Quanticate Description
Quanticate delivers extensive services in pharmacovigilance, which include the establishment and oversight of safety databases specific to pharmacovigilance. These safety databases act as the primary collection point for individual case safety reports gathered worldwide for a company's pharmaceutical products. Keeping these databases current with the latest regulatory guidelines and ensuring they are validated according to international standards and business requirements is crucial. Quanticate underscores the necessity of choosing the appropriate database by evaluating factors such as the costs associated with implementation and maintenance, the availability of hosting models (including internal infrastructure, third-party hosting, or vendor cloud solutions), previous experiences, and how well they integrate with existing systems. They warn that, despite many commercial databases claiming adherence to standards like ISO ICSR ICH-E2B, achieving genuine compliance necessitates meticulous configuration, validation, and ongoing management. Furthermore, ongoing support and updates are critical to maintain the integrity and reliability of these safety databases over time.
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SDS Manager
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TARA PV
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IQVIA
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Company Details
Company:
Quanticate
Year Founded:
1994
Headquarters:
United Kingdom
Website:
www.quanticate.com/pharmacovigilance-safety-database
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Product Details
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Web-Based
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Online Support
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