Best Pharmacovigilance Software for Nonprofit

Numerous organizations globally rely on IQVIA to accelerate the drug development process, guarantee the safety and quality of products, enhance commercial efficacy, deliver appropriate treatments to patients, and ultimately promote improved health outcomes by facilitating access to and delivery of healthcare. Transform your approach to clinical development by seamlessly integrating data, technology, and analytics to streamline your trials. The outcome? Quicker decision-making and minimized risks, enabling you to provide transformative therapies at a faster pace. With its expertise rooted in data, sophisticated analytics, and deep industry knowledge, IQVIA offers tailored capabilities to clients throughout the healthcare landscape. Stay informed by exploring the latest insights and updates from IQVIA's data scientists, healthcare professionals, researchers, and other industry experts on crucial topics that resonate with your interests. From emerging industry developments to practical applications of our capabilities, a wealth of information awaits you here. Engaging with this content also empowers you to stay ahead in a rapidly evolving healthcare environment.

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.

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's electronic Trial Master File (eTMF) is a user-friendly digital solution for the organization and storage of documents, images, and various digital assets related to clinical trials. This eTMF incorporates an integrated DIA reference model and complies with regulatory standards. Additionally, Clinevo offers the MICC Intake, a web-based platform designed for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) professionals to efficiently log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Furthermore, Clinevo Safety serves as a comprehensive cloud-based system that ensures ease of use and regulatory compliance throughout the entire Pharmacovigilance process, encompassing PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals, all within a single platform. Lastly, the Clinevo Website Intake tool can seamlessly integrate with Sponsor or CRO websites, offering consumers and reporters an intuitive web interface for easy access and reporting. This innovative suite of tools enhances the efficiency and effectiveness of clinical trial management and safety reporting.

Honeywell's TrackWise Digital® serves as an innovative cloud-based Quality Management System (QMS) aimed at enhancing the efficiency of quality and compliance processes within organizations. Drawing on nearly thirty years of expertise in the field, it features integrated modules that cater to various elements of quality management, such as document control, training oversight, and corrective and preventive actions (CAPA). The platform utilizes cutting-edge digital technologies, including artificial intelligence and machine learning, to deliver actionable insights in real-time, which fosters a proactive approach to quality management. Its adaptable, modular framework ensures smooth integration with current enterprise systems, allowing for quick deployment and growth. By optimizing quality processes and maintaining adherence to industry regulations, TrackWise Digital® enables organizations to accelerate product launches while effectively reducing risks. This comprehensive system not only enhances operational efficiency but also supports continuous improvement initiatives across the quality management spectrum.

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

The K2C PSMF Solution represents an innovative methodology for overseeing the Pharmacovigilance System Master File. Periodic updates to this document are essential whenever there are noteworthy modifications in the pharmacovigilance procedures. Such modifications necessitate collaboration among various roles within the company to edit a document comprised of consistent paragraphs and annexes dictated by regulatory standards. However, coordinating edits can be challenging, especially since certain content must remain exclusive to specific editors and inaccessible to other contributors. The K2C solution addresses this complexity by treating individual paragraphs and annexes as separate documents, facilitating the creation of the final PSMF document through the merging of these various source materials. Additionally, the K2C PSMF Solution encompasses the management of contributions to the PSMF (including both paragraphs and annexes) as distinct entities, the regulation of access rights for both viewing and editing contributions, and comprehensive oversight of the entire document lifecycle, ensuring efficiency and compliance throughout the process. This streamlined approach enhances collaboration while maintaining regulatory adherence.

OpenSourcePV, established by Lionel Van Holle in 2019, aims to leverage free and open-source technologies to enhance pharmacovigilance standards and offer a cost-effective alternative to costly specialized software in this field. Pharmaceutical companies are required to monitor the safety of their products to meet regulatory requirements, but as they expand their product lines and pipelines, the volume of data that needs to be analyzed quickly becomes overwhelming for manual review. Currently, they face a dilemma: invest in an expensive software suite or attempt to develop a solution in-house. OpenSourcePV supports these companies in their journey towards effective quantitative signal detection by providing access to pre-built modules while also enabling customization to fit their unique requirements and data sources. This flexibility allows them to efficiently handle large datasets and improve their overall pharmacovigilance processes.

NewTn's SAFETY is a cutting-edge cloud platform for pharmacovigilance that aims to streamline safety processes and ease compliance for pharmaceutical companies, emerging startups, and contract research organizations. This solution presents a wide array of features, such as scalable cloud infrastructure for enhanced data storage and processing, the ability to reuse data to avoid repetitive entries, real-time alerts and monitoring to swiftly detect adverse reactions, and strong reporting capabilities that aid in creating DSUR and PBRER reports. Specific use cases demonstrate its value in building pharmaceutical safety databases for new companies, offering budget-friendly safety solutions for cost-conscious CROs, improving regulatory adherence for small and medium-sized pharmaceutical firms, and providing thorough safety data analysis and reporting. The platform is distinguished by its user-friendly interface and experience, along with its specialized support for DSUR and PBRER reporting, making it a versatile and customized solution for various stakeholders in the pharmaceutical industry. Moreover, NewTn's SAFETY ensures that all users can effectively navigate the complexities of safety management with confidence and ease.

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.

Harnessing actionable insights from the leading AI-driven clinical analytics platform allows your teams to effectively manage risk and enhance performance throughout studies, systems, sites, and vendor relationships. The cutting-edge technology from Saama is specifically crafted to optimize workflows, automate labor-intensive tasks, and foster improved collaboration among various clinical functions such as operations, medical review, data management, biostatistics, and pharmacovigilance. Both sponsors and CROs depend on Saama's capabilities for data aggregation and AI solutions, which facilitate superior decision-making, minimize delays, and drastically reduce costs and timelines associated with drug development. By leveraging Saama's tools, you can accelerate the pace of clinical trial innovation. When your clinical data is centralized and continuously updated, it simplifies the lives of your ClinOps and medical review teams considerably. Furthermore, Data Managers, often undervalued, can shift their focus from repetitive tasks to the critical data points that truly drive project success, ensuring that their expertise is fully utilized in the process. This transformation not only enhances efficiency but also contributes to the overall quality of clinical outcomes.

Enhance your biomedical research endeavors through the most extensive database of biomedical literature available globally. By utilizing a thorough and contemporary search process, you can access a wealth of biomedical evidence that is both comprehensive and pertinent. Streamline your systematic searches with automated query generation facilitated by user-friendly search forms. Discover critical insights into drug-disease interactions and drug-drug relationships, meticulously curated through extensive indexing efforts. The rapid evolution of biomedical research and development necessitates access to exhaustive information, allowing you to identify potential risks by evaluating all known data. Furthermore, you can monitor safety standards to ensure compliance with regulations while unveiling connections that foster innovation. Embase stands out as a distinctive medical literature database where depth of content exceeds mere quantity. With Emtree indexing of full-text resources and specialized search terminology, you are empowered to locate all significant and up-to-date information, including data that may elude other databases. Scroll down to understand the compelling reasons why regulatory bodies endorse Embase within their best practice recommendations, ensuring that your research is not only thorough but also aligned with industry standards. This commitment to excellence in biomedical literature further positions Embase as an indispensable tool for researchers and practitioners alike.

Aggregate, enrich, and oversee essential information sources on a large scale through unmatched integrations that encompass premium licensed content, the open web, and internal intelligence reservoirs. Harness the capabilities of InfoDesk's information lab to discern critical insights while filtering out irrelevant data. With a legacy of supporting global analysis teams for over 25 years, we have developed robust tools designed to simplify your workflow. By utilizing our established intelligence framework, enhanced with top-tier analytical tools, our solutions facilitate efficient monitoring and analysis, enabling professionals to concentrate on impactful initiatives related to regulatory compliance, pharmacovigilance, competitive intelligence, market insights, and strategic operations. Centralize your vital information, enhance your analytical processes, and equip stakeholders with reliable intelligence, all driven by advanced enterprise-grade AI. Deliver trustworthy intelligence to your stakeholders seamlessly through our cutting-edge deliverable engine, and elevate engagement levels like never before using our interactive dashboards that provide real-time insights. Together, we can revolutionize the way your organization accesses and utilizes information for better decision-making.

Tepsivo offers innovative pharmacovigilance software solutions that enhance the efficiency of drug safety processes through automation and intelligent templates, leading to a significant decrease in administrative workload and related expenses. The Tepsivo Platform is an all-encompassing, cloud-based system that empowers users to oversee all aspects of pharmacovigilance from a single, unified interface. Its notable features encompass a Quality Management System, oversight by a Local Contact Person for Pharmacovigilance (LCPPV), efficient safety reporting and follow-up mechanisms, PSUR tracking, management of signal detection, automated audit trails, compliance monitoring, tools for adverse event intake, literature surveillance, tracking of risk management systems, solutions for managing PSMF, automated reconciliation with partners, and CAPA management. By integrating these modules, the platform guarantees complete transparency, full compliance with regulations, preparedness for inspections, high-quality outputs, rapid processing times, elimination of administrative overhead, and reduced costs. With Tepsivo's solutions, organizations can enhance their pharmacovigilance capabilities while ensuring that they meet industry standards efficiently and effectively.

Oracle Life Sciences Empirica stands out as the premier solution for identifying, analyzing, and managing safety signals that arise from both pre-market and post-market drugs, biologics, vaccines, devices, and combination products. Oracle consistently invests in research and development to enhance the cutting-edge data-mining algorithms and statistical methods utilized in Empirica. This innovative approach allows for the identification of signals significantly earlier, offering risk insights as much as 7 to 22 months in advance of the typical labeling revision timelines based on a time-indexed benchmark. Safety teams engaged in signal management encounter increasing difficulties, including uncovering concealed signals, evaluating data from extensive big data sets, and improving the safety information available before the onset of clinical trials. To explore how emerging methodologies and technologies, such as artificial intelligence, can effectively tackle these evolving challenges, be sure to read our ebook, which provides valuable insights and practical solutions.

Argus stands out as the premier and reliable solution for managing, analyzing, and reporting adverse event cases linked to both premarket and post-market drugs, biologics, vaccines, devices, and combination products. Enhance your case management capabilities with advanced features like integrated automation, optimized workflows, and touchless processing options that adapt to your needs. This mature solution ensures compliance with global drug, vaccine, and device regulations and standards, including E2B(R3), E2B(R2), eVAERS, eMDR, MIR, and IDMP, making it a dependable choice for organizations worldwide. With Argus Advanced Cloud, users gain access to Oracle Analytics, an AI-driven tool that not only reveals valuable insights but also enables quicker, more informed decision-making. As medicinal product safety teams navigate the challenges of increased caseloads, diverse signal detection data sources, and evolving regulations, they must do so with limited budgets and resources, making efficient solutions like Argus essential for their success. Ultimately, Argus helps organizations maintain safety and compliance in a complex landscape while optimizing operational efficiency.

SafetyEasy by EXTEDO is a robust software solution for managing pharmacovigilance and multivigilance, aimed at simplifying the handling of safety cases and vigilance information. It adheres to a wide range of drug safety regulations such as E2B(R3) and HL7 eMDR, while facilitating the necessary creation of regulatory documents including PSUR, PBRER, and DSUR. The software is equipped with features that optimize workflows through email alerts and online dashboards, allowing users to efficiently monitor project progress and adhere to submission timelines. Additionally, SafetyEasy features sophisticated tools like CasEasy AI, which leverages Natural Language Processing to streamline the automation of case creation, alongside a Business Intelligence module that offers an insightful 360° perspective on scientific data, thereby improving case evaluation and safety signal identification. This cloud-based platform is not only quick to deploy but also designed for ease of use, requiring very little training for effective operation. Furthermore, the integration of these advanced functionalities makes SafetyEasy an invaluable asset for organizations aiming to enhance their pharmacovigilance processes.

Quanticate delivers extensive services in pharmacovigilance, which include the establishment and oversight of safety databases specific to pharmacovigilance. These safety databases act as the primary collection point for individual case safety reports gathered worldwide for a company's pharmaceutical products. Keeping these databases current with the latest regulatory guidelines and ensuring they are validated according to international standards and business requirements is crucial. Quanticate underscores the necessity of choosing the appropriate database by evaluating factors such as the costs associated with implementation and maintenance, the availability of hosting models (including internal infrastructure, third-party hosting, or vendor cloud solutions), previous experiences, and how well they integrate with existing systems. They warn that, despite many commercial databases claiming adherence to standards like ISO ICSR ICH-E2B, achieving genuine compliance necessitates meticulous configuration, validation, and ongoing management. Furthermore, ongoing support and updates are critical to maintain the integrity and reliability of these safety databases over time.

The Drug Safety Triager, developed by Clarivate, represents an advanced pharmacovigilance tool aimed at helping life sciences organizations adhere to regulatory standards. This system, which is validated for Good Practice (GxP) compliance and prepared for audits, enhances and organizes the workflow associated with literature reviews, allowing pharmacovigilance professionals to prioritize patient safety by streamlining these processes. Fully compliant with the reporting demands of major global safety regulatory bodies, including the FDA and EMA, the Drug Safety Triager includes a comprehensive validation package with every implementation. The validation documentation is carefully constructed to meet the stringent requirements set forth by the pharmaceutical sector and health authorities. Additionally, every piece of literature referenced is subjected to a meticulous review process that ensures all user actions are recorded, creating a permanent, immutable audit trail for accountability and transparency. This innovative approach not only improves efficiency but also reinforces the commitment to maintaining high standards in patient safety and regulatory compliance.

Ennov's Pharmacovigilance Suite serves as a comprehensive solution for the collection, management, assessment, and reporting of adverse events in both human and veterinary fields, all within a single database framework. It boasts sophisticated tools for signal detection and data analysis, reinforcing adherence to international regulatory standards. Notable features encompass streamlined case intake and triage processes, enhanced user interfaces for data entry, adaptable case input forms, and an extensive range of searchable vocabulary lists. The system accommodates various reporting formats, including both paper and electronic submissions, compatible with CIOMS guidelines, MedWatch 3500s, and ICH E2B standards (R2 and R3). In terms of signal detection and management, it offers extensive data querying options, robust analytical tools, and the ability to compute essential statistical measures such as PRR, ROR, and MGPS. Entirely web-based and user-friendly, the platform is built to meet the standards of 21 CFR Part 11, thereby guaranteeing the integrity and security of data. Moreover, its adaptability makes it suitable for organizations of all sizes, ensuring that users can efficiently navigate the complexities of pharmacovigilance.

Biologit provides an extensive range of software and services aimed at improving safety surveillance in multiple sectors. Their leading offering, biologit MLM-AI, is a comprehensive medical literature monitoring system that utilizes AI technology for both global and local applications. This user-friendly, web-based platform is validated for compliance, resulting in enhanced efficiency for both human and veterinary pharmacovigilance. Notable features encompass integrated search capabilities and customizable literature screening processes, yielding productivity improvements of up to 70% thanks to AI support. Additionally, it presents a flexible and validated SaaS framework that meets GxP standards and adheres to CFR-11 regulations, alongside a database that consolidates significant global and local literature resources while ensuring automatic article de-duplication. Beyond their software offerings, Biologit also provides expert consultancy services related to pharmacovigilance and veterinary pharmacovigilance, further strengthening their commitment to safety in various fields. Their dedication to innovation and compliance positions them as a leader in the industry.

PVSEARCH is a reliable data management system created by Owlpharma Consulting Lda. specifically for professionals in pharmacovigilance. This software as a service (SaaS) facilitates the screening of medical literature by serving as a scientific literature repository equipped with a powerful and customizable search engine. Users are empowered to formulate queries with predefined inputs and Boolean operators, which allows for systematic and automated searches throughout the database. The platform is designed to handle various written forms of substances, including atypical variants, by allowing clients to add custom terms alongside the standard terms already present in the system. PVSEARCH boasts an extensive database that includes significant local publications, such as journals, websites, newsletters, and congress proceedings related to both human and veterinary health in Portugal. Additionally, clients have the option to select specific publications they wish to include in their ongoing search activities. This flexibility ensures that users can tailor their searches to meet their unique needs and access the most relevant information available.

PharmaPendium serves as a robust platform that grants users access to a wide array of FDA and EMA drug approval documents, encompassing essential aspects like pharmacokinetics, pharmacodynamics, and safety evaluations. This resource delivers in-depth insights into drug-drug interactions, side effects, and outcomes from clinical studies, thereby empowering stakeholders to make well-informed decisions during the drug development process and when making regulatory submissions. Its rich database aids researchers and healthcare practitioners in assessing both the efficacy and safety of medications, playing a pivotal role in the progression of pharmaceutical research and enhancing patient care. Users can explore historical regulatory submissions and leverage past precedents to better understand and anticipate agency requirements. The interface allows for a seamless transition from tabular data to dynamic charts, graphs, and other visual tools, making it easier to analyze and interpret findings. Additionally, users can search for information related to adverse events (MedDRA), therapeutic targets, drug indications, and endpoints utilizing standardized data. Result pages effectively connect preclinical research with clinical applications, facilitating a comprehensive understanding of the drug development landscape. Overall, this platform not only streamlines the research process but also fosters collaboration and knowledge-sharing among industry professionals.

The IQVIA Vigilance Platform represents a holistic solution designed to streamline safety and pharmacovigilance tasks, enhancing speed, precision, and overall efficiency. Operating within a secure Software-as-a-Service (SaaS) environment and leveraging advanced proprietary technologies such as artificial intelligence, machine learning, and natural language processing, the Vigilance Platform provides valuable insights that enhance compliance, ensure product safety, and contribute significantly to the product development lifecycle. It comprehensively addresses every facet of pharmacovigilance, managing cases from initial patient reports through processing and submission to regulatory authorities, encompassing all types of cases. With its user-friendly interface, the IQVIA Vigilance Platform is accessible for affiliates, case processing teams, and those involved in signal detection. By adopting a transformative methodology in pharmacovigilance, it bolsters compliance, allowing organizations to concentrate on the rapid delivery of safer and more effective pharmaceuticals and medical devices. This innovative platform not only meets current industry needs but also anticipates future requirements in the evolving landscape of drug safety and efficacy.

PvEdge is a state-of-the-art cloud-based pharmacovigilance software crafted to deliver comprehensive and compliant safety solutions for pharmaceuticals, medical devices, vaccines, and their combinations. It features an all-encompassing safety database that streamlines the management of pharmacovigilance intake, case processing, submissions, AI-driven analytics, and safety signal detection within a single user-friendly interface. This platform is designed to meet both current and forthcoming regulatory standards, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR, thus ensuring worldwide compliance. By harnessing the power of advanced automation through AI and machine learning technologies, PvEdge significantly boosts the efficiency of drug safety database management. Notable functionalities encompass automated literature review, expedited ICSR submissions, intelligent triage processes, automated signal detection, and streamlined document automation. Additionally, the system incorporates a controlled document management feature that facilitates the creation, oversight, and dissemination of essential pharmacovigilance documentation, alongside a risk-based enterprise quality management framework aimed at establishing robust quality control processes and maintaining meticulous training records. Through these diverse capabilities, PvEdge stands out as an invaluable tool for organizations committed to upholding the highest standards in drug safety.