Your Partner in Seamless Pharmacovigilance Data Management
In the rapidly evolving field of pharmacovigilance, the effective management of safety data is critical to ensure compliance with regulatory standards and safeguard patient health. At BioVigilant Pharmacovigilance, our Safety Database Services are designed to meet the complex demands of modern pharmacovigilance, providing robust, compliant, and efficient database solutions tailored to your needs.
Comprehensive Safety Database Expertise
Our team brings extensive experience across industry-leading pharmacovigilance databases, ensuring seamless integration and data management:
- Supported Databases: Expertise in Argus, Aris Global, Clinevo, Safety Easy, LifeStream, and more.
- Compliance Standards: Fully ICH E2B (R3) and HL7 compliant to meet international regulatory requirements.
- Outputs: Delivery of regulatory-ready outputs, including:
- XML Export
- CIOMS
- MedWatch (3500A)
- Periodic reports such as PSUR, DSUR, IND Annual, and NDA Periodic.
We also offer the flexibility to work with other pharmacovigilance databases, ensuring tailored solutions for every client.
Our Core Services
User Documentation Creation
We develop comprehensive user manuals and documentation to empower your team with the knowledge to navigate safety databases effectively.
Testing and Performance Qualification
Robust testing ensures that your safety database functions flawlessly under all scenarios.
Database Configuration
Tailoring your safety database to fit your specific needs is our priority.
Hosting Services
Secure and reliable hosting ensures your database is always accessible and protected.
Key Advantages of
Choosing BioVigilant
At BioVigilant Pharmacovigilance, we believe in more than just providing database services—we are your compliance partners, dedicated to delivering excellence in safety data management. Our proactive approach ensures that your safety database meets the highest standards of accuracy, efficiency, and reliability.
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