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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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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!!
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Birds-of-a-Feather Webinar: Tufts-eClinical Solutions "Data Strategy and Transformation Study Results"
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.
We have recently learnt that fraudulent Emails have been sent out with eclinicalforum.org addresses. The security issue has now been fixed, however, please be vigilant if you have received Emails during April and May purportedly from the eClinical Forum if they are asking for payment or personal information.
Please don’t hesitate to contact us at email@example.com if you have any questions or concerns.
Success! eClinical Forum 2020 Spring Meetings replaced with Virtual Global Workshop 11-13 May 2020
Birds-of-a-Feather Round Table Discussion: New recommendations from EMA on the frequency of investigators’ signature collection on eCRF data
In July 2020, EMA released a new Q&A to provide further expectations on continuous oversight and frequency of investigators’ signature collection on eCRF data reported to the sponsor. Prior to filing a marketing authorization application, all eCRF data should be signed and dated. But also important data such as that related to reporting of SAEs, adjudication of important events and endpoint data, DSMB review, should be signed off in a timely manner. In addition, a timely review and sign-off of data that are entered directly into the CRF as source is particularly important.
The intent of this webinar is to identify if there are new challenges, and if any – to proceed with an update to the eCF best practices on investigator signatures document that was released in 2017.