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    Tokyo 5-6 November 2018
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  • Darmstadt, 15-17 May 2018
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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

Login to also view news for Members.

Webinar/Telecon

As the saying goes... "birds of a feather flock together"... so these BoF sessions will focus on a limited topic with no set agenda. Any member can participate that has an interest in the topic area. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.
eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar
  • 218
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eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar

V2018PR March 2019 -- Webinar dates: April 15, 23

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

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. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar
  • 218
  • Article rating: No rating

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar

V2018PR March 2019 -- Webinar dates: April 15, 23

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

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. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

BoF Round-Table Discussion Webinar: ePRO Data Changes
  • 144
  • Article rating: No rating

BoF Round-Table Discussion Webinar: ePRO Data Changes

April 16 at UTC 13:00

Facilitator: Tom Haag, Cardinal Solutions Consulting

The use of ePRO in clinical studies presents an interesting challenge when data recorded by patients and site staff needs to change from initial entry. To the uninitiated, it would be logical to assume that once data is entered, it is never changed. Or at the very least, the data is cumulatively recorded in 21 CRF Part 11-compliant audit trails. This interactive discussion will focus on the data integrity and custody controls required by regulators, for changes that occur more often that we might think.

click on title for more information

Birds-of-a-Feather Webinar:  Patient Engagement: Techniques, Tools and Technologies
  • 234
  • Article rating: No rating

Birds-of-a-Feather Webinar:  Patient Engagement: Techniques, Tools and Technologies

Wed, March 27 at UTC 1300 and UTC 1900 (28-March at 6am for Sydney AUS)

FacilitatorDavid Stein, D. Bartley Consulting

Opening StatementsJeff Lee, President, eCOA & Patient Engagement, CRF Bracket and Martin Collyer, “Patient Engagement” Consultant

Duration: one hour (offered at UTC 1300 and UTC 1900)   Note: Sydney AU will be at 6am local time on 28-March.

(click on title for more information)

Technology Showcase Webinar:  How can a modern CTMS help you to ensure successful trial execution
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Technology Showcase Webinar: How can a modern CTMS help you to ensure successful trial execution

August 14 2019 at UTC 0700 and UTC 1500

Succeeding with CTMS – how can a modern CTMS help you to ensure successful trial execution
Knowing how and when to use clinical trial management software/systems (CTMS) and how to integrate data from other eclinical systems can help ensure successful trial execution. This tech showcase will highlight what you can expect from a modern CTMS including successful integration ideas and techniques.

Presented by: Jan Klint Nielsen, BSI Business Systems Integration AG

Available to staff from eClinical Forum member companies only. For more information, please contact webmaster3@eclinicalforum.org 

Technology Showcase: eClinical Solutions -- Enabling D-Clinical - Digital Data Strategy and the elluminate Clinical Data Hub
  • 500
  • Article rating: No rating

Technology Showcase: eClinical Solutions -- Enabling D-Clinical - Digital Data Strategy and the elluminate Clinical Data Hub

28 February 2019

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. 
eCF Webinar: Tufts Research: Strategies from Data Management Leaders to Speed Clinical Trials
  • 1133
  • Article rating: No rating

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 Webinar: AI and Machine Learning: Applications and Opportunities for Clinical Research
  • 2281
  • Article rating: No rating

Birds-of-a-Feather Webinar: AI and Machine Learning: Applications and Opportunities for Clinical Research

Tuesday, 25 Sept 2018 at UTC 1300 for 1 hour

Facilitator:    Sheila Rocchio, eClinical Solutions

This webinar discussed “What is AI and Machine Learning”, applications in clinical research both now and in the future, and what skill sets are needed to move this forward. Thank you to Sheila Rocchio for presenting the topic so well. A recording of this webinar is available to eClinical Forum members. Please contact webmaster3@eclinicalforum.org to get access to the recording.

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«April 2019»
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

We are happy to announce an updated release of the eSRA (eSource Readiness Assessment) Handbook and Assessment Form. This 2019 version 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.

Click on the tab in the top-right of this website (www.eclinicalforum.org) "eSource Readiness Assessment (eSRA)".

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3/27/2019 UTC
75

Birds-of-a-Feather Webinar:  Patient Engagement: Techniques, Tools and Technologies

FacilitatorDavid Stein, D. Bartley Consulting

Opening StatementsJeff Lee, President, eCOA & Patient Engagement, CRF Bracket and Martin Collyer, “Patient Engagement” Consultant

Duration: one hour (offered at UTC 1300 and UTC 1900)   Note: Sydney AU will be at 6am local time on 28-March.

(click on title for more information)

Read more
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8
4/8/2019 - 4/10/2019 UTC
68

eCF North America Spring Meeting 2019

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org  to suggest topics or get registration information.

Read more
9
4/8/2019 - 4/10/2019 UTC
68

eCF North America Spring Meeting 2019

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org  to suggest topics or get registration information.

Read more
10
4/8/2019 - 4/10/2019 UTC
68

eCF North America Spring Meeting 2019

Save the Date!! Please join us for our Spring meeting. Agenda topics will be announced in Feb 2019. All suggestions welcome -- please email Suzanne Bishop at webmaster3@eclinicalforum.org  to suggest topics or get registration information.

Read more
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15
4/15/2019 UTC
79

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

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. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

Read more
16
4/16/2019 UTC
78

BoF Round-Table Discussion Webinar: ePRO Data Changes

Facilitator: Tom Haag, Cardinal Solutions Consulting

The use of ePRO in clinical studies presents an interesting challenge when data recorded by patients and site staff needs to change from initial entry. To the uninitiated, it would be logical to assume that once data is entered, it is never changed. Or at the very least, the data is cumulatively recorded in 21 CRF Part 11-compliant audit trails. This interactive discussion will focus on the data integrity and custody controls required by regulators, for changes that occur more often that we might think.

click on title for more information

Read more
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2223
4/23/2019 UTC
79

eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2018PR”. This is a project the eCF REG team has been working on for a long time and is excited to now be sharing.  

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. 

To download this file, click on the Downloads tab at the top of this website page.

For more information on the free public webinars, click the title of this article.

Read more
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