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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.

 

NEWS FROM THE ECF

Technology Showcase: Challenges to the Adoption of Paperless Trials During the COVID-19 Epidemic and Beyond

December 1 at UTC 1500 and recording

Technology Showcase: Challenges to the Adoption of Paperless Trials During the COVID-19 Epidemic and Beyond

Presenter:  Dr. Jules Mitchel, Target Health

About this Topic:  Clearly, the implementation of traditional clinical research studies as well as executing COVID-19 studies themselves. have been dramatically impacted by global COVID-19 pandemic.  Since showing up at clinical sites in general is becoming less feasible, clinical research must adapt. While there are many exciting ideas to execute virtual and remote studies, the focus still needs to be on the assurances that 1. the clinical sites understand and are following the protocol; 2. the data can and are being entered and reviewed in “real time,” 3. there are the “absence of errors that matter” and 4. the “data are fit for purpose.”  This session will showcase several studies using the Target Health web-based application, with Informed Consent fully integrated with real time direct data capture, real time reports, online monitoring reports and safety reporting.

BoF Webinar: IMI Mobilise-D -- Measuring and validating real-world mobility – Easier said than done

Tues, 10 Nov 2020

BoF Webinar: IMI Mobilise-D -- Measuring and validating real-world mobility – Easier said than done

Date:  Tuesday 10-November, 2020  Duration: One hour  Time: UTC 1500

Presenter:   Beatrix Vereijken (Norwegian University of Science and Technology) and Valdo Arnera (ERT Technology)

Mobility is an important marker of health, key to our independence, and a major driver for quality of life. Many aspects of how we walk can be easily measured and quantified in a well-equipped scientific or clinical laboratory, but this ‘artificial snapshot in time’ is a poor indicator of how well we move about in the real world. Recent advances in digital technologies have opened the door to monitoring mobility 24/7 but going beyond the number of steps or the vigour of moving has shown remarkably difficult. Yet, accurate assessment of daily life mobility in clinical trials and patient treatment is necessary for improved and more personalised care, but what is required to get there?

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

Better Together

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

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

Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

Offered on September 9 2020

  • 09/09/2020 - 10/09/2020
  • Author: Webmaster1
  • Number of views: 1419
  • 0 Comments
Free Public Webinar: Assessment of Investigator Site Systems that may originate source for clinical trials & the free eSRA tool (Japanese)

eSRA (eSource Readiness Assessment) is a tool to assess the data that has originated in an Investigator Site system (Electronic Health Records (EHR) or Electronic Medical Records (EMR) according to different health authorities. eClinical Forum issued a Japanese translation of eSRA Handbook in July.  This seminar is targeted for Japanese audiences, and eSRA will be explained in Japanese.
eSRA (eSource Readiness Assessment)はEHR/EMRなどの医療機関のシステムのデータを治験に利用できるかどうか評価するためのツールであり、7月にeSRA Handbookの日本語版がリリースされました。本Webinarは日本の方を対象にeSRAをご紹介するものです。ぜひご参加をお待ちしています。

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.

Success! eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

  • 11/05/2020 - 14/05/2020
  • Author: Webmaster1
  • Number of views: 4796
  • 0 Comments
Success! eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020

The Virtual Workshop on May 11-13 that replaced the planned face-to-face Spring Workshops in Helsinki, Finland and Princeton, NJ was a huge success.  It was attended by over 130 members from around the globe, representing 46 member companies -- many of whom would not have been able to attend a face-to-face meeting and this was their first eCF workshop. 4 EMA inspectors and several guests also attended. Evaluations gave the workshop a 4.3/5.0 which is lower than our face-to-face workshops, but for our first virtual workshop we are happy with this grade!  A few comments from the evaluations: "Always an excellent group with many real experts.  The interactions are very good."  "Congratulations on an excellent event.  Everything worked well.  Sure, we missed the networking and evening events, but this worked well."  "eClinical Forum is a fantastic source of information about the landscape of eClinical today."  "eCF continues to be incredible value for money"

We are planning for another Virtual Workshop in Autumn 2020 (the week of October 12-16) and hoping to return to face-to-face workshops for Spring 2021. We now have a lot of good ideas for improvements for our 2nd Virtual Workshop! If anyone wants to make suggestions, please send to info@eclinicalforum.org. Thanks!!

Bird-of-a-Feather Webinar: Agile Development for Clinical Research Software

Wednesday, June 17, 2020

Bird-of-a-Feather Webinar: Agile Development for Clinical Research Software

Agile computing methods and tools are used in almost all software development today. Alan Yeomans, Quality Manager at Viedoc Technologies AB, will address some of the key issues involved when using agile methods and tools for the development of clinical research software. The theory behind how agile software development can be used for clinical research software will be followed with an example of a working development methodology incorporating agile methods and tools – how does a real software development organisation implement these methods and tools while maintaining regulatory compliance?

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

Thursday April 30 2020

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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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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