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iVigee offers an expert Oracle Safety Database service to provide a complete, customised, turnkey system, or a seamless transition from your current system. After analysing your current system design and technology, and consulting with you about what you need from your new Argus system, we create a customised system implementation and migration service to meet your business needs.
Our Argus implementation team will develop and execute a fully validated, 21 CFR Part 11/Annex 11-compliant, problem-free system with our proprietary validation package and procedures, configuring, testing, and providing system integration services according to your goals and timeline.
Our Argus migration services differ based on your safety data strategy, ensuring an efficient transfer that maintains full data integrity. No matter how complex your needs, we have the capability to perform a complete migration of safety data from your source database.
Leveraging our expertise in IT, pharmaceutical operations, and pharmacovigilance reporting, we can offer a complete pharmacovigilance database solution that enables you to work with multiple CROs seamlessly without the need to move your safety data. Our experts save you time and resources so you can stay focused on your core competencies.
We support you every step of the way, from initial validation and implementation of your safety system to filing your first periodic report to providing guidance during regulatory inspections. Day to day, you’ll have service you can rely on — in hours, not weeks. We’ll be there, on site if you need us, to support your drug safety compliance through your product’s life cycle.
We offer a range of flexible pricing options to guarantee you get the most value based on your unique business needs. For clients that anticipate a small number of required system changes and analytic support, time and materials pricing may be the most cost-efficient model . For clients that anticipate larger volumes, or that wish to have one static cost for budget planning, our fixed-pricing model includes packaged quantities of system changes and analytics.
We listen, we give you options, pros, and cons, honestly discuss short-, mid- and long-term consequences, and then we plan, implement, check every step for you so all goes as agreed, and we continue to care to establish a long-term relationship.
We use the best proven solutions and tools making sure all is fit for purpose as per GxP and business requirements.
We have done dozens of implementations. Please, reach out to gain list of references!