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.
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cubeSAFETY
cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead.
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Veeva Vault Safety
Veeva Vault Safety is a modern individual case safety report management system that supports the intake, processing, and submission of adverse events for clinical and post-marketed products. Within one system, sponsors and CROs can process global and domestic adverse events for drugs, biologics, vaccines, devices, and combination products. Built-in gateway connections and reporting rules streamline the submission management of cases to health authorities and distribution to partners. Central coding dictionary management automates semi-annual MedDRA, WHODrug, and EDQM updates. Vault Safety unifies pharmacovigilance systems and processes on a single cloud platform to deliver proactive patient safety. It leverages real-time reports and dashboards and seamless collaboration to provide visibility and compliance for adverse events.
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Clienvo eTMF
Clinevo electronic Trial Master File (eTMF) is an easy-to-use electronic Trial Master File in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials. Clinevo electronic Trial Master File (eTMF) has an inbuilt DIA reference model and meets regulatory guidelines. Clinevo MICC Intake is a web-based tool for Medical Information Call Center (MICC) and PV users to Log, Track and Monitor Product Quality Complaints (PQCs), Medical inquiries (MIs) and Adverse Events (AEs). Clinevo Safety is a cloud-based, user-friendly, easy-to-use, regulatory-compliant end-to-end Pharmacovigilance / Drug safety system. The All-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety signals capabilities under one platform. Clinevo Website Intake is a web-based tool which can be connected to Sponsor / CRO websites to provide Consumers and Reporters a User friendly web interface.
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