eShowcase: iTrial EDC
Latest iTrial EDC Includes New PDF Generation Tool to Improve Audit Trail Function
Latest iTrial EDC Includes New PDF Generation Tool to Improve Audit Trail Function
Almac Clinical Technologies' (Yardley, PA) latest iTrial EDC release features the newest version of the company's PDF Generation Tool, which is consistent with current FDA eSubmission guidance.
This tool allows sponsors to generate PDFs of their electronic case report forms (eCRFs) for site archival purposes, as well as to complement data submitted for a New Drug Application (NDA).
iTrial EDC allows sponsors to view all data captured with a full audit trail and also to select and view the audit trail for only the data that has changed. The tool includes hyperlink capabilities, which allow users to link to altered fields and associated comments as well as clinical queries.
FDA recently discussed the value of audit trails within eCRFs submitted in PDF format, which sponsors do not typically include.
Almac Clinical Technologies, (267) 685-4284, www.almacgroup.com
Tirzepatide Demonstrates Superior Weight Loss to Semaglutide in 72-Week Phase IIIb SURMOUNT-5 Trial
May 12th 2025In the first head-to-head comparison of leading incretin-based therapies, Eli Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide (Zepbound) delivered significantly greater and sustained weight loss than semaglutide (Wegovy) over 72 weeks in adults with obesity or overweight and comorbidities.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.
