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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.
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.
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?
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
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.
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
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。
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.
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.
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.
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 firstname.lastname@example.org. Thanks!!
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?
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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eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research
A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.
Japanese translation of eSRA V2023
Version 2023.2JP1 (18-Sep-2023)
Japanese translation of eSRA Handbook and Assessment Questionnaire (eSRA日本語訳)
Birds-of-a-Feather Presentation and Discussion: Audit Trail Review Tools
The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.
eClinical Forum Hybrid Workshop, Barcelona, Spain
We are pleased to announce that registration is now open and the agenda is available for our next European Workshop in Barcelona, Spain on October 4-6 hosted by Veeva Systems
This hybrid workshop is available for face-to-face or remote participation.
Please note...Presentations will be recorded and published in the member section of our Website after the workshop. Remote participation cannot replicate the experience of face-to-face participation and we encourage you to attend in person if you can.
We encourage you and your colleagues to REGISTER NOW
Download Agenda HERE
Americas Autumn Workshop
eClinical Forum Autumn Workshop, Spring House, Pennsylvania
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Janssen in Spring House, Pennsylvania on October 24-26 2023.
This is an in-person workshop. There will be networking/social events on both evenings. Each eCF Member company in the Americas region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. Information on the European workshop will be on our website soon.
eClinical Forum Autumn Workshop, Kobe, Japan
We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Eli Lilly in Kobe, Japan on November 13-14 2023.
This is an in-person workshop. There will be networking/social events on the first evenings. Each eCF Member company in the APAC region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded.
eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”
This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.