Safety Document Management, Workflow and Distribution

Available from IntraLinks, Inc.

Document management, workflow and distribution solutions from Intralinks include Studyspace, a secure, agile and efficient platform for managing the flow of critical safety documents. Intralinks Studyspace allows investigators and safety teams to securely submit reports to sponsors in real-time, speeding information exchange and collaboration when serious events occur. Intralinks Studyspace decreases the time needed to receive and disseminate severe adverse effect (SAE) reports, ensures secure communication, provides automatic notification of reports and receipt, and helps ensure documents are reviewed in a timely fashion. In addition, sponsors of widely dispersed global trials using multinational CROs can track document distribution with full audit trails, and ensure regulatory compliance across multiple jurisdictions. Additional features include:

Workflows to support collaboration by automatically routing SAE reports for internal review;

Automated distribution of complete SAE report to investigators, IRBs, and CROs;

Audit reports that maintain records of report distribution, recipient delivery status, document access, and timing to improve compliance;

A centralized, repeatable and scalable platform for managing SAEs;

Connectors to leading safety systems which facilitate the seamless routing of SAEs to the sponsor’s review team for evaluation.

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