"This is the best use of my time to remain current with what is going on in the industry."
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.
Login to also view news for Members.
This webinar will share
Not a member?
Visit the Membership page to learn
How To Become a Member
(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)
Determining if Data from Electronic Health Record Systems Can Be Trusted in a Clinical Trial Setting
Applied Clinical Trials has published an article on the eCF eSource-Readiness Assessment (eSRA). eSRA is a list of questions, based on regulation and guidance from FDA, EMA, PMDA, and ICH for Clinical Research sites to self-assess their readiness to provide data from their electronic health records systems. This data may be electronically supplied to sponsors, or manually entered into a sponsor system, however if it originates in a healthcare system, then sponsors are responsible for assessing that these systems are appropriate.
eSRA Feedback Survey
Sponsors & CROs -- Please take a few minutes to complete this brief survey regarding how your company reviews site healthcare systems. We would like the input of every company whether you are using eSRA or your own assessment or not assessing at all.
Sites -- They survey is designed for Sponsors/CROs feedback, however, we really want your feedback as well!!! Please describe your feedback (positive or critical!) in an email to email@example.com
Thank you in advance for your help!
eClinical Forum eSRA Team (comprised of members from Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, OmniComm, Pfizer)
Technology Showcase: eClinical Solutions -- Enabling D-Clinical - Digital Data Strategy and the elluminate Clinical Data Hub
eClinical Forum announces Public Release of "Requirements for Electronic Data for Regulated Clinical Trials" & Public Webinar
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.
AGENDA AVAILABLE: eClinical Forum Europe Meeting in Brussels, Belgium 15-17 May 2019
Our European meeting of the eClinical Forum will take place in Brussels 15-17 May 2019.
Come along and see why our members are so excited... "ECF are the only meetings I attend each year. It gives me everything I need to stay current and to answer my questions" "People were amazing. Topics were great"
Please register your interest or contact the eCinical Forum for more information.
Expand the article for agenda and further details...
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 15-17 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)
APAC meeting date will be in November -- to be announced