Pharmacovigilance

Centralizes the major pharmacovigilance aspects, such as Adverse Reactions from post-marketing products and clinical trials, Periodic Safety Update Reports, Licensing Agreements and Medicinal Products database. Designed for both MAHs and for CROs who work for multiple clients and therefore need data separation between MAHs.

PharmaVigilance

Centralizing major pharmacovigilance aspects, such as Adverse Reactions from post-marketing products and clinical trials, Periodic Safety Update Reports, Licensing Agreements.

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BiblioVigilance

Medical literature monitoring for every country.

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Regulatory Compliance

E2B R3 compliant and validated software for a hassle-free experience.

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Central hub for Pharmacovigilance

Collect, analyze and report your safety data.

software icsr
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Available for MAH and CROs

Manage ICSRs as a Marketing Authorization Holder (MAH) or as a CRO working on behalf of multiple MAHs.

Export and report

Export your data in various formats such as CIOMS or E2B XML.

Data and settings
Designer

Fully customizable

Whether your organization requires capturing additional case information or has a custom case management workflow, PharmaVigilance can adapt to your needs.

Local and Global Medical Literature Monitoring

Bibliovigilance centralizes your weekly literature searches. Thousands of publications in virtually every country to fulfill your local and global search needs.

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Use a compliant software to ease your mind

E2B R3 compliant. Validated software. Support for validating your configuration. Focus on the science.