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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.

 

NEWS FROM THE ECF

eCF Americas Autumn Workshop -- loads of information, networking and fun

Hosted by Janssen in Spring House, PA October 24-26 2023

eCF Americas Autumn Workshop -- loads of information, networking and fun

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!

eCF Technology Showcase: Veeva Systems “End-to-End Clinical Data: Connecting Patients, Sites, and Sponsors”

Tuesday, 12-December-2023 Duration: One hour

eCF Technology Showcase: Veeva Systems “End-to-End Clinical Data: Connecting Patients, Sites, and Sponsors”

This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Veeva Systems, an eClinical Forum member company, will showcase their end-to-end solution for patients, sites, and sponsors. The eClinical Forum does not promote nor endorse any particular technology vendors.

eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”

Webinar: Thursday, 16-November-2023 

eCF Technology Showcase: Viedoc Technologies AB – “The integrated eTMF/eISF to control study documentation management”

This is an eClinical Forum Technology Showcase. Our Technology Showcase sessions have been requested by eCF members to provide a demonstration of products or services. Viedoc Technologies, an eClinical Forum member company, will showcase their e-Trial Master File/e-Inestigator Site File solution. The eClinical Forum does not promote nor endorse any particular technology vendors.

eClinical Forum Autumn Workshop, Spring House, Pennsylvania

October 24-26 2023

eClinical Forum Autumn Workshop, Spring House, Pennsylvania

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Janssen in Spring House, Pennsylvania on October 24-26 2023.

This is an in-person workshop. There will be networking/social events on both evenings.  Each eCF Member company in the Americas region will have 1 or 2 seats at this workshop. For those wishing to attend a remote eCF workshop, the eCF European workshop on Oct 4-6 will have similar topics and will be live-streamed and recorded. Information on the European workshop will be on our website soon.

Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

Thurs, 21-Sept-2023

Birds-of-a-Feather Presentation and Discussion:  Audit Trail Review Tools

The facilitators will share their experiences with the Boehringer-Ingelheim audit trail review tool … how it was developed, how it is being used, and what are the benefits. They welcome and encourage an open discussion on what tools and procedures other organizations are using for audit trail review.

eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

29 August 2023

eCF Focus Session: EMA Guideline on Computerised Systems and Electronic Data in Clinical Research

A member from each eCF Project Team will present significant items in this guideline, from the perspective of their team topic.

 

eCF Tech Showcase: eClinical Solutions "Automating your end-to-end data flow"

27 July 2023

eCF Tech Showcase: eClinical Solutions "Automating your end-to-end data flow"

Stakeholders across clinical development along with patient advocates and regulators are energized by the rapid progress the industry has made and the possibilities of technology to speed the overall clinical development process and more fully deliver on the promise of personalized medicines. But, as the volume, variety and velocity of data continues to change in research, so has the need for more modern scalable technology. Data proliferation along with dwindling resources has made it a top priority for clinical development teams to look to technology to improve cycle times and the overall experiences across clinical teams and functions.  This Technology Showcase will highlight eClinical Solution’s elluminate® Clinical Data Cloud, which provides a centralized location for all trial data, across all sources, creating scalable and unified architecture for seamless data flows and an interoperable ecosystem of tools and capabilities.

eCF Technology Showcase: Veeva Systems "Improving the Site-Sponsor Relationship Through Connected Technology"

March 23, 2023

eCF Technology Showcase: Veeva Systems "Improving the Site-Sponsor Relationship Through Connected Technology"

The current technology landscape is becoming more unsustainable for research sites, who are inundated with cubbies of paper binders and a growing number of systems to manage. At the same time, sponsors want to work more efficiently with sites without adding to their already heavy workload.  In this one-hour webinar, eClinical Forum member, Veeva, will show how sites and sponsors are saving time, reducing redundant work, and working together by using Veeva’s connected technology for improving the site-sponsor relationship.

eCF Technology Showcase: BSI Life Sciences - "Onboarding a combined CTMS and eTMF”

Tues, 18-April-2023

eCF Technology Showcase: BSI Life Sciences - "Onboarding a combined CTMS and eTMF”

The digitalization of clinical trials and operations has been at the forefront of pharmaceutical and med-tech modernization strategies over the last two decades. However, many companies are still struggling to digitize their clinical operations for various reasons: old habits, fear of adopting and rolling out an electronic solution, potential delays on deadlines, or concerns about quality and compliance. eCF Member BSI will share their thoughts on why a unified CTMS and eTMF is crucial in running clinical trials in the age of digitization and technology, while providing examples with their CTMS and eTMF.  

eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

May 15-17, 2023

eClinical Forum In-Person and Remote Workshop, Blue Bell, PA

We are pleased to announce our next Americas Workshop in Blue Bell, PA USA on May 15-17 kindly hosted by Signant Health.

This workshop will be available for face-to-face and remote participation.

We hope you can join us!

eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials

Tues 28-February-2023

eCF Webinar: Artificial intelligence can improve patients’ experience in decentralized clinical trials

The clinical trial industry is undergoing a rapid transition toward decentralization, where some or all health assessments are performed remotely in participants’ homes instead of in medical centers. Adopting artificial intelligence in this setting can empower more patients to enroll in trials, successfully complete them without burden, and submit high-fidelity assessments of their health. In this talk, the presenters will discuss insights from their recent article in Nature Medicine on this topic.  The article can be viewed at: Artificial intelligence can improve patients’ experience in decentralized clinical trials | Nature Medicine

eCF Webinar: Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)

30-January-2023 at UTC 1500

eCF Webinar: Assessing e-Investigator Site Files for compliance with regulatory expectations (eCF eISFQ)

The intention of this webinar is to introduce you to the newest eCF Site Assessment -- the draft eInvestigator Site File Questionnaire (eISFQ). Each question in the eISFQ is based on regulatory authority document statements. It is intended for sites to self-assess their eISF such that sponsors can determine if it is suitable to use for their regulated clinical trials. The eCF eISFQ Team intends to start a pilot with the the eISFQ in late 1Q '23. We would like to present this information to our members to get your feedback and to inspire interest in participating in the pilot.

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eCF Views & News

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.

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eCF Birds-of-a-Feather Webinar:  EHR-EDC Integration – Implementation Overview and Learnings

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. 

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eCF Requirements for Electronic Data for Regulated Clinical Trials PR2023

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.

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