eCF Views:

        A few new discussion topics are waiting for responses!  Please add your thoughts! (or add another question!)

• eCRF Edit Checks and Cross-checks
• Inter-company quality analytics around data
• Use of clinical study data in medical evaluation
• Performing IRT/eCOA UAT in a remote work environment
• FDA Inspector comments on contents of PDFs
• What are YOU wondering about ... please post your thoughts and get a conversation going!

Please login to the  Discussion Forums (eclinicalforum.org) to respond or to read the full discussion … (You will need a member account to login … but it’s easy to get one .. just register via  Home (eclinicalforum.org) … it can take up to 2 business days for your account to be confirmed.)

 eCF News:

• eCF Japan workshop…  Last-minute registration is still available!  Nov 11-12 near Tokyo, Japan. For more information and to register: eCF APAC Autumn Workshop 2024 (eclinicalforum.org)  Please contact Sean.Higashio@eclinicalforum.org  for more information.
• Europe hybrid Autumn workshop was held on Oct 15-17 in Ingelheim, Germany. A huge success! Thank you to Boehringer Ingelheim for hosting us. 28 people participated in-person with 52 joining the live-stream at different points in the 3-day workshop. Slides of the presentations are available in the Document Repository (on the login-side of our website).
• Americas Autumn workshop was held on October 22-24 in Mansfield, Massachusetts. Thank you to eClinical Solutions for hosting us! 32 people joined in-person. A post-meeting text from one of our first-timers was much appreciated “The meeting was one of the best I’ve been to and a testament to the hard work of this organization. I loved the discussions and enjoyed meeting so many wonderful people along the way.”  Presentation slides are in the Document Repository once you login to the website.
• Online round-table discussion “Risk Based Approach to SDV” on Thurs, Nov 21. This is a request from the eCF workshop in Massachusetts, and will be an informal discussion. It will be held once at EST 10am / CEST 16:00. For more information and to register: eCF BoF Round-Table Risk-based SDV
• FDA public webinar on Real-World Evidence on Nov 22 at 1pm EST: Real-World Evidence Webinar Series: Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice | Reagan-Udall Foundation
• “Think GCP” webinar on ICH E6 R(3) on Thurs, Dec 5 or Mon, Dec 9 by Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3). This will occur at 2 times: Dec 5 at UTC 0900 and Dec 9 UTC 1600. NOTE: Webinar B is a change from the previously announced date … it is now being held on Mon, Dec 9 at 8am PST, 9am MST, 10am CST, 11am EST, 1pm BRT, 1600 BST, 1700 CET, 1800 CEET, 2130 IST.  It will not be recorded, so please block out your calendar! To register: eCF "Think GCP" Webinar: ICH E6(R3) (eclinicalforum.org)

• eClinical Solutions, an eCF member company, is conduction a survey on “Industry Outlook 2025: The Future of Clinical Data”.  They will donate $25 to the American Heart Association for each response. Please help them and the AHA out by participating! (I’m sure we can get them to present their results to us…) Thanks!  https://survey.alchemer.com/s3/8008191/2ccb34951a58
• Invoices for the 2025 eClinical Forum membership dues will be sent out to the primary representative from each member company during November. The eCF Steering Committee has decided not to change the fees or fee structure from 2024. We ask that all membership fees are kindly received by the end of Q1 2025 in order to not disrupt services to our members. For more information, please contact Adam.Perkins@eClinicalforum.org .