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    Virtual Global Workshop 11-13 May 2020
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    Zurich 28-30 October 2019
  • Peapack 14-16 October 2019
    Peapack 14-16 October 2019
  • Brussels 15-17 May 2019
    Brussels 15-17 May 2019
  • Danbury 8-10 April 2019
    Danbury 8-10 April 2019

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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.


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

V2019PR March 2020

The eClinical Forum is happy to announce the Public release of the “eCF Requirements V2019PR”.

ABOUT THE ECF REQUIREMENTSThe 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, 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 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.

eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019
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eClinical Forum releases eSource-Readiness Assessment (eSRA) V2019

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

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)".

Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only
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Release: Requirements for Electronic Data for Regulated Clinical Trials "eCF Requirements" V2019 Members Only

eCF Members Release 25-March-2019

The eClinical Forum is happy to announce the V2019 Members-Only release of the “eCF Requirements”. 

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. The V2019 Members Release has 21 documents mapped.

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Birds-of-a-Feather Webinar: Tufts-eClinical Solutions "Data Strategy and Transformation Study Results"

eClinical Solutions, a member of the eClinical Forum, has collaborated with the Tufts Center for the Study of Drug Development in 2019 to survey pharmaceutical companies about their evolving clinical data demands and the tactics they are employing to manage and leverage their data. Highlights reveal new strategies and digital transformation initiatives being taken. This webinar will share key results from the survey as well as insights and opportunities to use this data to further clinical data architectures. 

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5/11/2020 - 5/13/2020 UTC
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REGISTRATION OPEN: eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

Getting our members together to talk out the current issues and do creative problem-solving is what we do best. Sadly, due to the Covid-19 Pandemic, the following meetings are cancelled:

April 27-29 2020:  Helsinki Finland, hosted by Signant Health

May 11-13 2020:  New Jersey, USA hosted by Diligent Pharma

But that doesn't mean we won't be "getting together"! We are announcing our "Virtual Global Workshop" for 11-13 May 2020.

Expand the article for the workshop agenda and registration details.

Read more
12
5/11/2020 - 5/13/2020 UTC
91

REGISTRATION OPEN: eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

Getting our members together to talk out the current issues and do creative problem-solving is what we do best. Sadly, due to the Covid-19 Pandemic, the following meetings are cancelled:

April 27-29 2020:  Helsinki Finland, hosted by Signant Health

May 11-13 2020:  New Jersey, USA hosted by Diligent Pharma

But that doesn't mean we won't be "getting together"! We are announcing our "Virtual Global Workshop" for 11-13 May 2020.

Expand the article for the workshop agenda and registration details.

Read more
13
5/11/2020 - 5/13/2020 UTC
91

REGISTRATION OPEN: eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

Getting our members together to talk out the current issues and do creative problem-solving is what we do best. Sadly, due to the Covid-19 Pandemic, the following meetings are cancelled:

April 27-29 2020:  Helsinki Finland, hosted by Signant Health

May 11-13 2020:  New Jersey, USA hosted by Diligent Pharma

But that doesn't mean we won't be "getting together"! We are announcing our "Virtual Global Workshop" for 11-13 May 2020.

Expand the article for the workshop agenda and registration details.

Read more
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