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  • Virtual Workshop 12-16 October 2020
    Virtual Workshop 12-16 October 2020
  • Virtual Global Workshop 11-13 May 2020
    Virtual Global Workshop 11-13 May 2020
  • Tokyo 2-3 December 2019
    Tokyo 2-3 December 2019
  • Zurich 28-30 October 2019
    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

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

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BoF Round-table: Master Protocol Trial Designs & Data Management Considerations

Thursday, Oct 29, 2020

BoF Round-table: Master Protocol Trial Designs & Data Management Considerations

Facilitator:   Sara Hale, Amgen

Since the release of the FDA guidance for Adaptive Clinical Trial Design, many Sponsors have been working to enable Master Protocol trials. The MP designs includes 1. Basket Trial Design 2 Umbrella Trial Designs and Platform Trial Designs, which more complex in nature in that they are inclusive of multiple sub-studies within a single trial that within a traditional designs would have been separating out into separate trials. Making it necessary to consider fit-for-purpose strategic operational, process and system solutions.

BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

New Date: Oct 7 2020

BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity.   We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.  

Presenters:           Linda King, Astellas, eCF Audit Trail Review Team

                                Miko Pietilä, Signant Health, eCF Audit Trail Review Team

Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)

Recording of 8-July-2020 webinar available!

Birds-of-a-Feather Webinar: Real-world data (RWD) and real-world evidence (RWE)

According to the FDA’s website, “Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions.”  And a recent survey by the eClinical Forum showed that most respondents believe that RWD and RWE will become much more important in clinical research over the next few years.  As a result, many questions have arisen regarding the use cases, data sources, quality of these sources, regulatory guidance documents and so on. The goal of this “Birds of a Feather” session is to present some basic information on these topics and to present a few case examples to illustrate how RWD and RWE are playing an increasingly important role in research. 

Birds-of-a-Feather Round Table Discussion: U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

August 18, 2020

Birds-of-a-Feather Round Table Discussion:  U.S. National Patient Identifier (NPI) and its Impact to Clinical Trials

Presenter/Facilitator:  Ken Light, Clinscape

In 1996, HIPAA legislation called for the development of a national patient identifier system that would give each person in the United States a permanently assigned, unique number to be used across the entire spectrum of the national healthcare system.   That project was never funded by congress, but just last year (June, 2019) Congress voted to appropriate $99 billion dollars to an HHS bill that included creation of a National Patient Identifier.

Ken will review this topic, and oversee a group dialog around the benefits, challenges, and impact related to healthcare and clinical trials.   

Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics

Thursday 23 July 2020

Technology Showcase: eClinical Solutions -- Automating the Clinical Data Pipeline for Enhanced Data Review & Analytics

There has been a dramatic increase in clinical data types, sources and systems in recent years enabling new insights into patient experiences while also presenting challenges in consolidating, standardizing and analyzing these new data streams.  The tools for centralizing, integrating, mapping and analyzing data have not kept pace with research and are causing cycle time delays and require numerous manual processes.  This technology showcase will describe how new platforms like the elluminate Clinical Data Platform are automating the ingestion of data from numerous eClinical systems and sources, enabling faster data mapping and standardization, supporting risk based data review and advancing both clinical and operational analytics.  

Presented by Sheila Rocchio and Sam Parnell of eClinical Solutions.

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10/7/2020 UTC
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BoF Webinar: The Use of Audit Trail Review as a Key Tool in Ensuring Data Integrity

Join us for a discussion of the eCF/SCDM industry position paper on the use of audit trail review as a key tool in ensuring data integrity.   We will share our thoughts on the rationale, opportunities and challenges, along with practical implementation recommendations.  

Presenters:           Linda King, Astellas, eCF Audit Trail Review Team

                                Miko Pietilä, Signant Health, eCF Audit Trail Review Team

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10/12/2020 - 10/16/2020 UTC
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REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020

We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
13
10/12/2020 - 10/16/2020 UTC
103

REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020

We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
14
10/12/2020 - 10/16/2020 UTC
103

REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020

We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
15
10/12/2020 - 10/16/2020 UTC
103

REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020

We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
16
10/12/2020 - 10/16/2020 UTC
103

REGISTRATIONS CLOSED: eClinical Forum Virtual Workshop, 12-16 October 2020

We are pleased to announce the details of our next Virtual Global Workshop on 12-16 October 2020 (which replaces our planned Global Workshop in Dublin which is postponed until 2021). The virtual workshop will include a mix of global and regional events and is open to participants from any member company in any region.

Our last virtual workshop was a great success and this one will be even better. We have made sure that sessions are as convenient as possible for the different timezones across the world by limiting the duration of global sessions and offering more regional sessions. Learning from each other is what we do best and we will be introducing a number of ways to increase interactivity during the workshop (although nothing can replace the networking and comeraderie of an eCF face-to-face meeting!). REGISTER HERE

Read more
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10/29/2020 UTC
111

BoF Round-table: Master Protocol Trial Designs & Data Management Considerations

Facilitator:   Sara Hale, Amgen

Since the release of the FDA guidance for Adaptive Clinical Trial Design, many Sponsors have been working to enable Master Protocol trials. The MP designs includes 1. Basket Trial Design 2 Umbrella Trial Designs and Platform Trial Designs, which more complex in nature in that they are inclusive of multiple sub-studies within a single trial that within a traditional designs would have been separating out into separate trials. Making it necessary to consider fit-for-purpose strategic operational, process and system solutions.

Read more
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