GCP Addendum). The eCF has engaged with regulators (including the EMA GCP IWG and FDA) and industry stakeholders in developing the documents.

Electronic Informed Consent Technology Showcase - An Excellent Event

Event Feedback

  • 30 November 2016
  • Author: Webmaster
  • Number of views: 14832
  • 0 Comments
Electronic Informed Consent Technology Showcase - An Excellent Event

We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.

PI Signatures - ENDED

Evaluating regulations and guidances pertaining to principal investigator signatures on study data and materials

  • 2 November 2016
  • Author: Webmaster1
  • Number of views: 2446
  • 0 Comments
PI Signatures - ENDED

Evaluating regulations and guidances pertaining to principal investigator signatures on study data and materials

Free access to GCDMP

Re-Post from eCF LinkedIn

  • 26 October 2016
  • Author: Michel Arnoult
  • Number of views: 17899
  • 0 Comments
Free access to GCDMP
Anyone can now access to this important document for Data Management and Clinical Research.

Was Basel Our Best European Meeting Yet ?

A Network Powered by Peers

  • 19 October 2016
  • Author: Webmaster
  • Number of views: 12180
  • 0 Comments
Was Basel Our Best European Meeting Yet ?

The eClinical Forum is a "Network Powered by Peers" and our workshops offer a unique balance of detail and vision, learning and cooperation, ideas creation and innovation. Meetings have always achieved near perfect ratings from members and the workshop in Basel 10-12 October 2016 was no exception. Our largest European meeting yet and one of the highest scoring! Expand the article to see member feedback and the topics discussed.

Adoption of Cloud Technology in the Regulated Life Sciences Industry

An eCF BoF Webinar presented by PhUSE

  • 27 September 2016
  • Author: Webmaster
  • Number of views: 12830
  • 0 Comments
Adoption of Cloud Technology in the Regulated Life Sciences Industry
PhUSE kindly presented their framework for the adoption of cloud technology in the regulated life sciences industry. The session was attended by 70 members from 24 companies in 14 countries. Expand the article to read more about the topic and discussion

Is your electronic health record system suitable for originating records that will be used in regulated clinical trials?

  • 2 March 2016
  • Author: Webmaster1
  • Number of views: 1992
  • 0 Comments
Is your electronic health record system suitable for originating records that will be used in regulated clinical trials?

Nearly 200 attendees participated in a webinar delivered by the eClinical Forum for ACRP.

The objective of the webinar was to allow attendees to:

  • Recognize the need to assess their electronic healthcare system to determine its appropriateness for originating and/or housing data that could be used in a regulated clinical research trial
  • Access a free tool to assist in assessing electronic health record systems

ACT Article on eCF Risk Based Monitoring Approaches and Best Practices

  • 15 December 2015
  • Author: Webmaster1
  • Number of views: 1955
  • 0 Comments
ACT Article on eCF Risk Based Monitoring Approaches and Best Practices

The eClinical Forum Risk Based Monitoring Taskforce offers some best practices for ensuring clinical data quality. Applied Clinical Trials July/August 2013

Site Survey Presentation - DIA Clinical Forum Lisbon 13 Oct10

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 1959
  • 0 Comments
Site Survey Presentation - DIA Clinical Forum Lisbon 13 Oct10

Revisiting the eClinical Paradigm

Investigational Site Perspectives on Clinical Trial Information Systems

 

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.

2010: Practical Considerations for Clinical Trial Sites using EHRs In support of Clinical Research, Release 1.0 January 18, 2010

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 1254
  • 0 Comments
2010: Practical Considerations for Clinical Trial Sites using EHRs In support of Clinical Research, Release 1.0 January 18, 2010

2010: Practical Considerations for Clinical Trial Sites using EHRs In support of Clinical Research, Release 1.0 January 18, 2010

2001 to 2009: Investigational Site Perspectives on Clinical Trial Information Systems - Sep 2012

  • 3 December 2015
  • Author: Webmaster1
  • Number of views: 1240
  • 0 Comments
2001 to 2009: Investigational Site Perspectives on Clinical Trial Information Systems - Sep 2012

Abstract

In 2001, a survey was conducted by the eClinical Forum to explore the experience, needs, views and issues of investigational site staff with respect to Electronic Data Capture (EDC).

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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 Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry.  This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned.   Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials. 

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eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"

ABOUT THE ECF REQUIREMENTS:  The eClinical Forum has produced a set of Requirements, which 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, NMPA, MHRA 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 systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.

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