Best Pharmacovigilance Software in China

DF mSafety AI, a cloud-based platform, uses AI/ML and automation for a great user interface and efficiency in Safety Case Management, Neutraceutical, Vaccines and Medical Devices. DF mSafety AI was built on Datafoundry’s Integrated Cloud Platform – DF Safety 4.0, which supports scalable, secure AI/ML-driven Safety Case and Signal Management. It also includes pre-built connectors for enterprise systems and adheres to industry standards and regulatory requirements.

Clinevo electronic trial master file (eTMF), is an electronic Trial Master File in electronic format (digital content). It can be used to organize and store documents, images and other digital content for clinical trials. Clinevo electronic Trial Master File eTMF has an inbuilt DIA reference model that meets regulatory guidelines.

Flex Databases is an innovative, unified, and compliant electronic clinical platform that provides software solutions for clinical trials: pharmaceutical companies and CROs. Our system is composed of: - Clinical Trial Management System - Electronic Trial Master File - Project Management & Budgeting solution specifically designed for the clinical trials industry - Pharmacovigilance System - Learning Management System It was possible to create a flexible platform thanks to our unique experience and a qualified team of more than 100 professionals with a deep understanding the clinical trial process.

Honeywell TrackWise Digital® is a cloud-based Quality Management System (QMS) designed to streamline and enhance quality and compliance processes for businesses. With decades of expertise behind it, the platform offers robust modules for managing critical functions like document control, training programs, and corrective and preventive actions (CAPA). Utilizing advanced technologies such as artificial intelligence and machine learning, TrackWise Digital® delivers real-time insights to help organizations identify and address quality issues proactively. Its modular, flexible design ensures smooth integration with existing enterprise systems, enabling quick deployment and easy scalability. By optimizing quality operations and ensuring regulatory compliance, TrackWise Digital® supports organizations in accelerating product delivery while reducing operational risks.

Cloudbyz Safety & Pharmacovigilance Solution, a cloud-based solution, is designed to streamline drug safety and pharmacovigilance for pharmaceutical and life sciences companies. The solution automates the process of collecting data, processing it, analyzing it and reporting it in compliance with global regulations. 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. The benefits of our solution are listed below- 1. Improved Efficiency with Automation 2. Increased data accuracy 3. Real-time visibility 4. Improved Collaboration 5. Enhanced regulatory compliance

K2C PSMF solution is a modern way to manage the Pharmacovigilance System Master File. This document is typically updated periodically to reflect significant changes in the process of pharmacovigilance. Multiple company roles must be involved in editing the document, which is composed of paragraphs or annexes that remain the same due to regulations. Co-editing can be complex. In addition, some content should be reserved for certain editors and not made available to others. K2C Solution allows you to handle the paragraphs and annexes separately as a single document, then offers the option to create the PSMF as a merged document from various source documents. K2C PSMF Solution includes managing PSMF contributions as separate documents (paragraphs and annexures), management of access rights to view or edit PSMF contributions, and management of entire lifecycle.

OpenSourcePV was founded by Lionel Van Holle, in 2019. The company's goal is to use free and open source technologies in order to raise standards in pharmacovigilance. It also aims to provide a cheaper alternative to expensive pharmacovigilance software. Pharma companies must monitor their products' safety to meet their regulatory obligations. As they begin to have multiple products and a strong pipeline, the amount data to be reviewed becomes too large to review manually. Currently, there are two options for companies to benefit from quantitative analysis: either they purchase expensive tools or they build their own. OpenSourcePV is a tool that helps them on their journey to quantitative signal detection. They can use pre-built modules or build something customized for their needs and data sources.

Qualio is a one-stop solution for quality and compliance management. It's ideal for growing companies in healthcare and life sciences. Qualio is reliable, affordable and easy to use. It helps companies build life-saving products faster and achieve 100% ISO, GxP and FDA compliance. Qualio makes it easy for companies to manage document control, training and NCRs, audits as well as suppliers, complaints, and other tasks in one platform.

NewTn SAFETY is a cloud-based pharmacovigilance platform that accelerates safety processes and simplifies compliance for pharmaceutical companies, startups and contract research organizations. The system includes a comprehensive set of features including cloud-based scalability, data reusability, real-time monitoring, alerts, and monitoring to detect adverse reactions quickly, and robust reporting functionality that facilitates the generation of DSUR reports and PBRER. The system's benefits are highlighted by tailored use cases, including establishing pharmaceutical safety databases in startups, providing cost effective safety systems for budget-conscious CROs, improving regulatory compliance for small- and medium-sized pharmaceutical firms, and delivering comprehensive data analysis and reporting. The platform's intuitive UI/UX, as well as its support for DSUR/PBRER reports, make it a custom solution.

PubHive Navigator, an AI-powered platform, streamlines scientific literature workflows and safety workflows in life science companies of any size. It offers end-to-end solutions for literature review and curation, annotations, collaboration, searching reports, citing research, and managing it. The platform includes AI-powered smart workspaces that allow for centralized literature management. It also allows for collaborative research writing, team communication, reuse rights, and document delivery integrations. PubHive Navigator simplifies enterprise scientific literature and safety workflows. It is a flexible platform for teams working in drug safety, pharmacovigilance and clinical affairs.

IQVIA is trusted by thousands of organizations worldwide to accelerate drug development, improve product quality and safety and commercial effectiveness, get the right treatments for patients, improve healthcare delivery and access, and ultimately drive better outcomes. Connect data, technology and analytics to optimize clinical development. The result? The result? Faster decision making and lower risk, so you can deliver life-changing treatments faster. IQVIA offers specialized capabilities to customers in the healthcare industry, thanks to its foundation in data, advanced analytics and expert insights. Watch the latest from IQVIA data scientists and doctors, as well as other subject matter experts, on the topics that are important to you. You can find everything you need, from industry trends to how our capabilities are being applied to help, here.

Fusion is Axiom’s proprietary, cost-effective and easy-to-use eClinical solution. It is aimed at small to medium-sized device, pharma and biotech companies. Axiom's Fusion eClinical Suite allows you to add-on any Modules that meet your study needs. Are you running a small study? You can choose the base configuration with EDC and DM, as well as AE/SAE tracking. Are you looking for something more? To make managing your study easier, you can include powerful Modules like Inventory Tracking, RTSM, Safety Management. You can save time by electronically capturing your study data - even offline! Once you have an internet connection, your data will sync to your Fusion databases. Real-time records available for subject screening activities. Fusion Safety Database allows you to manage pharmacovigilance events.

The industry's best AI-powered clinical analytics platform provides actionable insights that enable your teams to manage risk, improve performance across sites, studies, and vendors. Saama's state-of-the art clintech is designed to streamline workflows, automate tedious processes, and improve collaboration across clinical operations. Saama is trusted by sponsors and CROs for data aggregation, artificial intelligence solutions, and improved decision-making. This can help to reduce drug development costs and timeframes, as well as eliminate delays. Saama can help you get on the fast track for clinical trial process innovation. Your ClinOps and medical review team will find it much easier to access all of your clinical data in one place. Data managers are often undervalued. They can now focus on the data points that are important by eliminating manual work.

The world's largest biomedical literature database will help you improve your biomedical research. You can find more biomedical evidence by searching the most up-to-date, relevant and comprehensive biomedical research. Use intuitive search forms to automate your queries and create systematic searches. Deep indexing manual curated to uncover drug-disease relationships. Comprehensive information is essential for biomedical research and drug development at an increasingly rapid pace. You can anticipate risk by assessing all that is known. To meet regulations, you track safety. You discover connections that can be used to drive innovation. Embase is a unique database of medical literature that goes beyond content. Emtree indexing full-text content and dedicated searches terms allows you to find all relevant and current results. This includes information that is not available in other databases. Scroll down to see why regulatory agencies recommend Embase for their best practice guidelines.

DF mSignal is a modular and scalable safety signal management system that enhances the efficiency of signal detection processes and risk management across pharmaceuticals and medical devices. It also includes cosmetics and nutraceuticals. The platform provides active and passive monitoring with real-time monitoring product-event combination, customizable clinical risk indicators, and an interactive interface with advanced analytics. It integrates seamlessly into MedDRA, WHO DD, clinicaltrial.gov and electronic data collection systems, providing a comprehensive safety solution for professionals. DF mSignal AI automates statistical scores to save time and ensure accuracy in signal detection. The system is designed to comply with all applicable regulations, including 21 CFR Part 11, data privacy and integrity controls, as well as GxPs. This ensures compliance and security.

With unparalleled integrations of premium licensed content, open web and internal intelligence, you can aggregate, enrich and monitor important information sources at scale. InfoDesk’s information lab helps you identify the signal and eliminate noise. We have been building powerful tools for global analysis teams over the past 25 years. Our solution streamlines monitoring, analysis and reporting by leveraging our proven workflow, enhanced with enterprise-grade tools. This allows professionals to focus on high impact initiatives across regulatory and pharmacovigilance functions, as well as competitive, market and strategic intelligence. Centralize key data, streamline analysis and empower stakeholders with trustworthy intelligence powered by enterprise-grade AI. Our industry-leading deliverables engine puts trusted intelligence in the hands of your stakeholders. Dynamic dashboards will increase engagement.

Tepsivo’s pharmacovigilance solutions are designed to streamline the drug safety process through automation and smart template, reducing administrative burdens as well as associated costs. The Tepsivo Platform, a cloud-based application, allows users to manage pharmacovigilance in a single location. Key features include a Quality Management System (QMS), Local Contact Person for Pharmacovigilance Oversight (LCPPV), streamlined safety reporting, follow-up tools and signal management tracking. Automated audit trails, compliance tracking and adverse event intake tools are also included. These integrated modules provide full transparency, 100% inspection readiness, high-quality, rapid speed, minimal cost, no administrative overhead and minimal cost.

Oracle Life Sciences Empirica, the leading solution on the market, is used to detect, analyze, and manage safety signals that originate in pre-and post-market drugs and biologics, vaccines and devices, as well as combination products. Oracle continuously researches, develops and advances the state of the art data-mining algorithm and statistical techniques that Empirica uses. Empirica's ability to detect signals with a longer lead-time allows it to provide risk insights 7-22 months earlier than label revision dates based on a time-indexed standard. Safety teams that are responsible for signal management have to face new challenges. They must find hidden signals, assess information from multiple large data sets, and provide better safety information even before clinical trials begin. Learn how new technologies and methodologies, such as artificial intelligent, can help to address these challenges. Read our ebook.

The leading solution on the market for processing, analyzing and reporting adverse events originating from pre- and post-market drugs and biologics, vaccines and devices, as well as combination products. Improve your case management efficiency by implementing innovative capabilities such as workflow optimization, built-in automation and conditional touchless handling. Argus is a mature and reliable solution that provides proven compliance with drug and vaccine regulations and standards around the world. This includes E2B (R3), E2B (R2), eVAERS, eMDR, MIR, and IDMP. Oracle Analytics is a powerful, flexible AI-powered solution included in Argus Advanced Cloud. It allows users to discover new insights and make more informed decisions. The Medicinal Product Safety teams are under enormous pressure to manage an ever-increasing number of cases, new sources for signal detection data and changing regulations with limited budgets and resources.

SafetyEasy by EXTEDO is a comprehensive multivigilance software that streamlines the processing of safety data and cases. It ensures compliance with a variety of drug safety regulations including E2B (R3) and HL7 eMDR and supports the production of essential regulatory documents such as PSUR PBRER and DSUR. The platform provides features such as workflow optimization via email notifications and online dashboards that allow users to track project progress and meet submission deadlines efficiently. SafetyEasy incorporates advanced modules such as CasEasy AI which uses Natural Language Processing to automate the case creation, and a Business Intelligence Module that provides a 360deg dynamic view of scientific data in order to enhance case analysis. SafetyEasy™ is a cloud-based solution that is easy to use, quick to implement and requires little training.

Quanticate provides comprehensive pharmacovigilance, including the management and provision of pharmacovigilance databases. A pharmacovigilance database is the central repository of individual case safety reports for the company's medicines. These databases must be up-to date with the latest regulatory requirements, and validated in order to meet international standards and company needs. Quanticate stresses the importance of choosing the right database, taking into account factors such as implementation costs, maintenance costs, availability of hosting models (internal infrastructure or third-party hosting), prior experience, and compatibility with existing systems. They warn that, while many commercially-available databases claim compliance with ISO ICSR ICH E2B, true conformance requires careful setup and validation.

Clarivate's Drug Safety Triager, a next-generation pharmacovigilance system, is designed to help life sciences organizations meet regulatory requirements. This GxP validated, compliant and audit-ready software manages and streamlines literature review workflows, allowing pharmacovigilance specialists to focus on patient care by simplifying literature reviews. The platform is fully compliant and validated with global safety regulatory agencies like the FDA and EMA. Each implementation of Drug Safety Triager comes with a validation pack. The validation process, as well as the documentation that goes with it, is aligned with pharmaceutical industry regulations and health authority regulations. All literature references are subjected to a systematic review that captures all user actions and creates a permanent audit trail.

Ennov's Pharmacovigilance Suite provides a complete solution for collecting, assessing and reporting adverse human and veterinary events in a single database. The suite provides advanced data analysis and signal detection tools to ensure compliance with global regulatory requirements. The system includes features such as efficient case intake and data entry with optimized user interfaces, flexible case input form, and searchable vocabularies. The system supports paper and electronic report formats, including CIOMS and MedWatch 3500s standards (R2 or R3), as well as ICH E2B. It provides powerful analysis capabilities and comprehensive data queries for signal detection and management. The platform is 100% user-friendly and designed to comply 21 CFR Part 11 ensuring data security and integrity.

Clinevo Safety is a cloud-based, user-friendly, regulatory-compliant, end-to-end pharmacovigilance and drug safety system. This all-in one platform includes PV intake, case-processing, regulatory submissions through an AS2 gateway and analytics. It is built on a simplified tech stack and offers extensive configurations without requiring customizations. This results in a lower total cost of ownership and easy maintenance. The system alerts users when cases are approaching their due dates to ensure timely compliance. Advanced automation and AI features streamline the case processing effort, while easily configurable workflows speed up case management. Advanced analytics provide powerful and actionable insights. It is a web application that is easy to use and accessible anywhere, anytime and on any device using basic internet or intranet browsers such as Chrome and Firefox.

AccelSafety, a comprehensive pharmacovigilance solution developed by Techsol Life Sciences around the Oracle Argus Safety software, is designed to provide a unified platform for the collection, medical assessment and regulatory reporting of post-marketing and clinical safety surveillance data. The fully managed cloud-based solution helps emerging biopharma companies, devices manufacturers, and service provider to manage safety data and make informed business decisions aligned with global compliance requirements. The key benefits include Argus Safety implementation and migration with a 70% reduction in effort; secure migration of legacy data to the AccelSafety cloud; simplified lean cases processing through customized configurations, native automation, and comprehensive operational insights via advanced reporting, line listings, analytics packages, and 24/7 Argus Safety Service Desk Support for user requests, incident management, and change management.