Latest iTrial EDC includes new PDF Audit Trail function

Almac Clinical Technologies have announced the release of their latest iTrial EDC™. Among the upgrades is the newest version of Almac’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 to complement data submitted for a New Drug Application (NDA).

In his recent presentation at DIA’s Clinical Data Management Symposium, Armando Oliva, Deputy Director for Bioinformatics of the FDA discussed the value of audit trails within eCRF’s submitted in PDF format. He explained that sponsors do not typically include audit trails in PDF format.

Almac’s iTrial EDC™ allows sponsors to view all data captured with a full audit trail and also to select and view the audit trail only for data that has changed. The tool includes powerful hyperlink capabilities which allow viewers to link to altered fields and associated comments as well as clinical queries.

Jim Murphy, President of Almac Clinical Technologies, said:

“Our most recent PDF generation enhancements are another example of Almac’s commitment to the highest standard of data integrity and transparency.”

“As regulatory standards across the world place higher demands on those undertaking Clinical Trials, at Almac we are working to ensure that our clients are kept at the very top of the curve,”

he added.

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Contacts

Carl Whyte	Meghan Adams
Stakeholder Communications	Almac Clinical Technologies
+44 (0)28 9033 9949	+ 1 267 685 4284
[email protected]

About Almac

Almac Clinical Technologies is a division of Almac that specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS™) for patient randomization, tracking and clinical supply management, iDiary for phone-based electronic patient reported outcome data collection, and iTrial EDC™ for electronic case report form data collection.

Almac Group and its affiliated companies (Almac Diagnostic Services, Almac Sciences, Almac Clinical Services, Almac Clinical Technologies and Almac Pharma Services) provide a broad range of services across drug discovery, diagnostics, pharmaceutical research and development, manufacture of API, clinical trials and drug product manufacture. US operations are based in Pennsylvania, North Carolina and California. European operations are headquartered in Craigavon, Northern Ireland with additional operations in London and Edinburgh.