eShowcase: iTrial EDC

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.