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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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(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)
«March 2022»
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MEMBERS: Submission of comments to FDA on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

MEMBERS: Submission of comments to FDA on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

The eClinical Forum RWE Team discussed Docket No. FDA-2021-D-1128 “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations; Draft Guidance for
Industry, Investigators, and Other Stakeholders; Availability”.  The resulting comments are a consensus of member opinion. They have been submitted to the FDA on March 8, 2022.

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eCF BoF Round-Table: Suppliers/Vendors Oversight: Best Practices

eCF BoF Round-Table: Suppliers/Vendors Oversight: Best Practices

Facilitator:           Manuela Hornberger, Boehringer Ingelheim   

Open To: Staff from eClinical Forum member companies gratis  (If you are not an eCF member, please review our website www.eclinicalforum.org/membership for membership information or contact info@eclinicalforum.org )

Background: eClinical Forum webinar sessions focus on the details of a specific topic.  All participants are encouraged to share information and ask questions. Anyone from an eCF member company can participate, gratis. The facilitator will [try to] keep the subject on track and prompt discussion and information sharing.

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eCF Technology Showcase: eClinical Solutions - "Leveraging a Digital Accelerator

eCF Technology Showcase: eClinical Solutions - "Leveraging a Digital Accelerator

eClinical Solutions Technology Showcase: As the volume, variety and velocity of data sources available for use in clinical research have grown, the need has arisen for a modern data infrastructure that automates data processes from ingestion through submissions.  75% of Life Sciences companies are still using Excel and SAS to integrate data sources slowing time to insight for data review teams, reducing collaboration and extending traditional cycle time metrics like LPLV to DBL.

eClinical Solutions, and eClinical Forum Member company, offer elluminate Clinical Data Cloud as a foundation of modern digital trials. This session will demonstrate the numerous capabilities in the platform that replace manual processes in the data lifecycle. They will share frequent uses cases and the business outcomes data management, medical monitoring, statistical analysis and clinical programming and clinical operations teams experience when using the elluminate Clinical Data Cloud.   

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Members Release: Best Practice Document on Investigator’s Signature

Members Release: Best Practice Document on Investigator’s Signature

The eClinical Forum is happy to announce the release of the "Investigator’s signature on electronic Case Report Forms (eCRFs), MR2022”.

About the Best Practice Document: There is increased scrutiny by regulatory agencies on the collection of investigator’s signatures as evidence of the overall oversight on the eCRF is reported to the sponsor.  eClinical Forum PI Signature Working Group was formed in March 2021 to update the best practice document originally issued in 2017 by identifying best practices that are based on compliance to regulatory requirements and on risks such as reputation, credibility, legal liability of the data being used by the sponsor. 

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