"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.
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.
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:
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 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.
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 firstname.lastname@example.org for registration information.
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 email@example.com
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!
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!
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.
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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
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.
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eCF "Birds-of-a-Feather" Round-table Discussions and Technology Showcases 2020 to 2021
“Birds-of-a-Feather” Webinars are provided monthly, to get those with similar interests together. Anyone from an eCF member company (around the globe!) can participate, gratis. All eCF members can suggest a topic and/or lead a discussion.
Public Release: Audit Trail Review: Key Tool to Ensure Data Integrity Version 1.0
The Society for Clinical Data Management (SCDM) and eClinical Forum (eCF) Joint Task Force are pleased to announce the publication of an industry position paper “AUDIT TRAIL REVIEW: A KEY TOOL TO ENSURE DATA INTEGRITY” final version based on Industry Feedback. With various electronic data capture modalities becoming the norm and the growing regulatory focus on data collection traceability, audit trails which capture the who, what, when, and why of electronic data entry and amendments are a critical tool. This paper outlines an industry perspective on maximizing the value of implementing the targeted, routine review of these extremely large datasets. It provides recommendations on risk-based use cases for audit trail review (ATR) and the corresponding desired reporting criteria, with suggestions on when to use visualizations and exception report listings to generate key, actionable insights.
eCF Free Public Webinar: Requirements for Electronic Data for Regulated Clinical Trials, and associated Investigator Site eSource-Readiness Assessment
The eClinical Forum is pleased to offer a free public webinar – the same as was presented to the FDA CDER Health IT Board on 6-April-2021 – to provide information on our 2 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials) and eSRA (Site eSource-Readiness Assessment).
REGISTRATION IS OPEN: eClinical Forum Virtual Spring Workshop, 4-18 May 2021
We are pleased to announce the details of our next Virtual Global Workshop on 4-18 May 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 in 2020 were 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 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