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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.
Japanese Translation: eSRA Handbook and Assessment Forms V2025.2
の日本語版2025.2JP1が2025年6月30日にリリースされました。
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eCF "BoF" Round table: "A Chat about eCOA"
eClinical Forum Birds-of-a-Feather round-table webinars 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.
Birds-of-a-Feather Round-table on eCOA Topics
Open To: Staff from eClinical Forum member companies gratis (If you are not an eCF member, please review our website Membership for membership information or contact info@eclinicalforum.org )
eCF Webinar: "Strategies for Implementing Audit Trail Review"
The eCF Audit Trail Review Analytics (ATRA) team anticipates releasing their white paper "Strategies for Implementing Audit Trail Review" to eCF members in early September. This webinar will provide an overview of the paper as well as delve into some specific areas.
eCF Autumn Workshops Announced!
We are happy to announce our 3 Autumn workshops!
Americas: Hosted by Eli Lilly in Indianapolis on October 21-23
Europe/Hybrid: Hosted by Medidata in London on Nov 4-6 (this will be livestreamed as well)
Asia: Hosted by Kyowa Kyrin in Tokyo on Nov 13-14