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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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(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
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)".
Birds-of-a-Feather Webinar: Patient Engagement: Techniques, Tools and Technologies
Facilitator: David Stein, D. Bartley Consulting
Opening Statements: Jeff 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)
eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials"
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.
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 firstname.lastname@example.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
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
BoF Webinar: EHR to EDC for Automated Population of CRF
Where is your organization on the EHR to EDC journey? Not started, early prototypes, other?
What is the principal value your organization expects from EHR to EDC one day?
Come join us as we cover a perspective of some of the work happening across the industry to take advantage of this valuable Data Source.
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 email@example.com for registration information.
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 firstname.lastname@example.org
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
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 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:
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.