"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.
Registration is open for the eCF Spring Workshop, kindly hosted by Boehringer Ingelheim at their Ridgefield, Connecticut campus on April 30 to May 3, 2024.
This workshop is hosted by BSI Life Sciences at their office in Zurich, Switzerland on April 16-18. It will also be live-streamed and recorded for access by all eCF members.
Europe/Global hybrid workshop -- April 16-18
Americas in-person workshop -- April 30 - May 2
eClinical Forum's two-day APAC Workshop was held in Kobe on 13 & 14-Nov-2023. The workshop was such a great success, thanks to generous and attentive hosting by Eli Lilly and thanks to all the participants from sponsors, investigator sites and system integrators who made contributions through thought-provoking presentations, intelligent comments/questions and friendly discussions. Thank you all and see you at next year's workshop!
eClinical Forum's Autumn Americas Workshop last week at Janssen in PA was terrific! It was so dynamic with participants from so many different eCF members companies presenting, discussing, networking and generally having a good time together. We had participants from Acadia, AiCure, Amgen, Astellas, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Clario, CSL Behring, Early Access Care, eClinical Solutions, GSK, J&J/Janssen, Medidata, Memorial Sloan Kettering, Merck & Co, Merck KGaA, Safira, and Uniphi. But, still we missed our members who could not attend ... Abbvie, Alexion, Ferring, Oracle, Novartis, Pfizer, Signant Health, and Veeva. I look forward to more collaborating over the winter and to be together in the Spring!
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.
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eCF Views & News
We send out a brief monthly newsletter via email to all our active eCF members to keep them abreast of the activities of eCF that they can participate in. The more who participate, the better we are "A Network Powered by Peers". Click to see the most current newsletter.
eCF Birds-of-a-Feather Webinar: EHR-EDC Integration – Implementation Overview and Learnings
Implementing EHR-EDC integrations is an emerging area of focus in the pharma industry. This presentation will share an overview of implementing an EHR-EDC integration on 2 studies and the associated lessons learned. Following this overview will be a group discussion on such integrations and prospects for broader adoption within our clinical trials.
eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023
The eClinical Forum is happy to announce the Public release of the "eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023"
ABOUT THE ECF REQUIREMENTS: The eClinical Forum has produced a set of Requirements, which are based upon statements in regulatory documents that pertain to the design, development, implementation, and management of electronic systems that support clinical research data as well as those statements that pertain to the handling of data that will be used in a regulated clinical trial. We have reviewed regulatory documents from the FDA, EMA, PMDA, NMPA, MHRA and ICH to produce this set of requirements. Each Requirement has as its basis one or more statements from one or more of these regulatory documents. The Requirements can be used to determine if systems, that source or manage data which will become part of a regulated clinical trial, are consistent with regulatory requirements and if systems and process that manage these data have the necessary features.
eCF Spring Workshops Announced
eCF Spring Workshop in Zurich, Switzerland
eCF Spring Workshop in Ridgefield, Connecticut USA