"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.
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
A lot has happened in electronic support for clinical research in the last 20 years ... and eClinical Forum has been there discussing it all! We are pleased to be celebrating our 20th anniversary year, stronger than ever with 45+ member companies (and growing), meetings on 3 continents, global webinars that have been attended by members in over 25 countries, very active project teams, meetings with regulators, and freely adding to the knowledge base of the industry. Any organization working in this space is welcome to join. Please see the membership tab on our website (www.eclinicalforum.org) or contact us for more information! info@eclinicalforum.org
As there are no regulatory detailed expectations on oversight by investigators on eCOA data, multiple approaches have been adopted across the industry (from log-in as evidence to notification/alerts or investigator signature on eCOA data). In general, as per other data sources, oversight for eCOA data should be continual and not once at the end of the study. In addition, oversight activities should be right-sized according to the criticality of the data and protocol requirements for compliance. Evidence of the oversight should be available during the conduct of the trial and enduring for the entire retention period. The aim of this webinar is to allow participants to share different approaches and any knowledge of current expectations by regulatory inspectors.
This meeting is being replaced with a Virtual Global Workshop on 11-13 May 2020.
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.
For more information on our Virtual Global Workshop, please contact info@eclinicalforum.org.
North America: Oct 2-4 in Philadelphia, Pennsylvania USA hosted by CRF Health
Europe: Oct 23-25 in Paris, France hosted by Servier
Asia Pacific: Nov 5-6 in Tokyo Japan
Agendas will be decided a few months prior. For more information or to suggest agenda topics, please contact info@eclinicalforum.org
We had a fabulous level of participation with well over 50 members online from California to Japan participating in our Technology Showcase exploring electronic informed consent and demonstrating Enforme Interactive/Drug Dev’s SecureConsent Application for eICF. Some good discussion helped us to understand the business opportunities and value. Materials are available for download. Expand the article to read more about the event.
The meeting this week (Oct 24-26), hosted by Clinical Ink at Normandy Farms, was truly outstanding. With 31 different organizations participating, including guests from 3 investigator sites and a Patient Advocacy group, and members from large pharma, bio-pharma, CRO, and software vendors, the discussions took on many levels and perspectives. We took on issues with new technologies, innovation, patient-centricity, and site processes and technologies, all living under the umbrella of regulations and privacy laws. We also tackled a team-building cooking adventure and did a lot of networking! Our meeting numbers continue to grow with this being the largest meeting for the NA eCF Forum yet, and the post-meeting evaluations consistently show that members appreciate the candor of sharing of information and breadth of topics provided.
The eClinical Forum is a "Network Powered by Peers" and our workshops offer a unique balance of detail and vision, learning and cooperation, ideas creation and innovation. Meetings have always achieved near perfect ratings from members and the workshop in Basel 10-12 October 2016 was no exception. Our largest European meeting yet and one of the highest scoring! Expand the article to see member feedback and the topics discussed.
The eClinical Forum holds several workshops/year, typically hosted at one of the member sites. Our Autumn 2013 European meeting is being hosted by ICON at their offices in Dublin, Ireland on Sept 18-20.
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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