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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.
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. The reasons, while diverse, include fear based on perception and interpretation of regulatory requirements. These processes have played a very large role in the high costs associated with clinical trials, without delivering commensurate value. Reasons are many, but surely include propagation of practices established during the years that trials relied on paper-based case report forms (CRFs) without considering optimization of the processes to take advantage of the technology provided by electronic data capture (EDC). All of this has resulted in the institutionalization of high cost, unproven value, manpower-intensive practices that do little to serve the interests of subject safety or quality data. Pharmaceutical, biotech, and medical device industries experiencing unprecedented economic upheaval can no longer justify practices that deliver little value at exorbitant cost. Rather than continuing to spend time, energy, and money focusing on minutiae, e.g., the ability of site personnel to properly transcribe observations from one medium to another, those engaged in clinical trial conduct must re-focus their energies on the aspects of the clinical trial that matter most, such as protocol compliance, subject safety, data timeliness, and data integrity. Through the use of more up-to-date methodologies and technologies, companies can effectively address these concerns while saving both time and money. This paper addresses the regulatory and business rationales for adopting monitoring-related tools and processes that, if implemented thoughtfully, should deliver higher-quality trial data, faster, and at significantly lower cost.
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eCF Technology Showcase: The Impact of AI Driven Automation and Data Transformation - A Guided User Experience for Automated Mapping
eClinical Solutions, and eCF member company will present an approach to AI that aims to bridge that gap – a guided user experience for automated mapping.
The eClinical Forum is happy to showcase their members, however does not promote nor endorse any particular technology solution.
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members
Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)
About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.
eCF Webinar: Audit Trail Review – Is your Audit Trail fit for purpose?
Date: Thursday, February 20, 2025 Duration: One hour
Presenter: Dr. Torsten Stemmler, head of GCP inspections at the Federal Institute for Drugs and Medical Devices (BfArM)
Dr Torsten Stemmler has been involved in GCP inspections since 2017 and has contributed to various European guidelines (e.g. Guideline on computerised systems and electronic data in clinical trials). He has a background in data management and neurobiology (specialising in psychophysics). He is currently working on GCP inspections and artificial intelligence in the EMA eSubgroup.
eCF Technology Showcase: AiCure: Using AI to improve patient adherence, compliance, and retention
AiCure, and eCF member company will present how their software uses AI to improve patient adherence, compliance, and retention.
eCF Spring 2025 Workshops Announced
We are pleased to announce our 2025 Spring Workshops.
These workshops will be in-person, with the UK workshop also being live-streamed for any eCF member around the globe to join. Each eCF member organisation has a certain number of seats available for in-person participation, depending on the membership type (please contact your eCF Primary representative to discuss using a member seat). Joining the UK workshop via live-stream is gratis for anyone in an eCF member organisation.
April 29-May 1: King-of-Prussia, PA, USA (kindly hosted by CSL Behring)
May 13-15: Walton Oaks, Surrey, UK (kindly hosted by Pfizer)