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Pharmacovigilance Risk Management

Pharmacovigilance Risk Management & Drug Safety

Driven by a growing interest amongst regulators, consumers and the medical community, drug safety and pharmacovigilance risk management has risen dramatically in both importance and visibility over recent years.

In order to meet the increasingly complex and diverse global regulatory requirements, Aris Global has developed a comprehensive suite of integrated software solutions that enable all life sciences organizations, regardless of status or size, to implement effective domestic and global pharmacovigilance risk management programs.

Total Safety Software Suite
The Aris Global Total Safety suite is a modular suite of software solutions that supports all critical pharmacovigilance, clinical safety and risk management requirements. Each solution can be deployed independently, but when deployed together offers a comprehensive platform for pharmacovigilance and clinical safety that is compliant with the legal and ethical responsibilities of both Sponsors and Marketing Authorization Holders. Aris Global is the only company that can provide a true solution to support global pharmacovigilance in accordance with the specified guidelines encompassing case management, electronic reporting, aggregate report (PSUR) preparation and risk management.

Our software is fully compliant with international regulations supporting case management, report preparation, electronic submissions and benefit/risk management in accordance with international guidelines. The Aris Global safety suite is the industry leader, used globally by more than 100 customers with thousands of users. The core system, ARISg is the industry standard for large and small life-sciences organization with the largest install base.

The Total Safety Suite is a comprehensive suite of software solutions that support the legal and ethical responsibilities for pharmacovigilance and risk management. Total Safety is a platform to ensure compliance both minimizing and mitigating risk associated with safety concerns.
Drug Safety Pharmacovigilance
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