"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.
In 2001, a survey was conducted by the eClinical Forum to explore the experience, needs, views and issues of investigational site staff with respect to Electronic Data Capture (EDC).
Improved access to patient data is key to managing bottlenecks in clinical research. The presentation gives an overview of one of the largest public-private partnerships aimed at providing adaptable, reusable and scalable solutions for re-using patient level data from Electronic Health Record systems for Clinical Research.
Maintaining ECF expertise in the regulatory environment and trends
Companies engaged in commercial clinical research have, since the introduction of formalized good clinical practices (GCP), adopted highly defensive practices around the monitoring of clinical trials.
Practical Considerations for Clinical Trial Sites using Electronic Health Records (EHRs) certified for Clinical Research
The EHRCR Functional Profile Working Group is comprised of dedicated individuals from the United States and the European Union in the following industries: pharmaceutical, biotechnology, clinical research technology vendor, healthcare technology vendor, and federal regulator.
As the healthcare and pharmaceutical technology spheres move closer together at the clinical research interface, the eClinical paradigm needs to be revisited in order to leverage emerging political, cultural, procedural and technological opportunities. Understanding investigational site experiences with today’s clinical trial technologies and their perspectives on future requirements is critical to delivery of improved eClinical solutions
2009: EHRCR User Requirements Addendum, Draft 2, 16 April 2009
2009: HL7 EHR Clinical Research Functional Profile, Release 1
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eCF Birds-of-a-Feather Webinar: Site experience in the day-and-age of hybrid e-trials
Back by popular demand! Dr. van de Walle presented at the hybrid European eCF workshop in May … and we just ran out of time to answer all the questions! So many requests to ask Viviënne to present again with more time. So, here it is! Not to be missed! Viviënne is a full-time investigator and founder of an indepenent research site. She has vast site and patient experience and will share her insight into how hybrid trials are going for the sites and the patients.
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.
2024 Members Release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)
The "eCF Requirements" Members Release V2024 has been released. This is a significant accomplishment by the eClinical Forum’s “Regulatory Expert Group” (REG) as they have put in countless hours over many years to be able to produce such a comprehensive list of compliance requirements for electronic systems that will manage data used in regulated clinical research, against regulations and guidances from 40 different documents from FDA, EMA, PMDA, NMPA, MHRA and ICH and ISO.
Public release of the "Requirements for Electronic Data for Regulated Clinical Trials" (commonly referred to as the “eCF Requirements”)
The eClinical Forum is releasing its 7th public version of the “eCF Requirements” which takes all of the requirements and guidance directions that pertain to electronic data and electronic systems that support clinical research, from FDA, EMA, PMDA, MNPA, MHRA and ICH , and boils them down into 37 unique statements or "eCF Requirements".
eCF Birds-of-a-Feather Webinar: Protocol Optimization using AI/ML
We will be discussing the transformative potential of Artificial Intelligence (AI) and Generative AI in clinical development.
eCF Technology Showcase Webinar: OpenClinca “Unlocking Clinical Data from EHRs”
What if site users could launch the eCRF with a single click from the patient’s chart, and automatically populate CRFs with data from the chart? This is a Technology Showcase hosted by our newest eCF member, OpenClinica.
eCF Free Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments
The eClinical Forum is pleased to offer a free public webinar – to provide information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. 18-Sept-24: Registration Required.
eCF Americas Autumn Workshop 2024 Announced
Registration is open! Our Americas Autumn workshop will be kindly hosted by eClinical Solutions at their offices in Mansfield, Massachussetts (near Boston/Patriots Stadium) on October 22-24 2024.