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
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.
FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies
June 18th 2025Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.
