Audience
Pharmaceutical companies and clinical research organizations needing a solution for managing safety data across the lifecycle of their medicinal products
About Quanticate
Quanticate offers comprehensive pharmacovigilance services, including the provision and management of pharmacovigilance safety databases. A pharmacovigilance safety database serves as the central repository for individual case safety reports collected globally for a company's medicinal products. It is essential that these databases are up-to-date with the latest regulatory requirements and validated to meet international standards and business needs. Quanticate emphasizes the importance of selecting the right database by considering factors such as implementation and maintenance costs, hosting model availability (internal infrastructure, third-party hosting, or vendor cloud options), prior experiences, and compatibility with other systems. They caution that while many commercially available databases claim compliance with standards like ISO ICSR ICH-E2B, true compliance requires careful setup, validation, and management.
Other Popular Alternatives & Related Software
PvEdge
PvEdge is a cloud-ready pharmacovigilance software designed to provide end-to-end compliant safety solutions for drugs, devices, vaccines, and combination products. It offers a comprehensive safety database that manages pharmacovigilance intake, case processing, submissions, AI & analytics, and safety signals all in one platform. The system adheres to existing and upcoming regulations, such as 21 CFR Part 11, ANNEX 11, GxP, and GDPR, ensuring global compliance. PvEdge utilizes advanced automation powered by AI and machine learning algorithms to enhance efficiency in drug safety database management. Key features include automated literature monitoring, ICSR submissions, smart triage, automated signal detection, and document automation. The platform also provides a controlled document management system for creating, managing, and publishing pharmacovigilance documents, as well as a risk-based enterprise quality management system to implement quality processes and training records.
Learn more
biologit MLM-AI
Biologit offers a comprehensive suite of software and services designed to enhance safety surveillance across various industries. Their flagship product, biologit MLM-AI, is an all-inclusive global and local medical literature monitoring platform powered by AI. This scientific literature monitoring platform is simple to use, fully web-enabled, and validated for compliance, providing productivity gains for human and veterinary pharmacovigilance. Key features include integrated search and configurable literature screening workflows delivering up to 70% productivity gains powered by AI, a flexible and validated SaaS platform that is GxP-ready and CFR-11 compliant, and a database hosting major global and local literature sources with automatic article de-duplication. In addition to its software solutions, Biologit offers consultancy services covering pharmacovigilance, veterinary pharmacovigilance, and more.
Learn more
CoVigilAI
CoVigilAI is an AI-enabled medical literature monitoring solution that employs advanced algorithms and data analytics to proactively detect and manage adverse drug events, ensuring patient safety and regulatory compliance in real time. The platform offers streamlined tracking of scientific and medical publications across prominent global literature databases such as PubMed and Embase, with customizable search strings facilitating an effortless pharmacovigilance literature monitoring journey. Periodic surveillance of scientific and medical literature databases and publications from diverse local journals is conducted, encompassing both global literature monitoring and localized literature surveillance. Advanced algorithms categorize Individual Case Safety Reports (ICSRs) into valid, potential, and invalid cases, while automated key entity detection efficiently recognizes crucial entities like patients, medications, adverse events, and designated medical events.
Learn more
Compier Literature Screening
Compier Literature Screening is an AI-driven platform designed to assist pharmacovigilance professionals in efficiently screening abstracts, full texts, and translated articles to identify patients, authors, events, products, and safety-related information. The platform offers built-in integration with online biomedical databases such as Medline and supports bulk uploading of literature records from sources like Embase, conference presentations, and PDF journals. It performs automated duplicate checks for each literature search and utilizes validated AI models for automatic screening and annotation of entities. Users can configure scalable literature screening workflows tailored to specific requirements and global regulations. The system facilitates communication with third-party vendors to obtain full texts and includes built-in translation capabilities. It also integrates with safety systems, such as Oracle Argus Safety, to transmit ICSR-relevant articles.
Learn more
Integrations
No integrations listed.
Company Information
Quanticate
Founded: 1994
United Kingdom
www.quanticate.com/pharmacovigilance-safety-database
Videos and Screen Captures
Other Useful Business Software
Ship Agents Faster
Gemini Enterprise Agent Platform lets you rapidly build, scale, govern and optimize production-ready agents grounded in your organization's data. The platform enables developers to build custom or pre-built agents for virtually any use case. New customers get $300 in free credits.
Product Details
Platforms Supported
Cloud
Training
Documentation
Live Online
Webinars
In Person
Videos
Support
Phone Support
Online
