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

eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Sept 25, 2019 presented by Jill Platko and Miko Pietila of Signant Health

  • 25/09/2019
  • Author: Webmaster1
  • Number of views: 2183
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eCF Birds-of-a-Feather Webinar: Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More

Electronic solutions for patient-reported and clinician-reported outcomes provide rich metadata that can be mined for additional insights describing trial performance and driving risk-based monitoring. We will explore the use of this eCOA meta data in fraud detection, and other analytics insights and how these data might translate to risk indices to inform risk-based monitoring activities.

eCF European Autumn Meeting in Zurich Switzerland to be hosted by BSI

28-30 October 2019

  • 28/10/2019 - 30/10/2019
  • Author: Webmaster1
  • Number of views: 3647
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eCF European Autumn Meeting in Zurich Switzerland to be hosted by BSI

Networking with peers has never been more important in order to stay current, collaborate on shared challenges and influence the future. The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives.

This meeting will be of relevance to those with an interest in advancing clinical research from:

  • Clinical Trial sponsor organisations
  • Healthcare institutions
  • Technology providers
  • Service providers
  • Academia
  • Stakeholder groups and associations
  • Government

Asia Pacific Meeting in Tokyo to be hosted by Eli Lilly

2-3 December 2019

  • 02/12/2019 - 03/12/2019
  • Author: Webmaster1
  • Number of views: 3313
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Asia Pacific Meeting in Tokyo to be hosted by Eli Lilly

The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives and to influence the future. The following areas will be discussed.

  • The evolving landscape of the Pharma/Clinical Research industry
  • Clinical Trial Operations
  • Regulatory / Compliance
  • Emerging Technologies/Processes
  • Trial of the Future
  • eCF Project Teams: Progressing shared initiatives

North America Autumn Meeting to be hosted by Pfizer in Peapack NJ

Oct 14-16 2019

North America Autumn Meeting to be hosted by Pfizer in Peapack NJ

The eClinical Forum offers a unique, non-commercial networking environment to learn, exchange information and ideas, collaborate on shared initiatives and to influence the future.  A comment from our Spring 2019 meeting: “Great Forum again! Relevant topics and participants are SMEs or at least willing to share experiences.” 

The meeting starts at 1pm on Mon Oct 14 2019 and finishes at 3pm on Wed Oct 16 2019. Each evening there will be networking social events included as part of your meeting registration.

eCF Technology Showcase: A Centralized approach to the RFI and Vendor Qualification processes

Diligent Qualification Platform Solution Overview -- July 18 2019

eCF Technology Showcase: A Centralized approach to the RFI and Vendor Qualification processes

This webinar will be a comprehensive, deep dive into the overall RFI and Vendor Qualification solution offered by the Diligent Qualification Platform.

Attendees will be informed of the true costs of the RFI and Qualification effort from both sides of the table, the sponsor and the provider.  Attendees will also be taken through the improved, simplified and more efficient process available with the centralized solution offered by Diligent via a short platform demonstration.

eClinical Forum does not endorse any vendor solution but rather offers technology showcases to our Technology Vendors as a way for all eCF members to get to know each other. Contact webmaster3@eclinicalforum.org for registration information.

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

August 14 2019 at UTC 0700 and UTC 1500

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

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 

eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Better Together

  • 15/05/2019 - 18/05/2019
  • Author: Webmaster1
  • Number of views: 3976
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eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019

Our European meeting of the eClinical Forum took place in Brussels 15-17 May 2019, kindly hosted by Janssen.  The rousing meeting was well attended by members from Actelion, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CRF Bracket, CSL Behring, Eli Lilly, eResearch Technology, Glaxo SmithKline, Idorsia, Janssen Pharmaceuticals, Medidata, Merck KGaA, Munich Technical University, Neptunus Data, Novartis, Novo Nordisk, Oracle, Orion, Servier, Wega Informatik, ZeinCRO ... and guests Association for Innovative Medicines, ECRIN, and European Patients' Forum.  Meeting participants rated this meeting highly successful once again!

eCF North America Spring Meeting 2019

April 8-10 2019 hosted by Boehringer Ingelheim in Ridgefield CT

  • 08/04/2019 - 11/04/2019
  • Author: Webmaster1
  • Number of views: 4642
  • 0 Comments
eCF North America Spring Meeting 2019

The North American Spring Meeting was held at Boehringer-Ingelheim in Ridgefield CT on April 8-10 2019.   Attendees were from Actigraph, Allergan, Astellas, Bioverativ, Boehringer-Ingelheim, Bristol-Myers Squibb, BSI Business Systems Integration, Cardinal Solutions, Cenduit, CRF Bracket, CSL Behring, Diligent Pharma, eClinical Solutions, Eli Lilly, ERT, Health Quest, ICON, Merck & Co., Neptunus Data, Novartis, Pfizer, Target Health, Veeva and West Connecticut Health Network. The meeting was rated by the attendees as 4.8/5.0 with comments "Great Forum again! Relevant topics and participants are SMEs or at least willing to share experiences.", "You get better every year! This was a STELLAR meeting -- Great faciliticies, events and attendees/presenters!", "Excellent meeting. It was my first eCF meeting but I hope to attend many more. Great group. I learned a great deal.", :Awesome meeting!"  Slides and meeting output are available to members -- please contact webmaster3@eclinicalforum.org. 

See you at our next meeting hosted by Pfizer in Peapack, NJ on Oct 14-16 2019!

BoF Round-Table Discussion Webinar: ePRO Data Changes

April 16 at UTC 13:00

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

Announcing Autumn 2019 Meeting Dates

  • 14/10/2019 - 17/10/2019
  • Author: Webmaster1
  • Number of views: 4995
  • 0 Comments
Announcing Autumn 2019 Meeting Dates

Save the date!!

Oct 14-16 2019 in Peapack, New Jersey USA. Kindly hosted by Pfizer

Oct 28-30 2019 in Zurich, Switzerland EU. Kindly hosted by Business Systems Integration (BSI)

Dec 2-3 2019 in Tokyo, Japan. Kindly hosted by Eli Lilly

Announcing Autumn 2019 Meeting Dates

  • 28/10/2019 - 31/10/2019
  • Author: Webmaster1
  • Number of views: 4995
  • 0 Comments
Announcing Autumn 2019 Meeting Dates

Save the date!!

Oct 14-16 2019 in Peapack, New Jersey USA. Kindly hosted by Pfizer

Oct 28-30 2019 in Zurich, Switzerland EU. Kindly hosted by Business Systems Integration (BSI)

Dec 2-3 2019 in Tokyo, Japan. Kindly hosted by Eli Lilly

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)

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)

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«November 2021»
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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

Read more
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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

Read more
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AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

AGENDA AVAILABLE: eClinical Forum Virtual Workshop, 19-28 October 2021

We are pleased to announce the details of our next Virtual Global Workshop on 19-28 October 2021. The virtual workshop will include presentation, discussion and working sessions and is open to participants from any member company in any region.

Our virtual workshops have been a great success and this one will be even better! The sessions have been optimised to accommodate our members from around the world by spreading the meeting over 6 days (19-21 October and 26-28 October), limiting the duration of each meeting day to 2 hours and by offering 2 sessions a day (at 8:00 UTC and 16:00 UTC). Learning from each other is what we do best, and the workshop will provide opportunity for collaboration and exchange through breakout groups to contribute to the work of the eClinical Forum, round table discussions on hot topics and time for Q&A.  Of course, nothing can replace the networking and camaraderie of a face-to-face eCF meeting, but we will come close! REGISTER HERE

Read more
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eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

eCF Webinar: Connecting Clinical Research and Healthcare: The Vulcan HL7 Accelerator Opportunity

HL7 FHIR (Fast Healthcare Interoperability Resources) is a standard describing data formats and elements and an application programming interface for exchanging electronic health records. The standard was created by the Health Level Seven International health-care standards organization.  Vulcan is an HL7 FHIR Accelerator that brings together stakeholders from across the translational and clinical research communities in order to bridge existing gaps between clinical care and clinical research, strategically connect industry collaboratives, maximize collective resources, and deliver integrated tools and resources.  HL7 FHIR is the path forward to bridge clinical care and clinical research. A global collaboration between all translational and clinical research stakeholders to co-develop out the standard, it will allow for a reproducible, scalable process for data exchange. The presenters will share not only the conclusions drawn from use cases developed up to this point, but will also provide insight into the future direction and priorities of Vulcan.  

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Upcoming events Events RSSiCalendar export

  • eCF Webinar:  Best Practice Recommendations for Changing eCOA Data (07/12/2021 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
    eCF Webinar:  Best Practice Recommendations for Changing eCOA Data

    eCF Webinar:  Best Practice Recommendations for Changing eCOA Data

    Historically, each sponsor, contract research organization (CRO), clinical site, and eCOA service provider has handled eCOA data change request (DCR) processes differently, resulting in the possibility for mixed expectations among the stakeholders and inconsistent results.   In the worst-case scenario, there is the risk of findings from inspections and audits, either because control over source records did not reside as expected with the site, or because there was a lack of oversight over eCOA data changes requested by sites and performed by the eCOA service provider.  There is a need for a well-defined, consistent, and balanced process for handling eCOA data change requests in clinical trials.  The objective of this document is to outline best practices that will result in improved data accuracy and integrity, greater transparency amongst the different stakeholders, increased consistency throughout the clinical trials industry, and adherence to the study protocol, good clinical practices (GCP), and government regulations. The approach to eCOA data changes outlined here is focused on patient-reported outcome (PRO) data but can be applied, where appropriate, to all eCOA data, including clinician-reported data and observer-reported data.   

    A collaborative team comprised of Critical Path Institute’s ePRO Consortium, PRO Consortium and eClinical Forum have been meeting since early 2020 to discuss this topic and produce a best-practice recommendations paper. They will be sharing their discussions during this webinar. The associated paper is anticipated to be published during 1Q 2022.

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  • eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials. (11/01/2022 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
    eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

    eCF Webinar: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials.

    We will be discussing a recent eCF/EUCROF positions paper: 

    The full history of a clinical trial describes the conduct of the trial and the quality of the data produced. Changes in technology and the evolution of regulatory expectations on electronic systems over the past two decades have resulted in a situation where additional supplementary documentation is needed to reconstruct some clinical trial activities. Many of the computerised systems used during a trial are only used during the active trial data collection stage. This period of use is shorter than the retention period required for the archiving of the essential documents of the trial. Furthermore, the documentation that makes up this history is distributed between sponsor, investigators and vendors. Data is stored locally, in the cloud, on patient devices, at vendors, and sub-vendors. Where the data is archived (sponsor, investigator, vendor), in what format (kept live or static), and for how long are issues discussed in the position paper.  You can download the position paper here: Position Paper: Trial Master File Archiving and the Decommissioning of Computerised Systems Used in Clinical Trials, PR1 (eclinicalforum.org)

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