Adverse Event Reporting, Safety And Compliance Software

Adverse event (AE) reporting is a key process point for maintaining safety and compliance. Unfortunately, it’s also incredibly labor-intensive. AE source documents arrive in just about any form—mail, fax, email, even voice records from call centers. “Unlocking” these source documents from paper and isolated directories has become an imperative in the pharmaceutical industry for scaling global operations and managing CROs. That’s where Sitrof Safety Capture comes in.

Sitrof Safety Capture & Oracle® Argus Safety
Sitrof Safety Capture, in conjunction with Oracle Argus Safety, improves your company’s end-to-end pharmacovigilance program by providing a holistic view of product stewardship—from clinical trials through post-marketing surveillance.

Sitrof Safety Capture transforms unstructured AE source documentation into easily searchable digital records, and automatically creates entries in the Argus Intake Worklist. From the Intake Worklist, users can instantly create a case from the source documentation, or reject the document.

Features Of Sitrof Safety Capture

• Imports all AE source data regardless of original format—paper, digital, fax, e-fax, email (with or without attachments)—as well as voice records from call centers
• Supports combining multiple email attachments into a single document or splitting into multiple documents
• Supports both high- and low-volume capture requirements
• Compatible with most mid- and high-volume scanners and multifunction devices
• Allows for user-supplied metadata about AE source data, such as country, classification type and product
• High availability technology maximizes system availability and minimizes disruption