Best Pharmacovigilance Software
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Compare the Top Pharmacovigilance Software as of October 2025
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What is Pharmacovigilance Software?
Pharmacovigilance software is software to enhance drug safety by automating the detection, monitoring, and management of adverse drug reactions (ADRs). It streamlines processes such as case intake, signal detection, compliance reporting, and risk assessment, ensuring regulatory adherence across global markets. By leveraging advanced technologies like artificial intelligence and data analytics, it processes large datasets from sources like clinical trials and patient feedback to identify potential safety concerns. The software enables pharmaceutical companies and healthcare organizations to improve operational efficiency while maintaining high safety standards. Ultimately, it plays a critical role in protecting patient health and ensuring the safety of pharmaceutical products. Compare and read user reviews of the best Pharmacovigilance software currently available using the table below. This list is updated regularly.
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Flex Databases
Flex Databases
Document management and ensures regulatory compliance in clinical trials. By integrating AI and a unique "co-pilot" feature, our platform boosts efficiency while maintaining human oversight. Automated Filing with AI The AI assistant automates document classification and metadata assignment, reducing manual effort. Co-Pilot for Human Control The "co-pilot" feature allows users to set confidence levels for AI classification. Documents below the threshold are flagged for review, and users can adjust classifications, helping the AI improve. Key Benefits: Efficiency: AI automates tasks, allowing more focus on critical activities. Accuracy: AI and co-pilot oversight ensure data integrity and compliance. User-Friendly: An intuitive interface simplifies document management. Continuous Learning: AI improves accuracy with ongoing user feedback.Starting Price: $1300.00 -
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DF mSafety AI
Datafoundry
DF mSafety AI is a cloud-based safety platform that leverages AI/ML and automation to enhance efficiency and user experience in safety case management and signal detection for drugs, cosmetics, vaccines, nutraceuticals, and medical devices. Built on Datafoundry's loud platform, DF Safety 4.0, it supports scalable and secure AI/ML-driven safety case and signal management, with pre-built connectors to enterprise systems, adhering to regulatory requirements and industry standards. Key features include multi-source case intake options, automated triage rule configuration, seriousness prediction, causality assessment, expectedness and listedness assessment, auto narrative generation, custom report generation, literature monitoring for safety, signal and risk management, case compliance alerts, integrated MedDRA and WHO-DD browsers, enhanced E2B R2 & R3 compliance, and an e-submissions gateway. -
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Clienvo eTMF
Clinevo
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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TrackWise
Honeywell International
Honeywell's TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to help organizations efficiently manage quality and compliance processes. Leveraging nearly three decades of industry experience, it offers integrated modules that support various quality management aspects, including document control, training management, and corrective and preventive actions (CAPA). The platform incorporates advanced digital technologies such as artificial intelligence and machine learning to provide actionable, real-time insights, enabling proactive quality management. Its flexible, modular architecture allows for seamless integration with existing enterprise systems, facilitating rapid deployment and scalability. By streamlining quality processes and ensuring compliance with industry standards, TrackWise Digital® empowers organizations to bring products to market faster while minimizing risk.Starting Price: $200 per month -
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Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development. Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance.
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K2C PSMF Solution is a modern approach to the management of the Pharmacovigilance System Master File. This document typically requires periodic updates as per significant changes in the pharmacovigilance process. These changes require that multiple company roles are involved in editing a document that is composed of paragraphs and annexes that are all the time same because fixed by regulations. However co-editing is complex; in addition, part of the content should be reserved to some editors and even not available to other contributors. K2C solution allows handling the distinct paragraphs and annexes as single documents, then it offers the possibility to create the PSMF document as a merge of various source documents. K2C PSMF Solution includes management of PSMF contributions (paragraphs and annexes) as distinct documents; management of access rights for viewing or editing of PSMF contributions; and management of the entire lifecycle.Starting Price: €8,500 one-time payment
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OpenSourcePV
OpenSourcePV
OpenSourcePV is a company founded by Lionel Van Holle in 2019 with the ambition to make use of free & open source technologies to raise the standards of pharmacovigilance and provide an affordable & competitive alternative to expensive software specialized in pharmacovigilance. To meet their regulatory obligations, pharma companies need to monitor the safety of their products. When they start to have a strong pipeline and multiple products on the market, the amount of data to be reviewed is soon too large to be reviewed manually. To benefit from quantitative analysis, they currently have two options: either they use an expensive suite of tools or they try to build something on their own. With OpenSourcePV, we accompany their journey in quantitative signal detection allowing them to benefit from pre-built modules and building something customized to their specific needs and data sources.Starting Price: Free -
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NewTn-SAFETY
NewTn-SAFETY
NewTn's SAFETY is an advanced pharmacovigilance cloud platform designed to accelerate safety processes and simplify compliance for pharmaceutical companies, startups, and contract research organizations. The system offers a comprehensive suite of features, including cloud-based scalability for superior data storage and processing capabilities, data reusability to eliminate redundant entries, real-time alerts and monitoring for prompt adverse reaction detection, and robust reporting functions that facilitate the generation of DSUR and PBRER reports. Tailored use cases highlight its benefits in establishing pharmaceutical safety databases for startups, providing cost-effective safety systems for budget-sensitive CROs, enhancing regulatory compliance for small and medium-sized pharmaceutical companies, and delivering comprehensive safety data analysis and reporting. The platform's intuitive UI/UX and support for DSUR/PBRER reporting make it a customized solution. -
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Qualio
Qualio
Qualio is an all-in-one quality and compliance management platform built for small and growing businesses in life sciences and healthcare. Reliable, affordable, and easy to use, Qualio helps companies building life saving products get to market faster by reaching 100% ISO, GxP, and FDA compliance. With Qualio, companies can conveniently manage document control, training, CAPAs, NCRs, audits, suppliers, complaints, and more in one platform. -
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Saama
Saama
Actionable insights, driven by the industry's #1 AI-powered clinical analytics platform, enable your teams to manage risk and improve performance across studies, systems, sites, and vendors. State-of-the-art clintech from Saama is designed to streamline your workflows, automate time-consuming processes, and improve collaboration across clinical operations, medical review, data management, biostatistics, and pharmacovigilance. Sponsors and CROs rely on Saama for data aggregation and artificial intelligence solutions that lead to better decision-making, eliminate delays, and significantly shrink drug development costs and timelines. Saama can put you on the fast track to clinical trial process innovation. When all your clinical data is in one place and updated in real time, life’s much easier for your ClinOps and medical review teams. Data Managers have been underappreciated for too long. Eliminate manual work so they can pay attention to the data points that matter. -
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Embase
Elsevier
Improve your biomedical research with the world’s most comprehensive biomedical literature database. More biomedical evidence by searching comprehensive, relevant, and up-to-date biomedical research. Create systematic searches and automate query building using intuitive search forms. Uncover drug-disease relationships and drug-drug interactions, manually curated from deep indexing. The accelerated pace of biomedical research and development demands comprehensive information. You anticipate risk by assessing everything that is known. You track safety to meet regulations. You uncover connections to push innovations. Embase is a unique medical literature database where comprehensive goes beyond content. With Emtree indexing of full-text content and dedicated search terms, you find all relevant and current results. This includes information that may not be uncovered in other databases. Scroll down to find out why regulatory agencies recommend Embase in their best practice guidelines. -
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InfoDesk
InfoDesk
Aggregate, enrich and monitor key information sources at scale with unparalleled integrations across premium licensed content, the open web, and internal intelligence sources. Identify the signal and eliminate the noise with the power of InfoDesk's information lab. Having supported global analysis teams for the past 25 years, we build powerful tools to make your lives easier. By leveraging our proven intelligence workflow, enhanced by enterprise-grade analysis tools, our solution streamlines monitoring and analysis, allowing professionals to focus on high-impact initiatives across regulatory, pharmacovigilance, competitive, market, and strategic intelligence functions. Centralize key information, streamline analysis, and empower stakeholders with trusted intelligence, powered by enterprise-grade AI. Get trusted intelligence into the hands of your stakeholders with our industry-leading deliverable engine. Drive engagement like never before with dynamic dashboards. -
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Tepsivo
Tepsivo
Tepsivo's pharmacovigilance software solutions are designed to streamline drug safety processes through automation and smart templates, significantly reducing administrative burdens and associated costs. The Tepsivo Platform is a comprehensive, cloud-based application that allows users to manage all pharmacovigilance activities in one centralized location. Key features include a Quality Management System, Local Contact Person for Pharmacovigilance (LCPPV) oversight, streamlined safety reporting and follow-up tools, PSUR tracking, signal management tracking, automated audit trails, compliance tracking, adverse event intake tools, literature monitoring, risk management system tracking, PSMF management solutions, automated partner reconciliation, and CAPA management. These integrated modules ensure full transparency, 100% compliance, inspection readiness, high quality, rapid speed, no administrative overhead, and minimal cost. -
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Oracle Life Sciences Empirica is the market-leading solution for detecting, analyzing, and managing safety signals originating in pre- and post-market drugs, biologics, vaccines, devices, and combination products. Oracle continually researches, develops, and advances the state-of-the-art data-mining algorithms and statistical techniques used in Empirica. By enabling the detection of signals with a longer lead time, Empirica can provide risk insights 7 to 22 months earlier than labeling revision dates from a time-indexed benchmark. Safety teams responsible for signal management face new challenges, such as finding hidden signals, assessing information from multiple big data sets, and providing better safety information before clinical trials even begin. Read our ebook to learn how new advances in methodologies and technologies, such as artificial intelligence, can help address these challenges.
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Oracle Argus
Oracle
The market-leading, trusted solution for processing, analyzing, and reporting adverse event cases originating in premarket and post-market drugs, biologics, vaccines, devices, and combination products. Transform your case management efficiency with innovative capabilities, such as built-in automation, workflow optimization, and conditional touchless processing. You can depend on Argus, a mature, reliable solution providing proven compliance with drug, vaccine, and device regulations and standards in all regions of the world, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP. Argus Advanced Cloud includes Oracle Analytics, a powerful, flexible, AI-powered solution that empowers users to uncover new insights and make faster, more informed business decisions. Medicinal product safety teams face enormous pressure to control ever-increasing caseloads, new sources of signal detection data, and changing regulations, all with flat budgets and resources. -
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SafetyEasy
EXTEDO
EXTEDO's SafetyEasy is a comprehensive pharmacovigilance and multivigilance management software designed to streamline the processing of safety cases and vigilance data. It ensures compliance with various drug safety regulations, including E2B(R3) and HL7 eMDR, and supports the generation of essential regulatory documentation such as PSUR, PBRER, and DSUR. The platform offers features like workflow optimization through email notifications and online dashboards, enabling users to track project statuses and meet submission deadlines efficiently. SafetyEasy also incorporates advanced modules like CasEasy AI, which utilizes Natural Language Processing to automate case creation and a Business Intelligence module that provides a dynamic 360° view of scientific data to enhance case analysis and safety signal detection. As a cloud-based service, SafetyEasy™ is quick to implement, user-friendly, and requires minimal training. -
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Quanticate
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. -
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Drug Safety Triager
Clarivate
Drug Safety Triager is Clarivate's next-generation pharmacovigilance software designed to assist life sciences organizations in meeting regulatory requirements. This GxP-validated, compliant, and audit-ready system manages and streamlines the literature review workflow, enabling pharmacovigilance experts to focus on patient safety by simplifying literature review processes. The platform is fully validated and compliant with the reporting requirements of global safety regulatory agencies such as the FDA and EMA. Each implementation of the Drug Safety Triager is delivered with a validation package. The validation process and associated documentation align with the pharmaceutical industry and health authority regulations. All literature references undergo a systematic review process that automatically captures all users’ actions and adds a permanent, non-editable audit trail to the record. -
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Ennov's Pharmacovigilance Suite is an end-to-end solution for collecting, managing, assessing, and reporting human and veterinary adverse events within a unified database. The suite offers advanced signal detection and data analysis tools, ensuring compliance with global regulatory requirements. Key features include efficient case intake and triage with optimized user interfaces for data entry, flexible case input forms, and searchable vocabulary lists. The system supports both paper and electronic reporting formats, including CIOMS, MedWatch 3500s, and ICH E2B standards (R2 and R3 formats). For signal detection and management, it provides comprehensive data querying, powerful analysis capabilities, and the calculation of key statistical measures such as PRR, ROR, and MGPS. The platform is 100% web-based, user-friendly, and designed to comply with 21 CFR Part 11, ensuring data integrity and security.
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AccelSafety
Techsol Life Sciences
AccelSafety is a comprehensive pharmacovigilance platform developed by Techsol Life Sciences, built around the Oracle Argus Safety application to address the unified collection, medical assessment, and regulatory reporting of clinical and post-marketing safety surveillance data. The fully managed cloud solution facilitates emerging biopharma companies, device manufacturers, and service providers in managing safety data and making informed business decisions in alignment with global compliance requirements. Key benefits include fast-track Argus Safety implementation, migration, and validation with a 70% effort reduction; secure migration of legacy safety data to the AccelSafety Cloud; simplified lean case processing through customized configurations and native automation; comprehensive operational insights via advanced reports, line listings, and analytics packages; and 24/7 Argus Safety Service Desk support for user requests, incidents, and change management. -
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biologit MLM-AI
biologit
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. -
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PVSEARCH
PVSEARCH
PVSEARCH is a validated data management system developed by Owlpharma Consulting Lda. for pharmacovigilance professionals. As a software as a service (SaaS), it supports medical literature screening activities by functioning as a scientific literature repository connected to a robust, configurable search engine. Users can create queries using predefined inputs and Boolean operators, allowing for systematic and automated searches within the database. The platform accommodates various written variants of substances, including non-standard ones, by enabling clients to include custom-created terms alongside common terms available in the system database. PVSEARCH's database encompasses a comprehensive collection of relevant local publications, such as journals, websites, newsletters, and congress publications covering human and veterinary health in Portugal. Clients can select specific publications for inclusion in their periodic searches. -
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PharmaPendium
Elsevier
PharmaPendium is a comprehensive resource that provides access to FDA and EMA drug approval documents, including pharmacokinetic, pharmacodynamic, and safety profiles. It offers detailed information on drug-drug interactions, adverse effects, and clinical study outcomes, facilitating informed decision-making in drug development and regulatory submissions. The platform's extensive data supports researchers and healthcare professionals in evaluating drug efficacy and safety, contributing to the advancement of pharmaceutical research and patient care. Find information about previous regulatory submissions and profit from precedents to predict agencies’ requirements. Seamlessly move from table view to interactive charts, graphs, and visual aids to easily interrogate and interpret data. Find information by adverse events (MedDRA), targets, indications, drug,s and endpoints using normalized data. Result pages bridge the preclinical to clinical divide. -
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IQVIA Vigilance Platform
IQVIA
IQVIA Vigilance Platform is an integrated, comprehensive platform built to simplify safety and pharmacovigilance processes while boosting speed, accuracy, and efficiency. Delivered in our secure SaaS environment, using proprietary artificial intelligence, machine learning, and natural language processing algorithms, Vigilance Platform delivers insights that improve compliance, and product safety, and add value to your product development process. The platform covers every aspect of pharmacovigilance processes, capturing cases from patients through case processing, case submission to all authorities, and all case types. An intuitive interface makes IQVIA Vigilance Platform easy to use for affiliates, case processing teams, and signal detection teams. A transformational approach to pharmacovigilance improves compliance so you can focus on delivering safer, more effective drugs and devices faster. -
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PvEdge
Sarjen Systems
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. -
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Orbit
Orbit
Orbit is a strategic platform designed to enhance patient safety by assisting small, medium, and large biopharma companies in scaling their safety operations across global markets. It offers innovative solutions for global pharmacovigilance, safety, and risk management oversight, aiming to increase global quality, demonstrate compliance, improve productivity and efficiency, and provide meaningful oversight of traditionally complex and siloed processes. Key features include risk management and minimization, which tracks global risk management plan commitments and supports local additional risk minimization measure implementation; safety data exchange and pharmacovigilance agreements management, allowing oversight across global partnerships; signal and surveillance management, covering signal management from strategy through detection activities, signal assessment, and tracking. -
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TARA PV
MedGenesis
TARA PV is a comprehensive, web-based pharmacovigilance safety database designed for processing, storing, analyzing, and reporting adverse events related to drugs, devices, and vaccines. Developed by MedGenesis Ltd, an ISO 9001 and ISO 27001 accredited UK-based software development company, TARA PV offers a user-friendly interface that is simple, intuitive, and fully compliant with 21 CFR Part 11, GxP, ICH standards, and global pharmacovigilance data protection regulations. As a cloud-based solution, TARA PV requires no installation and is accessible via an internet browser, enabling rapid implementation and integrated workflows for individual case assignments. The system provides full training upon deployment, with ongoing support available through an online ticketing system. Security is a priority, with hosting that features multiple redundancies and triple-layer backups. TARA PV offers a range of transparent pricing models with no hidden costs. -
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Bibliovigilance
Bibliovigilance
Bibliovigilance is a search platform for pharmacovigilance literature that aims to streamline the process of monitoring scientific and medical publications for safety information. It offers a comprehensive database of significant national scientific publications across Europe and beyond, covering both human and veterinary products. The platform enables users to perform global searches by running queries in PubMed and accessing PRAC safety recommendations on signals, centralizing all literature searches in one location. Users can save their search queries, schedule automatic searches, and choose to search only for new articles since the last query, thereby saving time and reducing repetitive tasks. All searches are stored in a personal area, allowing users to see and document their search history at any time. The database is constantly updated, providing information on publications, the latest update dates, and the number of indexed articles, ensuring transparency in content. -
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PubHive Navigator
PubHive
PubHive Navigator is an AI-powered software platform that streamlines scientific literature and safety workflows for life science companies of all sizes. It offers centralized end-to-end workflow solutions for literature review, curation, annotation, collaboration, searching, reporting, citing, and managing research. The platform features AI-powered smart workspaces for centralized literature management, collaborative research writing and team communication, reuse rights and document delivery integrations, and out-of-the-box workflows for different operation units. PubHive Navigator is designed to simplify enterprise scientific literature and safety information workflows, making it a flexible software platform for teams in drug safety and pharmacovigilance, medical affairs, clinical affairs, and R&D. -
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TrominoCARE
TrominoSoft
TrominoCARE is a scalable, cloud-based Medical Information Call Center (MICC) software designed to automate daily operations within medical information call centers. It features a comprehensive database that supports the entire lifecycle management of MICC activities, handling various call types such as medical inquiries, product quality complaints, and adverse events. Accessible via mobile phones, tablets, and desktops, TrominoCARE ensures flexibility and responsiveness across devices. Key capabilities include process automation for managing all call types, automatic generation of Field Alert Reports (FARs), a configurable client product dictionary, and customizable workflows tailored to specific business needs. The platform also offers a mobile application enabling medical sales representatives and field teams to capture and report information offline, with integration capabilities for safety and MICC systems.