List of the Top Pharmacovigilance Software in 2025 - Page 2

Orbit serves as an all-encompassing platform focused on enhancing patient safety by assisting biopharma companies, regardless of their size, in broadening their safety operations across global markets. This innovative platform delivers state-of-the-art solutions for international pharmacovigilance, safety management, and risk supervision, with aims to improve overall quality, guarantee compliance, increase productivity and efficiency, and provide robust oversight of often intricate and segmented processes. Key functionalities include risk management and reduction, which aid in tracking commitments outlined in global risk management plans while promoting the application of local risk mitigation strategies; management of safety data exchanges and pharmacovigilance agreements, which allows for effective supervision of global partnerships; as well as signal and surveillance management that covers a wide range of activities, from strategic planning to detection, signal assessment, and continuous monitoring. Furthermore, the intuitive design of Orbit’s interface ensures that teams can effortlessly navigate the platform, maximizing the use of its diverse features. As such, this platform not only streamlines operations but also fosters a culture of safety and compliance across the biopharma industry.

TARA PV serves as a robust online pharmacovigilance safety database meticulously designed for the efficient management of adverse event processing, storage, analysis, and reporting linked to pharmaceuticals, medical devices, and vaccines. Developed by MedGenesis Ltd, a software company based in the UK and recognized for its ISO 9001 and ISO 27001 certifications, TARA PV features an intuitive interface that complies with essential regulations, including 21 CFR Part 11, GxP, ICH standards, and various international pharmacovigilance data protection laws. As a cloud-based solution, it requires no installation, enabling users to access the platform through any web browser, which promotes quick implementation and smooth workflows for handling individual case assignments. Once implemented, users benefit from thorough training sessions, along with ongoing assistance through an online ticketing system to resolve any potential issues. With a strong emphasis on security, TARA PV is hosted with multiple layers of redundancy and triple backups to safeguard data integrity. Users will find a range of transparent pricing options without hidden charges, making it an appealing choice for organizations seeking clarity in costs. Moreover, TARA PV is designed to evolve alongside regulatory changes, ensuring that users remain compliant and well-supported in the future. The platform’s adaptability further enhances its value in a rapidly changing healthcare environment.

PubHive Navigator represents a cutting-edge software solution that leverages artificial intelligence to improve the effectiveness of scientific literature management and safety protocols for life science entities of all sizes. It offers a robust array of workflow tools that include literature review, curation, annotation, collaborative efforts, search capabilities, reporting, citation management, and oversight of research activities. The platform features AI-enhanced smart workspaces that enable centralized literature management, collaborative writing for research initiatives, and efficient team communication, all while providing integrations for document delivery and reuse rights, along with pre-configured workflows designed for various operational sectors. Additionally, PubHive Navigator seeks to simplify the intricate challenges tied to enterprise-level scientific literature and safety information processing, making it a flexible resource for teams involved in areas such as drug safety and pharmacovigilance, medical affairs, clinical affairs, and research and development. This adaptability not only streamlines operation but also empowers organizations to refine their research workflows and boost productivity across their teams, fostering a more dynamic approach to scientific advancement. Ultimately, the platform's design supports continuous improvement and innovation in life sciences.

TrominoCARE is an innovative, cloud-based software designed for Medical Information Call Centers (MICC), aimed at optimizing the everyday functions of these centers. It features a comprehensive database that supports the management of MICC operations throughout their entire lifecycle and caters to various call types, including medical inquiries, product quality concerns, and adverse event reporting. Accessible on mobile devices, tablets, and desktops, TrominoCARE enhances flexibility and enables rapid responses across multiple platforms. Key functionalities include the automation of processes for different call types, automatic generation of Field Alert Reports (FARs), and a customizable product dictionary alongside personalized workflows tailored to meet unique business needs. Furthermore, the platform offers a mobile application that allows medical sales representatives and field teams to gather and relay information even when offline, while ensuring smooth integration with safety protocols and MICC systems. This all-encompassing strategy significantly improves efficiency and fosters better communication within the medical information sphere, ultimately leading to improved service delivery and a more responsive healthcare environment.

Sentria stands out as an innovative platform that leverages artificial intelligence to oversee adverse event cases and facilitate post-marketing surveillance. This sophisticated software is not only user-friendly and highly customizable but also automated, ensuring compliance with industry regulations while enhancing the efficiency, speed, and accuracy of adverse event management. It effectively supports pharmacovigilance adherence to international ICH guidelines, along with local regulatory standards for adverse event evaluation. By offering an intuitive interface powered by pharmacovigilance automation, Sentria reduces reporting mistakes through intelligent alerts and streamlines the report processing by incorporating global coding standards such as MedDRA and ATC/WHO. Additionally, the platform significantly boosts analytical capabilities by implementing semantic artificial intelligence specifically designed for pharmacovigilance requirements. Among its key features are secure access regulated by user credentials, detailed auditable logs for compliance tracking, and a secure, encrypted cloud environment to safeguard data. Collectively, these features equip organizations with the tools to manage adverse events more efficiently, ultimately leading to improved patient safety outcomes. Moreover, Sentria's commitment to continuous improvement ensures that it remains at the forefront of pharmacovigilance technology, adapting to the evolving needs of the healthcare industry.

DrugCard is an innovative data intelligence platform that utilizes artificial intelligence to significantly improve pharmacovigilance efficiency through the automation of local literature screening. With support for over 100 languages, it continuously tracks more than 1,000 medical journals across 55 countries, providing comprehensive, ongoing, and transparent monitoring. By taking over repetitive tasks, DrugCard enables Contract Research Organizations (CROs) to manage more pharmacovigilance projects while enhancing the quality of their results. Furthermore, Marketing Authorization Holders (MAHs) can conduct in-house literature reviews with increased efficiency, allowing freelancers to save up to 70% of their time, which can be redirected to more strategic initiatives. The platform is designed to be flexible for new markets, cost-effective, and compliant with regulatory demands, making it an ideal choice for drug safety departments. Its cutting-edge features not only streamline workflows but also empower organizations to focus on safety and regulatory adherence. Ultimately, DrugCard represents a transformative approach to drug safety, enhancing both operational effectiveness and compliance standards.

LifeSphere Safety introduces an advanced, comprehensive SaaS Safety platform that streamlines case management, boosts compliance capabilities, and unifies pharmacovigilance practices on a global scale. Initiate transformative changes with its exceptional features, which integrate the latest innovations in automation, analytics, and GenAI technologies, all powered by LifeSphere NavaX. Experience substantial improvements in efficiency through automated case processing that leverages robust, production-ready AI to refine everyday safety tasks. Benefit from unparalleled turnkey support for both international and local regulations, which allows you to confidently operate in any market while enjoying continuous cloud enhancements that ensure persistent compliance. Elevate safety from a mere obligation to a strategic advantage by utilizing effective, user-friendly tools for reporting, building dashboards, benchmarking operations, and conducting insightful signal analysis, thereby keeping your organization aligned with the highest industry standards. Step into the future of safety management with LifeSphere Safety's revolutionary solutions, meticulously crafted to adapt to the changing requirements of the regulatory environment, ensuring your organization is always prepared for what lies ahead. By harnessing these innovative tools, you can foster a culture of safety that not only meets but exceeds regulatory expectations.

Veeva Vault Safety is a sophisticated system engineered for the oversight of individual case safety reports, streamlining the collection, management, and reporting of adverse events associated with both clinical studies and marketed products. This all-encompassing platform empowers sponsors and contract research organizations (CROs) to efficiently address both global and local adverse events across a range of categories, such as pharmaceuticals, biologics, vaccines, medical devices, and combination products. With its integrated gateway connections and established reporting protocols, the system significantly boosts the efficiency of case submissions to regulatory bodies and facilitates the sharing of pertinent information with various partners. Moreover, the centralized management of coding dictionaries ensures that updates for MedDRA, WHODrug, and EDQM occur semi-annually, thereby maintaining accuracy and compliance. By unifying pharmacovigilance processes within a single cloud-based environment, Vault Safety champions proactive initiatives aimed at enhancing patient safety. The inclusion of real-time reports and dashboards, along with enhanced collaborative features, further improves visibility and adherence to adverse event reporting standards. In conclusion, this groundbreaking solution not only redefines safety management practices within the pharmaceutical sector but also enables a more agile and comprehensive approach to addressing patient safety issues effectively. As a result, it helps organizations stay ahead of regulatory demands while prioritizing the well-being of patients.

The Thrana Safety Database is a cloud-based platform designed specifically for pharmacovigilance and the management of drug safety. With a strong emphasis on user experience, this all-encompassing solution seamlessly integrates key functionalities such as PV Intake, Case Processing, Regulatory Submissions through AS2 Gateways, Regulatory Reports, and Analytics, all accessible from a single, cohesive interface. Such an integrated approach not only boosts efficiency but also simplifies workflows for users throughout the pharmaceutical sector. Additionally, it supports compliance with regulatory standards, ensuring that safety data management is both effective and reliable.

Axiom has developed Fusion, a unique and affordable eClinical platform designed specifically for small to medium-sized companies in the device, pharmaceutical, and biotech sectors. This comprehensive eClinical Suite offers customizable Modules tailored to your study’s specific requirements. If you are conducting a smaller study, you can select a foundational setup that includes Electronic Data Capture (EDC) and Data Management (DM), along with Adverse Event (AE) and Serious Adverse Event (SAE) tracking. For those seeking enhanced functionalities, Fusion provides advanced Modules such as Inventory Tracking, Randomization and Trial Supply Management (RTSM), and Safety Management to streamline study oversight. The platform also facilitates the electronic collection of study data, even in offline scenarios, ensuring that once an internet connection is available, your information seamlessly syncs with the Fusion databases. This capability enables real-time access to records relevant to subject screening activities, while the Fusion Safety Database effectively supports the management of pharmacovigilance events for improved patient safety. Overall, Fusion stands out as a versatile solution to meet diverse clinical trial needs.

Efficiently monitoring a variety of data sources, in conjunction with a GVP IX compliant signal management system, can significantly enhance the way safety data is processed. The Evidex platform provides a comprehensive, ready-to-use solution that adheres to GVP-IX standards, allowing for smoother operations without the need to navigate through multiple services. By updating your management workflows, you can create processes that are both efficient and resistant to audits. This level of automation aids in fulfilling regulatory requirements while simultaneously increasing the overall benefits for your organization. Through the use of automated signal detection, safety signals can be recognized from key resources, such as ICSR databases and the FDA's Adverse Event Reporting System (FAERS), alongside VigiBase and clinical trial information. Additionally, you can enhance your data landscape by adding other sources like claims, electronic health records (EHR), and various forms of unstructured data. By combining these different data sources, you can enhance signaling algorithms, streamline validation processes, and respond more swiftly to urgent drug safety issues. Furthermore, this innovative approach redefines how organizations handle and utilize safety data, ultimately leading to improved results and a more proactive stance on drug safety management.

SlimEDC offers a cloud-based platform specifically tailored for Electronic Data Collection (EDC), facilitating the efficient launch of both retrospective and prospective studies, which encompass patient studies (ePRO) and market research initiatives, all through an intuitive study editor. Users have the option to select a fully managed software service supervised by the research sponsor or a more hands-on approach where a dedicated SlimEDC team oversees the entire project, leading up to data analysis. Designed with adherence to EU regulations and standards in mind, SlimEDC actively engages respondents electronically while the platform automatically produces all requisite reports as required by regulatory agencies. Moreover, SlimEDC upholds ISO 9001 and 27001 certifications, underscoring its unwavering dedication to quality and security. Our team is not only certified by BHBIA but has also undergone specialized pharmacovigilance training to further bolster our proficiency. In addition, rigorous GDPR audits performed by independent organizations ensure that our legal and data security protocols adhere to the highest standards, safeguarding sensitive information throughout the research journey. By emphasizing both regulatory compliance and an exceptional user experience, SlimEDC establishes itself as a trusted ally in the field of electronic data collection, ultimately enhancing the quality and integrity of research outcomes. This commitment to excellence positions SlimEDC as a leader in innovation and reliability within the industry.

DF mSignal serves as a flexible and scalable system for the management of safety signals, significantly improving the effectiveness of risk management and signal detection within the pharmaceutical and medical device sectors, while also encompassing areas such as cosmetics and nutraceuticals. The platform offers both active and passive monitoring, featuring real-time monitoring of product-event combinations along with customizable clinical risk indicators and a user-friendly interface enriched by advanced analytics. It effortlessly integrates with MedDRA, WHO DD, clinicaltrial.gov, and various electronic data collection systems, delivering a holistic safety solution for industry professionals. Additionally, DF mSignal AI employs automation to calculate statistical scores, streamlining the signal detection process and enhancing accuracy. The system is meticulously designed to adhere to all relevant regulations, including 21 CFR Part 11, and incorporates stringent data privacy and integrity controls, as well as Good Practice guidelines (GxPs), to guarantee compliance and security for users. With its comprehensive features, DF mSignal not only optimizes safety signal management but also fosters confidence among stakeholders in the regulatory landscape.

Clinevo Safety is an all-inclusive, cloud-based solution for pharmacovigilance and drug safety that boasts user-friendliness and adherence to regulatory requirements. This versatile platform encompasses a range of functionalities such as PV intake, case processing, regulatory submissions via an AS2 gateway, as well as analytics and safety signal detection. With a straightforward technological infrastructure, it offers extensive configuration options while minimizing the need for customizations, leading to lower overall ownership costs and easy maintenance. Users are notified of cases nearing their deadlines, helping them stay compliant efficiently. The platform is equipped with advanced automation and AI features that significantly improve case processing speed, and its dynamic workflows can be easily tailored to ensure swift case management. Through its robust analytics, Clinevo Safety equips users with valuable insights that are both impactful and actionable. Being a web-based application, it allows access from any device at any time through popular browsers like Internet Explorer, Chrome, and Firefox, making it highly convenient for users who are frequently on the move. Additionally, its intuitive design emphasizes usability, allowing all users to navigate the system confidently and effortlessly while optimizing their workflow. This attention to user experience ultimately fosters a more effective approach to drug safety and compliance management.

AccelSafety, developed by Techsol Life Sciences, serves as a comprehensive pharmacovigilance solution that leverages the Oracle Argus Safety application to enhance the collection, medical assessment, and regulatory documentation of safety data from both clinical trials and post-marketing surveillance. Designed specifically for new biopharma firms, medical device producers, and service organizations, this fully managed cloud-based platform empowers users to efficiently manage safety data and make knowledgeable business choices while complying with international regulations. Its key benefits include a streamlined implementation process with a 70% reduction in effort for migrating and validating the Argus Safety system; secure migration of historical safety data into the AccelSafety Cloud; improved efficiency in case processing through customized configurations and automation capabilities; comprehensive operational insights through advanced reports, line listings, and analytics; and 24/7 assistance from the Argus Safety Service Desk for addressing user queries and managing incidents. Additionally, this platform guarantees that users can uphold high standards of accuracy in safety reporting and regulatory compliance throughout their operations, ultimately fostering a safer environment for patients. The combination of these features positions AccelSafety as a vital asset for organizations striving to enhance their pharmacovigilance processes effectively.

DF Literature Monitor is an innovative AI-powered platform designed to simplify the extensive task of literature monitoring and improve safety oversight protocols. It interfaces with essential local and global literature databases to gather articles simultaneously, employing advanced semantic search technology to effectively identify relevant research. The tool features automatic de-duplication, essential safety information extraction, and the ability to pre-fill safety case forms, which can be submitted to safety databases in E2B or Excel/PDF formats with just a single click. Additionally, it offers automated translation services for both abstracts and full articles into English, enhancing accessibility for diverse teams. DF Literature Monitor also boasts customizable workflows that foster collaboration and ensure rigorous quality control among pharmacovigilance professionals. By implementing this solution, organizations can potentially cut down on the time and resources dedicated to literature monitoring by 60% or more, all while upholding strict quality standards and regulatory compliance. This tool is a groundbreaking advancement in pharmacovigilance, enabling teams to concentrate on critical evaluation instead of tedious manual tasks, ultimately improving overall efficiency and effectiveness in safety monitoring.

Compier Literature Screening is an AI-driven tool designed to assist pharmacovigilance professionals in enhancing the efficiency of their review processes for abstracts, full texts, and translated documents to extract relevant details regarding patients, authors, events, products, and safety information. This cutting-edge platform integrates effortlessly with a range of online biomedical databases, such as Medline, and empowers users to upload large volumes of literature from diverse sources like Embase, conference proceedings, and PDF journals. It performs automated checks to eliminate duplicate entries for each literature search and utilizes validated AI technologies for the automatic identification and annotation of critical information. Users can customize scalable literature screening workflows tailored to their specific requirements while adhering to global regulatory standards. The system further fosters collaboration with external vendors to obtain full texts and is equipped with capabilities for translation. Additionally, it integrates seamlessly with safety management systems like Oracle Argus Safety, facilitating the sharing of articles pertinent to Individual Case Safety Reports (ICSRs) and thereby bolstering thorough safety monitoring. By streamlining these processes, the platform ultimately aims to enhance both the accuracy and effectiveness of pharmacovigilance operations, providing a valuable resource for professionals in the field. Furthermore, its user-friendly interface ensures that even those with minimal technical expertise can navigate the system efficiently.

Bibliovigilance functions as a dedicated search engine specifically tailored for pharmacovigilance literature, aimed at improving the effectiveness of monitoring scientific and medical publications for insights related to safety. It features a comprehensive collection of significant national scientific publications from Europe and various other locations, covering both human and veterinary products. Users can perform global searches by querying PubMed and examining PRAC safety recommendations regarding signals, which allows for the integration of all literature searches into one convenient platform. Moreover, the tool provides users with the ability to save their search efforts and set up automatic updates, with filters available to display only new articles published since their last inquiry, thereby enhancing workflow efficiency and reducing repetitive searches. Each search is stored in a personal area, allowing users to easily revisit and assess their search history as needed. The database undergoes regular updates, guaranteeing that users have access to the most current information on publications, recent revision dates, and a precise tally of indexed articles, which enhances transparency and trustworthiness in the content offered. In addition, the platform's intuitive features promote regular usage, making it an essential asset for experts in the pharmacovigilance domain. As a result, Bibliovigilance not only supports professionals in their research endeavors but also contributes to the overall improvement of drug safety monitoring practices.

CoVigilAI represents a state-of-the-art innovation in the realm of medical literature monitoring, harnessing the power of artificial intelligence and advanced data analytics to proactively detect and manage adverse drug reactions, ensuring patient safety and compliance with regulatory requirements in real-time. This platform facilitates the efficient tracking of scientific and medical literature by retrieving data from prominent global databases such as PubMed and Embase, and it offers customizable search options that improve the pharmacovigilance literature review process. Furthermore, it conducts thorough evaluations of scientific articles and publications from various regional journals, guaranteeing an extensive oversight of both global and localized literature. With the implementation of sophisticated algorithms, the system categorizes Individual Case Safety Reports (ICSRs) into three distinct classifications: valid, potential, and invalid cases, while its automated key entity recognition feature proficiently pinpoints critical components such as patients, medications, adverse reactions, and pertinent medical events. This comprehensive strategy not only streamlines the monitoring procedure but also considerably boosts the precision and efficiency of drug safety evaluations, contributing to a safer healthcare environment. Ultimately, CoVigilAI serves as an indispensable tool for enhancing drug safety and fostering informed decision-making in the medical field.