Alternatives to K2C PSMF Solution
Compare K2C PSMF Solution alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to K2C PSMF Solution in 2026. Compare features, ratings, user reviews, pricing, and more from K2C PSMF Solution competitors and alternatives in order to make an informed decision for your business.
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Dot Compliance QMS
QMS for Life Sciences
Dot Compliance provides the industry’s first off-the-shelf QMS solution – ready to deploy from day one, with little to no setup required, while also incorporating industry best practices and standards that address the latest global regulatory requirements. Powered by the Salesforce.com platform, our solutions enable life science organizations to quickly digitize their quality and compliance processes including Document Management, Training Management, Change Control, CAPA, Customer Complaints. Compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, 27001 & MORE! Processes included: ▶ Document Management ▶ Training Management ▶ Quality Event Management ▶ CAPA Management ▶ Change Management ▶ Complaint Management ▶ Audit Management ▶ Supplier Quality Management ▶ Risk Management ▶ Design Control ▶ Deviations/Non-conformances ✔ Seamless Install ✔ Cost Effective ✔ One-Stop-ShopStarting Price: $10,000 / Annually -
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SimplerQMS
SimplerQMS
SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry. This comprehensive QMS platform helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, ICH Q10, and others. The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience. SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.Starting Price: $13,750/year -
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MSB Docs
MSB Docs
MSB Docs simplifies digital document management for businesses of all sizes with secure, compliant, and legally binding Electronic Records and Electronic Signatures (ERES). It complies with US FDA 21 CFR Part 11, EU GMP Annex 11, and EU eIDAS (SES, AES, QES), making it ideal for regulated industries like healthcare and life sciences, while enabling cross-industry use across the EU. In India, MSB Docs adheres to the IT Act 2000 and supports DSC, Aadhaar-based eSignatures, and eStamping, making it the most trusted digital documentation platform. Trusted by leading organizations in pharma, BFSI, government, and education, MSB Docs offers: 1. eSign – Compliant digital signatures 2. CRA App – Simplified Clinical Research Associate workflows 3. Smart Forms – Dynamic, logic-based digital forms 4. eStamp – Legally valid, tamper-proof stamping MSB Docs enables organizations to digitize, manage, and automate document workflows.Starting Price: $25.00/month/user -
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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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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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AIFMD Annex IV Reporting
Matterhorn Reporting Services
The AIFMD Annex IV transparency reporting requirements represent a major challenge for Alternative Investment Fund Managers (AIFM). All authorised and registered AIFMs are required to periodically report to their local regulators on each AIF they manage or market within the European Union. Matterhorn offers a smart AIFMD Annex IV reporting software solution which operates more efficient than other solutions that are available in the market, allowing you to reduce your annual regulatory reporting costs significantly. It requires minimal input to create both the AIF and AIFM AIFMD Annex IV reports. Subsequent AIFMD Annex IV reports take very limited time to complete as data is re-used to a large extent. XML AIFMD Annex IV output files are created and can be uploaded with a few mouse clicks to all EU regulators. -
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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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dezzai Sentria
dezzai
Sentria is an artificial intelligence-powered platform designed for adverse event case management and post-marketing surveillance. It offers an intuitive, customizable, automated, and industry-compliant software solution to enhance the capacity, speed, and precision of adverse event management. The platform facilitates pharmacovigilance compliance with ICH international regulatory guidelines and ensures the proper evaluation of adverse events following local regulations. Sentria streamlines capturing reports through an intuitive interface enhanced by pharmacovigilance automation, reduces capture errors through intelligent alerts, and facilitates report processing using international MedDRA, and ATC/WHO coding. It increases analytical capabilities using semantic artificial intelligence for pharmacovigilance. The platform includes features such as secure access controlled with credentials, auditable logs for compliance, and an encrypted cloud environment. -
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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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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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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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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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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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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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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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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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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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Dialog
Clarivate
Dialog offers a modular, end-to-end pharmacovigilance literature monitoring solution that supports organizations tasked with drug safety reporting by streamlining and automating the entire literature triage process. It provides access to over 140 authoritative scientific and medical literature databases, such as MEDLINE, Embase, and Biosis, standardizing content across sources to ensure consistent precision search, deduplication, and structured XML output. The DialogML engine employs artificial intelligence to rank search results by patient-safety relevance, highlight key safety concepts, and tag references related to ICSRs (Individual Case Safety Reporting), aggregate reports (PBRER, PSUR, DSUR), and safety signals, so reviewers can rapidly identify high-priority articles. The Dialog Alerts Manager simplifies alert creation and management, offering bulk editing, audit trails of search strategy changes, scheduling flexibility, and delivery history tracking. -
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LifeSphere Safety
ArisGlobal
LifeSphere Safety offers the only unified, next-generation SaaS Safety platform in production, built to enable touchless case processing, scalable compliance, and standardized global pharmacovigilance workflows. Drive transformative change with industry-leading capabilities, including the latest innovations in automation, analytics, and GenAI technologies powered by LifeSphere NavaX. Drive significant efficiency gains through touchless case processing by leveraging robust, production-ready automation and artificial intelligence to streamline repetitive safety tasks. Operate confidently in any market with the most robust turnkey support for global and regional regulations, including regular cloud upgrades to ensure future-proof compliance. Turn safety into a value center by leveraging powerful, easy-to-use tools for reporting and dashboarding, operational benchmarking, and intelligent signal analysis. -
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Thrana Safety Database
Thrana Softech
Thrana Safety Database, a cloud-based pharmacovigilance and drug safetysystem. Designed with user-friendliness in mind, this end-to-end solution seamlessly integrates key functionalities such as PV Intake, Case Processing,Regulatory Submissions (AS2 Gateways),Regulatory Reports, and Analytics—allaccessible from a centralized platform.Starting Price: $17000 USD/year -
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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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AmpleLogic Document Management
AmpleLogic
AmpleLogic EDMS Software is a power-packed electronic document management system exclusively designed for Pharmaceutical and Biotech companies, developed, and implemented exclusively to meet the cGMP needs of Pharma domain with 21CFR Part 11 compliance, EU Annex 11 compliance can easily eliminate all the challenges faced by different companies AmpleLogic EDMS is a paperless document management system enables you to experience the effortless handling of all the documents and information. Various activities like document creation, review, approval, editing, document comparison, version control, parallel reviews are part of AmpleLogic Document Management System. -
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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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CoVigilAI
CoVigilAI
CoVigilAI is an AI-enabled medical literature monitoring solution that employs advanced algorithms and data analytics to proactively detect and manage adverse drug events, ensuring patient safety and regulatory compliance in real time. The platform offers streamlined tracking of scientific and medical publications across prominent global literature databases such as PubMed and Embase, with customizable search strings facilitating an effortless pharmacovigilance literature monitoring journey. Periodic surveillance of scientific and medical literature databases and publications from diverse local journals is conducted, encompassing both global literature monitoring and localized literature surveillance. Advanced algorithms categorize Individual Case Safety Reports (ICSRs) into valid, potential, and invalid cases, while automated key entity detection efficiently recognizes crucial entities like patients, medications, adverse events, and designated medical events. -
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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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Compier Literature Screening
Techsol Life Sciences
Compier Literature Screening is an AI-driven platform designed to assist pharmacovigilance professionals in efficiently screening abstracts, full texts, and translated articles to identify patients, authors, events, products, and safety-related information. The platform offers built-in integration with online biomedical databases such as Medline and supports bulk uploading of literature records from sources like Embase, conference presentations, and PDF journals. It performs automated duplicate checks for each literature search and utilizes validated AI models for automatic screening and annotation of entities. Users can configure scalable literature screening workflows tailored to specific requirements and global regulations. The system facilitates communication with third-party vendors to obtain full texts and includes built-in translation capabilities. It also integrates with safety systems, such as Oracle Argus Safety, to transmit ICSR-relevant articles. -
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SafetyEasy
AB Cube
Efficient drug safety operations with the technological expertise of industry veterans begins here. Align international pharmacovigilance operations teams with an intuitive, unified, cloud-based safety system trusted by industry leaders. SafetyEasy® Suite is a multivigilance management solution which integrates automation with existing drug safety processes. Growing biotechnology firms trust individual vigilances provided by AB Cube for their safety regulatory processes. Life sciences organisations manage adverse event reporting and stay compliant with the latest regulations with SafetyEasy® Suite. SafetyEasy® Suite is AB Cube’s all-in-one ecosystem for automated multivigilance management. Built to make safety simple, scalable, and smart. Designed for organizations of all sizes, it’s a modular, cloud-based platform that automates every step of the vigilance process, from early stage data capture to regulatory reporting and advanced analytics. Flexible and compliant by design, -
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Agatha
Agatha
Agatha offers a suite of cloud-based applications tailored to the life sciences industry, enabling centralized management of documents and processes across clinical operations, quality, regulatory, and training functions. It supports biotech, pharmaceutical, medical-device, and contract-research-organization workflows by offering modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, SOP creation and approval, Quality document management for CAPAs, deviations, and change controls, and regulatory document management. Agatha enables streamlined document creation, review, approval, storage, and sharing in one unified system, supports paperless transformation to reduce administrative burden and strengthen data security, and is built on a global-compliance architecture addressing standards like 21 CFR Part 11, GDPR, and EU Annex 11. -
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Fusion eClinical Suite
Axiom Real-Time Metrics
Fusion is Axiom’s proprietary easy-to-use and cost-effective eClinical solution that is focused on small to medium sized device, pharma, and biotech companies. With Axiom’s Fusion eClinical Suite, you can add-on any Modules to meet your study requirements. Running a small study? Just choose the base configuration with EDC, DM and AE/SAE Tracking. Running something more complex? Include powerful Modules such as Inventory Tracking, RTSM, Safety Management to make the management of your study so much easier. Save time by capturing your study data electronically – even when offline! Data syncs to your Fusion databases once an internet connection is established. Access real-time records for Subject screening activities. Safety Database for the management of pharmacovigilance events directly within Fusion. -
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Speedpdf
Beijing Spacewalk Technology
A simple and practical free PDF editor software that allows users to edit PDFs like professionals and update your own PDF documents quickly and easily. Edit the document, you can edit and modify text, paragraphs, images, etc. on the fly. Protect important files and prevent others from copying or editing sensitive information in PDF. Page management, merge or split PDF documents; crop, delete, add, sort and rotate pages. Support stamps, watermarks, automatically generate bookmarks, etc. to make professional documents. -
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SlimEDC
Altamira
SlimEDC is a cloud platform for EDC – Electronic Data Collection. Retrospective and prospective studies, patient studies (ePRO), and market research projects are ready to launch in no time, using the provided study editor. SlimEDC is available as software, that is fully managed by the research sponsor or as a complex service, where the entire process up to the evaluation of data is provided by a professional SlimEDC team. SlimEDC is adapted to the EU environment and legislation. The respondents are contracted electronically, the software generates all the legally required reports for regulatory organizations. SlimEDC is ISO 9001 and 27001 compliant. Our team is BHBIA certificated and has undergone pharmacovigilance training. The legal and data security is subject to strict GDPR audits conducted by independent authorities. -
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Validfor
Validfor
Validfor is a secure, modular digital validation platform that centralizes the entire validation lifecycle on a single, paperless system. Designed specifically for regulated industries, Validfor enables efficient validation while ensuring full compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. The platform supports electronic records and advanced electronic signatures with full audit trails, role-based workflows (Author, Reviewer, Approver), and complete CSV compliance. All documents and records are securely managed in a centralized repository, capturing every change with full traceability to protect data integrity and Quality Assurance. Validfor offers integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, enabling seamless impact assessments, CAPA tracking, Computer Software Assurance (CSA), and audit-ready lifecycle management. -
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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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Veeva Vault Safety
Veeva
Veeva Vault Safety is a modern individual case safety report management system that supports the intake, processing, and submission of adverse events for clinical and post-marketed products. Within one system, sponsors and CROs can process global and domestic adverse events for drugs, biologics, vaccines, devices, and combination products. Built-in gateway connections and reporting rules streamline the submission management of cases to health authorities and distribution to partners. Central coding dictionary management automates semi-annual MedDRA, WHODrug, and EDQM updates. Vault Safety unifies pharmacovigilance systems and processes on a single cloud platform to deliver proactive patient safety. It leverages real-time reports and dashboards and seamless collaboration to provide visibility and compliance for adverse events. -
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DF Literature Monitor
Datafoundry
DF Literature Monitor is an advanced AI-powered solution designed to automate the monitoring of vast amounts of literature and optimize safety vigilance processes. It integrates with major global and local literature sources for simultaneous article retrieval, employing semantic search to identify relevant articles efficiently. The platform features automatic de-duplication, extraction of minimum safety information, and auto-population of safety case forms, which can be submitted to safety databases in E2B or Excel/PDF formats with a single click. Additionally, it offers automated translation of abstracts and full articles into English. DF Literature Monitor includes configurable workflows to facilitate collaboration and quality control among pharmacovigilance teams. By leveraging this solution, teams can save up to 60% or more time and effort in the literature monitoring process while ensuring quality and compliance. -
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cubeSAFETY
CRScube
cubeSAFETY is a pharmacovigilance platform built to help safety teams manage adverse-event reporting, regulatory submission and case processing in a compliant, efficient workflow. The system supports ICH E2B and regional reporting standards, enables submissions to FDA, EMA, CDE, MFDS and PMDA via dedicated gateways, and automatically translates and formats data for CIOMS and XML export. It includes AI-powered medical-coding suggestions, duplication-detection, import of CIOMS PDF files, real-time submission-tracking dashboards, and full integration with other CRScube modules such as cubeCDMS. The platform is designed to streamline safety-case entry, ensure high data quality through built-in validation, and simplify workflows for global regulatory compliance while reducing manual burden and budget overhead. -
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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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DrugCard
DrugCard
DrugCard is an AI-powered pharmacovigilance platform that helps pharmaceutical companies, CROs, and drug safety teams automate key PV workflows. The platform supports global and local literature monitoring, regulatory intelligence, and adverse event management, helping teams reduce manual screening, identify relevant safety information faster, and maintain audit-ready processes. DrugCard combines AI-driven article pre-assessment, summaries, translations, keyword highlighting, notifications, reporting, audit trails, and case management tools in one connected system. With coverage of 121+ countries, 2,200+ local medical sources, and 100+ languages, DrugCard is designed for MAHs, QPPVs, LQPPVs, regulatory teams, and PV professionals who need scalable, transparent, and compliant automation while keeping human experts in control of final decisions.Starting Price: individual -
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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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Clinevo Safety
Clinevo Technologies
Clinevo Safety is a cloud-based, user-friendly, regulatory-compliant, end-to-end pharmacovigilance and drug safety system. This all-in-one platform encompasses PV intake, case processing, regulatory submissions via an AS2 gateway, analytics, and safety signal capabilities. Built on a simplified technology stack, it offers extensive configurations with minimal customizations, resulting in lower total cost of ownership and easy maintenance. The system provides end-user alerts for cases nearing due dates, ensuring timely compliance. Advanced automation and AI features streamline case processing efforts, while easily configurable dynamic workflows expedite case management. The platform delivers powerful and actionable insights through advanced analytics. As a user-friendly web application, it is accessible anytime, anywhere, and on any device with basic internet or intranet using browsers like IE, Chrome, and Firefox. -
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ActReady
ActReady
ActReady is an EU AI Act compliance platform built for SMBs, startups, and SaaS companies. It helps businesses classify their AI systems by risk level, generate all required compliance documents, and track regulatory obligations — before the August 2, 2026 enforcement deadline. Key features: - Free AI risk classifier (no account required) — get your risk tier in 60 seconds - AI-generated compliance documents: Annex IV technical documentation, risk management plans, human oversight plans, transparency notices, data governance docs, and post-market monitoring plans - Obligation tracker to manage compliance tasks across all your AI systems - Audit pack export — download all documents as a zip for regulators - GDPR & ISO 27001 overlap mapping - Disclosure snippets for Article 50 transparency requirements Plans start free. Paid plans from €29/month. No legal background required.Starting Price: €29/month -
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python-docx
python-docx
python-docx is a Python library for creating and updating Microsoft Word (.docx) files. Paragraphs are fundamental in Word. They’re used for body text, but also for headings and list items like bullets. You’re free to specify both width and height, but usually, you wouldn’t want to. If you specify only one, python-docx uses it to calculate the properly scaled value of the other. This way the aspect ratio is preserved and your picture doesn’t look stretched. If you don’t know what a Word paragraph style is you should definitely check it out. Basically, it allows you to apply a whole set of formatting options to a paragraph at once. python-docx allows you to create new documents as well as make changes to existing ones. Actually, it only lets you make changes to existing documents; it’s just that if you start with a document that doesn’t have any content, it might feel at first like you’re creating one from scratch.Starting Price: Free -
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GoVal
AdventSys Technologies
GoVal is a paperless validation lifecycle platform for regulated industries like pharma and biotech. It supports IQ/OQ/PQ protocols, full document control, audit-ready trails, and compliance with FDA 21 CFR Part 11 and EU Annex 11. Role-based workflows and e-signatures streamline approvals. Dedicated risk assessment tools help evaluate change impacts and ensure regulatory alignment. Integration-ready via APIs, GoVal connects with ERP/LIMS systems securely. Real-time dashboards, alerts, and GoVal AI enhance efficiency by automating risk analysis, test case creation, and document drafting—unlocking intelligent automation with tangible impact. GoVal lowers manual validation overhead, speeds up audit preparation, and shortens product validation cycles—helping organizations realize ROI quickly. -
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GxPLABS
GxPLABS
GxPLABS is a digital solutions provider offering comprehensive end-to-end software products tailored for regulated industries. Their extensive product list includes systems for SOP management, document management, learning management, laboratory information management, quality management, and more. The platform is designed to be platform-independent, low code, and AI-based, supporting flexible deployment and customization. GxPLABS solutions comply with industry standards such as 21 CFR Part 11, Annex 11, ISO 9001, and ISO 27001, ensuring regulatory alignment. With over 10 years of experience serving customers across more than 10 countries, they provide expert client support and scalable, complex technology solutions. Businesses can also develop fully customized software using their platform to meet unique needs. -
45
TPdoc
TaxModel International
TPdoc provides a central platform for transfer pricing documentation, generating automated, customized OECD-compliant master and local files in Microsoft Word with vertical (future and past) and horizontal (country and entity) roll-forwards, dynamic templates that expand per transaction, and one-time setup of intercompany transactions per fiscal year. Its intuitive workflow management visualizes sequential tasks, file status, planner-reviewer roles, deadline monitoring, and notifications, enabling segmented P&L analysis complete with audit trails. User roles linked to document status and least-privilege access controls ensure secure, multi-stakeholder collaboration, while in-tool training capabilities support junior professionals. A rich content library of reusable text cards, annex templates, and step-by-step guidance ensures consistency and full compliance with the OECD Transfer Pricing Guidelines. -
46
Axis AI
Axis Technical Group
There’s a wide range of solutions available today for automatically extracting data from structured and semi-structured content and documents, such as databases, websites, or paper-based forms, all of which can be easily read by machines using templates or sets of predefined or custom rules. However, some businesses such as real estate, healthcare, energy, and others still rely heavily on unstructured documents. These are inconsistent in layout or form, or contain key information in English-language sentences, paragraphs, or randomly throughout the documents, making them virtually impossible for machines to understand. Axis AI offers a far better choice with a revolutionary solution for classifying and extracting information from unstructured content. Using proprietary algorithms, including those used to perform Natural Language Processing (NLP), Axis AI reads and extracts data from sentences, paragraphs, or entire pages written in natural English. -
47
K2C eSignature for SharePoint
K2C Solutions
K2C eSignature enables the use of SharePoint (from 2010 up to 2019 version) to electronically sign any document or record in compliance with US 21 CFR part 11, European Annex 11 and similar regulations. After the installation, a new action "eSignature" is available both in SharePoint Designer or Nintex workflow, if you are using this additional tool. This action can be added at any step of the workflow, in order to collect one or more user signatures without the need of any custom development or coding knowledge. Including views to verify eSignature records for selected item/document and reports dedicated to managers in order to display all electronically signed items/documents in a given SharePoint site and in selected year/month. Able to dynanically retrieve the appropriate signer from any SharePoint list that is managing the assignement of company roles. -
48
Webdox
Webdox
Webdox is the leading company in Latin America that provides Contract Lifecycle Management (CLM) solutions for managing agreements, supporting Spanish, Portuguese and English. Our purpose is to achieve fair, efficient and transparent business relationships. We do it by connecting organizations through an intuitive platform that enables them to automate contract assembly and effectively collaborate on their agreements. Manage all requests for new contracts in one place, connecting the business areas with the legal area, with your external lawyers or with other areas that you need. Design standardized forms for use throughout the company, ensuring that each request is as complete and clear as possible, also automating the generation of a new contract, annex or document with the information provided.Starting Price: $800 per year -
49
Google Docs
Google
With Google Docs, you can write, edit, and collaborate wherever you are. For Free. Google Docs brings your documents to life with smart editing and styling tools to help you easily format text and paragraphs. Choose from hundreds of fonts, add links, images, and drawings. All for free. Choose from a wide variety of resumes, reports, and other pre-made documents — all designed to make your work that much better, and your life that much easier. Access, create, and edit your documents wherever you go — from your phone, tablet, or computer — even when there's no connection. All your changes are automatically saved as you type. You can even use revision history to see old versions of the same document, sorted by date and who made the change. -
50
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.
