Best Pharmacovigilance Software in China

Biologit provides a comprehensive set of software and services to enhance safety surveillance in various industries. Their flagship product, the biologit MLM AI, is a global and local medical monitoring platform powered by AI. This scientific literature monitoring tool is easy to use, validated for compliance and fully web-enabled. It provides productivity gains for human and animal pharmacovigilance. The platform includes a configurable literature screening workflow that can deliver up to 70% productivity gains, powered by AI. It also has a flexible SaaS platform which is GxP compliant and CFR-11 compatible, as well as a database with major global and local sources of literature, with automatic article deduplication. Biologit also offers consulting services in pharmacovigilance and veterinary pharmacovigilance.

PVSEARCH, a validated database management system, was developed by Owlpharma Consulting Lda. For pharmacovigilance specialists. It is a SaaS that supports medical literature screening by acting as a scientific repository linked to a robust and configurable search engine. Users can create queries by using predefined inputs, Boolean operators and automate searches in the database. The platform allows clients to add custom-created terms along with common terms in the database. This allows for a wide range of written variations, including nonstandard substances. PVSEARCH’s database includes a comprehensive collection relevant local publications such as journals and websites, newsletters and congress publications that cover human and veterinary healthcare in Portugal. Clients can choose specific publications to include in their periodic searches.

DF Literature Monitor, an advanced AI-powered system, automates the monitoring of large amounts of literature to optimize safety vigilance. It integrates with global and local literature sources to retrieve articles simultaneously, using semantic search. The platform offers automatic de-duplication and extraction of minimum safety data, as well as auto-population for safety case forms. These can be submitted in E2B, Excel/PDF, or Excel/PDF format to safety databases with just a click. It also offers automatic translation of abstracts and complete articles into English. DF Literature Monitor features configurable workflows that facilitate collaboration and quality assurance among pharmacovigilance groups. This solution allows teams to save up 60% or more in time and effort during the literature monitoring process, while maintaining quality and compliance.

PharmaPendium provides access to FDA/EMA drug approval documents including pharmacokinetics, pharmacodynamics, and safety profiles. It provides detailed information on drug interactions, adverse reactions, and clinical study results, allowing for informed decisions in drug development and regulatory filings. The platform's extensive database helps researchers and healthcare professionals evaluate drug efficacy, safety and effectiveness. This contributes to the advancement of pharmaceutical and patient care. Find out about previous regulatory submissions, and use precedents to predict agency requirements. You can easily switch from table view to interactive charts and graphs and visual aids for easy data interpretation. Using normalized data, you can find information by adverse events (MedDRA), drug indications, targets, and endpoints. The result pages bridge the gap between preclinical and clinical research.

IQVIA Vigilance Platform, an integrated, comprehensive platform, is designed to simplify safety and pharmacovigilance while boosting speed and accuracy. Vigilance Platform is delivered in a secure SaaS environment using proprietary artificial intelligence, natural language processing, and machine learning algorithms. It delivers insights to improve compliance and product safety and add value to the product development process. The platform covers all aspects of pharmacovigilance, from capturing cases to case processing and submissions to all authorities. It also covers all types of cases. IQVIA Vigilance Platform is easy to use by affiliates, case-processing teams, and signal detection team due to its intuitive interface. A transformational approach improves compliance, so you can focus more on delivering safer and more effective drugs and medical devices.

PvEdge, a cloud-ready software for pharmacovigilance, is designed to provide end-toend compliant safety solutions. It can be used with drugs, devices and vaccines. It provides a comprehensive database for safety that manages pharmacovigilance intake and case processing, submissions AI & Analytics, and safety signals, all on one platform. The system is compliant with existing and future regulations such as 21 CFR Part 11 ANNEX 11 GxP and GDPR. PvEdge uses advanced automation powered by AI algorithms and machine learning algorithms in order to improve the efficiency of drug safety database management. The platform's key features include automated literature scanning, ICSR submissions and smart triage. The platform includes a controlled document system for creating, publishing, and managing pharmacovigilance documentation, as well a risk-based enterprise management system that implements quality processes and records.

Orbit is a platform that helps small, medium and large biopharmaceutical companies scale their safety operations to global markets. It offers innovative solutions to global pharmacovigilance and safety oversight, with the goal of increasing global quality, demonstrating compliance, improving productivity and efficiency, as well as providing meaningful oversight for traditionally complex and siloed process. The key features are risk management and minimization which tracks global risk plan commitments and supports the local implementation of additional risk minimization measures; safety data exchange management and pharmacovigilance agreement management allowing oversight across global partnership; signal and surveillance, which covers signal management from strategy to detection activities, signal assessments, and tracking.

TARA PV is an extensive web-based pharmacovigilance database that allows users to process, store, analyze, and report adverse events related with drugs, devices, or vaccines. TARA PV was developed by MedGenesis Ltd., an ISO 9001/ISO 27001 accredited UK software development company. It offers a user friendly interface that is intuitive and fully compliant to 21 CFR Part 11, GxP standards, ICH regulations, and global pharmacovigilance. TARA PV is a cloud-based software solution that does not require installation. It can be accessed via an internet browser. This allows for rapid implementation of integrated workflows and individual case assignments. The system comes with a full training package upon deployment. Support is available via an online ticketing system. Security is a top priority with hosting that includes multiple redundancies, triple-layer backups and other security features. TARA PV offers transparent pricing with no hidden fees.

Compier Literature Screening, an AI-driven platform, is designed to help pharmacovigilance practitioners efficiently screen abstracts, full-texts, and translated articles in order to identify patients, authors and safety-related data. The platform supports bulk uploading literature records from sources such as Embase, conference presentations and PDF journals. It also offers built-in integration to online biomedical databases like Medline. It performs automated duplication checks for every literature search, and uses validated AI models to automatically screen and annotate entities. Users can customize scalable literature screening workflows to meet specific requirements and global regulatory requirements. The system allows communication with third party vendors to obtain complete texts, and has built-in translation capability. It integrates with safety software, such as Oracle Argus Safety to transmit ICSR relevant articles.

Bibliovigilance, a search engine for pharmacovigilance publications, aims to streamline the monitoring of scientific and medical literature for safety information. It provides a comprehensive database that includes important national scientific publications from Europe and beyond. This database covers both human and veterinary product. The platform allows users to perform global search by running queries in PubMed, and accessing PRAC Safety recommendations on signals. This centralizes all literature searches. Users can save their searches, schedule automatic search, and choose only to search for new articles since their last search, saving time and reducing repetition. All searches are saved in a personal area that allows users to view and document their search histories at any time. The database is updated constantly, providing information about publications, the most recent update dates, and how many articles are indexed. This ensures transparency in the content.

CoVigilAI, an AI-enabled solution for medical literature monitoring, uses advanced algorithms and data analysis to proactively detect adverse drug events and ensure patient safety and regulatory compliance. The platform allows for streamlined tracking of medical and scientific publications across global literature databases like Embase and PubMed, with customizable search string options to facilitate an effortless pharmacovigilance monitoring journey. The platform conducts periodic surveillance of scientific and medcial literature databases, as well as publications from local journals. This includes both global literature surveillance and localized literature. Advanced algorithms categorize Individual Case Safety Reports into valid, potentially invalid, and invalid cases. Automated key entity detection recognizes important entities such as patients, medications and adverse events.

TrominoCARE, a cloud-based Medical Information Call Center software, is designed to automate the daily operations of medical information call centers. It has a comprehensive database to support the entire lifecycle of MICC activities. This includes handling different call types, such as medical inquiries and product quality complaints. TrominoCARE is accessible via mobile phones and tablets as well as desktops. This ensures flexibility and responsiveness on all devices. The platform's key capabilities include process automation to manage all call types, automatic creation of Field Alert Reports, a configurable dictionary for client products, and customized workflows tailored to specific needs. The platform offers a mobile app that allows medical sales representatives and teams to capture and submit information offline. It also has integration capabilities for safety systems and MICC systems.

Sentria is a platform powered by artificial intelligence that was designed for the management of adverse event cases and post-marketing surveillance. It is an intuitive, customizable and automated software solution that is industry-compliant. The platform ensures pharmacovigilance conformity with ICH international regulatory standards and ensures proper evaluation of adverse event following local regulations. Sentria streamlines the capture of reports using an intuitive interface, enhanced by pharmacovigilance automated alerts. It also reduces errors in report capture through intelligent alerts and facilitates processing of reports using international MedDRA and ATC/WHO codes. It improves analytical capabilities by using semantic artificial intelligence in pharmacovigilance. The platform has features like secure access controlled by credentials, auditable logs to ensure compliance, and an encrypted environment.

DrugCard, an AI-enabled platform for data intelligence, is designed to streamline pharmacovigilance by automating the screening of local literature. The platform monitors over 1,000 local medical journals in 55+ countries and supports more than 100 languages, ensuring a continuous, regular and transparent monitoring. DrugCard automates routine tasks to allow Contract Research Organizations to manage more pharmacovigilance and improve screening results. Marketing Authorization Holders can conduct in-house literature reviews more effectively. And freelancers can save up to 70 percent of their time to perform other value-adding work. The platform is designed for new markets and to be cost-effective. It also complies with regulatory requirements.

LifeSphere Safety is the only next-generation SaaS Safety Platform in production that enables touchless case processing, scalable regulatory compliance, and standard global pharmacovigilance work flows. Drive transformational change with LifeSphere NavaX's industry-leading capabilities. These include the latest innovations in analytics, automation, and GenAI technology. Automate repetitive safety tasks with artificial intelligence and robust automation. With the most robust support for global and local regulations, including regular updates to the cloud, you can operate confidently in any market. Use powerful, easy to use tools for dashboards and reporting, operational benchmarking and intelligent signal analyses.

Veeva Vault is a modern system for managing individual safety reports. It supports the intake, processing and submission of adverse event reports for clinical and postmarketed products. Sponsors and CROs are able to process global and local adverse events for drugs and biologics as well as vaccines, devices and combination products. The integration of gateway connections and reporting guidelines streamlines the submission management and distribution of cases to health authorities. Central coding dictionary management automates the semi-annual updates to MedDRA, WHODrug and EDQM. Vault Safety integrates pharmacovigilance processes and systems on a single cloud-based platform to provide proactive patient safety. It uses real-time dashboards, reports, and collaboration to provide visibility for adverse events.

Automated surveillance of any source of data, fully integrated with a GVP IX-compliant signal management platform. GVP-IX compliant signal-management platform integrated into Evidex and ready-to-use off-the-shelf. Modernize and audit-proof all your management processes without the need to switch between platforms or services. Your safety data is worth more than you think. Automating signal detection and management allows you to focus on your organization's value, not just regulatory requirements. Safety signals can be identified from traditional sources such as ICSR databases, FDA Adverse Events Reporting System (FAERS), VigiBase, and clinical trial data. Incorporate new data sources like claims, EHR, or other unstructured data. These data sources can be combined seamlessly to improve signaling algorithms, increase validations and assessment efficiency, and provide faster answers for drug safety questions.

SlimEDC, a cloud-based platform for EDC (Electronic Data Collection), is an EDC solution. The study editor makes it easy to launch retrospective and prospective studies, patient surveys (ePRO) and market research projects. SlimEDC can be purchased as software that is managed by the research sponsor, or as a service where the entire process, from the collection of data to its evaluation, is handled by a professional SlimEDC staff. SlimEDC has been adapted to the EU legislation and environment. The software generates all of the required reports for regulatory agencies. SlimEDC is ISO 9001 & 27001 compliant. Our team has received pharmacovigilance and BHBIA certifications. Independent authorities conduct strict GDPR audits on the legal and data security.