Alternatives to Fusion eClinical Suite

Medrio's Electronic Data Capture (EDC) platform and complimenting eClinical solutions such as ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have been trusted by major pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic companies since 2005. We are known for our easy-to-use solutions, delivering speed and simplicity to clinical trials of all phases, sizes, and complexities. Medrio users can build their databases in an average of 2.8 weeks with no programming required, make mid-study changes with just a few clicks of a mouse, and much more. From bolt-on capabilities to full-service offerings, Medrio offers flexible, modular solutions that give our customers exactly what they need – and none of what they don’t. Our innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.

OpenClinica is a leading provider of clinical data management software solutions. OpenClinica provides powerful tools to ensure that clinical trials are compliant and efficient. OpenClinica Enterprise, OpenClinica Participate and OpenClinica Randomize are the core products.

Streamline your clinical studies with Clinvigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us for thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The Clinvigilant eClinical suite includes: EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. Every interaction and data exchange creates Audit Trails, which provide compliant real-time data visibility across all relevant roles. Our products are modular, highly customizable, and available on the web, iPad, and Mobile App for both Android and iOS. We also support Patient's Own Device (BYOD) and interface with Devices and Wearables. Clinvigilant💊, your one-stop🌐solutions provider for clinical trials☁️ .

Complex eClinical Solutions for EDC/ERT/eCOA significantly speeds up the start and completion of clinical trials (up to 5 days), reduces costs (up to 80% for monitoring), and increases capitalization and attractiveness (recognized by 89% customers). 96% of data science specialists say it increases the knowledge and advancements of Data Management and Data Science professionals. 94% of investigators love interfaces' usability. Strong internal competence in Data Management 365 is an important part of the Data Management 365 policy. This allows us to not only better understand the challenges faced by Data Managers and improve the MainEDC™, but also to transfer technology and best practices to our clients.

Mosio allows research teams to improve subject adhesion, communications, data collection, and communication on mobile's most popular channel, text messaging. Our software helps research teams communicate more efficiently with participants by delivering interactive elements to mobile phones and messaging automation. WHO CAN WE HELP? + Clinical Trial Sponsors (Pharma & Biotech) + Cancer Centers and Clinical Research Organizations + NIH-Funded Studies + Public Health Agencies + Clinical Trial Managers/Directors and Clinical Operations Managers/Directors. Clinical Project Managers. Principal Investigators. Clinical Research (Study). Coordinators. All research staff who regularly communicate with study participants. BENEFITS + Interactive medication reminders and medication compliance alerts + Automate data collection. + Increase engagement and adherence. + Get SMS appointment reminders to fix your no-show problem. + Increase retention with automated check ins

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.

TrialStat, in comparison to other EDC tools on the market such as MediData, DataTrack and Omnicomm, is the most comprehensive suite of study management tools. It can seamlessly connect to external data sources like EMR, wearables and other clinical and nonclinical data and information sources. TrialStat is a fully integrated platform that can be used for all types and phases of trials. Our multi-tenant, single-sign-on EDC suite includes modules to randomize, adjudicate, code, safety, patient diaries/ePRO and Vendor Neutral Imaging Archive. It also has a robust Reporting and Analytics Portal and custom Machine Learning programmes. TrialStat focuses on data analytics and provides real-time reporting, data extractions on demand and analytics across a single study or a program. This gives all stakeholders timely, relevant, customized insight into all aspects and highlights areas of risk or potential delays.

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.

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

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.

DFnet, a healthcare technology company, provides eClinical services, including electronic data capture, eSource and data management services. Our services offer greater flexibility, better data quality, as well as greater efficiency for clinical trials around the world. Collect data from any source, including paper crfs, EDC, other electronic sources, online/offline tablet, and ePRO entries. Install in your secure premises or let us host it in our secure cloud environment. Advanced optical recognition reduces the time required to perform SDV and RBM processes. For multi-center studies with maximum flexibility. Web-based data collection from any source is instantaneously available in a central real-time platform.

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.

Mednet is an eClinical technology company that specializes in healthcare solutions for the global life science community. Mednet's flexible, EDC-centric eClinical platform increases the efficiency of clinical research of all sizes. Mednet's comprehensive solution suite provides all the tools necessary to create and manage clinical research. It can also adapt to changing demands and requirements. Mednet has been trusted by CROs in every sector of the pharmaceutical, medical device, and biotechnology industries for almost 20 years. They provide the expertise, reliability, and innovation that they need to succeed. Mednetsolutions.com has more information.

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.

EvidentIQ's eCOA optimizes real-time, direct from-patient data collection. It offers a simple interface that provides advanced patient assessments to improve the patient experience and data quality. Customers can either benefit from an entire eCOA package, or choose the elements that meet their specific needs to create value. Get a demo from our experts to see how we can help you improve your study ROI. EvidentIQ's eCOA brings together data science and technology. Customers can either benefit from an entire eCOA package that covers all aspects of the process or add value by choosing elements that meet specific requirements. The solution can be used independently of any specific eClinical technologies, such as EDC systems. However, it can be integrated into any existing eClinical software. It has been created to collect any patient/clinician/observer reported outcome data in a streamlined, compliant and efficient way.

DSG, Inc., a global leader in eClinical, offers a complete suite of innovative technology solutions as well as data management services to the global clinical research community. DSG's eClinical platform offers a competitive advantage and on-time delivery. DSG solutions have been used in thousands clinical trials across the globe using our award-winning eCaseLink™, platform and eCaseLinkDesign for enterprise licensing. The company was founded in 1992 and is proud to have been awarded the SCDM Data Driven Innovation Award.

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

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.

Jeeva's patent-pending modular system is built on the most powerful cloud platform. One login from any browser-enabled device can be used to remotely screen patients, educate, enroll, send SMS, email and generate evidence including electronic patient-reported outcomes. They are tired of waiting for patient recruitment and retention to happen. It is crucial to provide sufficient evidence of safety and efficacy for investigational new medicines in order to receive regulatory agency approval. Jeeva is a great tool for saving time and money for patients, biopharma sponsors, and long-term follow up studies for gene therapy.

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

All-in-one solution for clinical trials using diamond SaaS. Data MATRIX has been working with clinical data since 2009. We analyze data and create documents that can be accepted by the Russian Ministry of Health and FDA. Our products automate clinical trials and allow users to monitor and manage the progress of their projects online. To ensure that the project runs smoothly, we adjust and validate the software before it starts. Our team has completed 180 projects for pharmaceutical and biotech firms and CROs. Six of the 10 top Big Pharma companies have seen their R&D costs drop by 15% using Data MATRIX products. Our employees are proud members of professional groups that include clinical data specialists (CDISC), medical writers (EMWA and AMWA), and data managers (ACDM.SCDM).

Zelta is a cloud-powered platform for unified clinical data management and acquisition, designed to streamline and enhance clinical trial processes. Its modular architecture adapts to the unique demands of each study, enabling faster and more efficient outcomes. With capabilities such as electronic data capture, clinical operations management—including randomization and trial supply tracking—clinical trial management, and electronic trial master file functionality, Zelta supports comprehensive study oversight. It also enhances patient and provider engagement with electronic clinical outcome assessments and e-consent solutions. Built for studies across all phases, therapeutic areas, and global regions, Zelta offers an intuitive user experience with secure single sign-on access from anywhere. Its flexible and scalable design allows for seamless customization and integration with both native and third-party technologies, ensuring adaptability to diverse research needs.

You can jump-start your project with one of our applications. Are you unable to find the information you are looking for? Our intuitive visual designer allows you to create a new app. You can easily create your forms, build workflows, and design your app using our intuitive visual designer. No coding required! Drag-and-drop interface and intuitive visual designer allow you to create your study. The type of study you are doing and the data you want to collect will determine the structure of your database. You can then aggregate and review your data using specialized screens. You can check for discrepancies, manage incomplete forms and track follow-ups. Rediscover your database, and organize it according to the criteria that you choose. Use saved datasets to create filters in natural language for data analysis, workflow planning, patient management, and reporting.

Calyx understands that data is key to the success of any clinical development program. Your electronic data collection (EDC), system is crucial to your success. Calyx EDC is used in more than 2,600 clinical trials around the world. It streamlines data collection and reporting through one platform. Don't give your sensitive data to anyone. We can help you make your program a success with Calyx. Calyx EDC allows you to plan, design, and carry out studies of any complexity. Calyx EDC helps you keep your trial on track with features that reduce costs, improve site visibility and drive efficiency.

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

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.

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.

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.

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

Signant Health, a global evidence generation company, helps modernize clinical trial by meeting patients where the are and reimagining how to prove. They offer a comprehensive range of clinical technology solutions including electronic Clinical Outcome Assessments, Electronic Data Capture, electronic clinician ratings and a unified eClinical Platform. Their patient engagement tools include a patient app, eConsent and telemedicine capabilities. Signant Health offers clinical data and analytics, including COA data analytics, data aggregation, and intelligence. They have over 30 years' experience and have supported thousands trials and contributed hundreds of drug approvals. This makes them a trusted partner to sponsors and CROs who are looking to deliver high-quality information for trial decisions and regulatory filings.

Secure and user friendly cloud-based EDC platform for managing clinical trials and studies of all sizes and complexities: ePRO, eConsent, eCOA, eSource, PROMs, PREMs, functional health assessments and participant education/engagement.

TrialKit is a cloud-based platform available via both a web and native mobile app, enabling end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharma companies of all sizes. Design and deploy validated studies in days not weeks using our intuitive study builder that requires no programming. Thousands of global users have leveraged the flexibility of TrialKit to deploy over 8,000 studies across all phases of development.

A platform that integrates EDC, eConsent and ePRO for efficient clinical trials. Replior is a company that provides software for clinical trials. Trial Online is a suite of software that allows investigators, participants, and wearables to collect and manage data in an efficient and easy way. Trial Online supports decentralized clinical trial (DCT) by allowing trials to operate with remote visits, site visits, or as a hybrid. Our journey began 20 years ago when we were asked to create an online CRF service by one of the largest pharma companies in the world. Back then, we were an IT operations provider for pharma. This was the beginning of software that allows for data collection in clinical trials. Today, we offer a complete suite of data collection software services. Our IT operation is handled by our certified sister company Complior.

Dacima Clinical Suite, the most advanced web-based solution, combines electronic data capture (EDC), medical data management software (CDMS) and clinical trial management software into one platform. Dacima Clinical Suite is designed for clinical trials, epidemiological studies, web randomization, ePRO, surveys, and patient registers. Dacima Clinical Suite comprises three core modules: the Manager (Administrator), Designer Module, and the Data Entry Module.

eCOA, digital technologies, and other digital technologies, are the future of clinical and research. They bridge the gap between traditional and forward-looking, patient focused development. YPrime's eCOA services are not only high-quality patient data but also provide a better user experience across investigator sites, patients, and sponsors. YPrime uses an agile software development approach to quickly configure and customize functions to meet the needs of each study. This takes between 8-12 weeks. Clients have the opportunity to view the system at various stages of design and development before it goes live. Our pre-validated and configurable authoring environment makes it easy to set up start-up times and make post-production changes such as protocol amendments.

Data management is crucial to the success and efficiency of your clinical research. Despite being complex, Quanta View, an e-CRF, makes it possible to control the processing of your data. Quanta View includes elements such as monitoring, follow up of inclusions, and project management. The application will be there to help you in all aspects of your clinical research. It is accessible via the internet and responsive. It adapts to all media (tablet, laptop, etc.). Quanta view is designed for the pharmaceutical, medical device, and cosmetic industries.

AI-enabled and Integrated Electronic Data Capture Software Clinion EDC is the most Integrated Electronic Data Capture System in the Industry making your clinical trials faster and better. Our Electronic Data Capture Software accelerates the speed of your clinical trial by reducing deployment time, capturing data faster, timely study close-out, and early data lock – all in a cost-effective manner providing the highest data quality, integrity, and security. Clinion EDC Software integrates all the functionalities you need into one platform, from study setup to data management and reporting.

A comprehensive, proven and standardized clinical trial management system, developed in collaboration with top academic medical centers and cancer centres, will give you visibility into all aspects your research operations. To ensure consistency across different teams and systems, centralize billing designation information. You can improve your budgeting, route charges correctly, and audit/monitoring billing compliance more accurately. With a standard system developed in collaboration with top research institutions, you can gain visibility and insight into all aspects clinical research. Integrate OnCore into your existing EMR, including turnkey interfaces to Epic and Cerner, in order to improve patient safety, reduce duplicate entry, improve billing compliance, and increase operational efficiency.

Mahalo Health, a unified platform for digital health, is designed to accelerate the creation of patient-centric digital applications and clinical trials. By offering prebuilt modules. Mahalo allows for rapid deployment of white label apps tailored to specific therapeutic fields. The platform's unified capabilities include a predictive engine for disease diagnosis and prediction, a behavior-change engine to encourage positive patient actions, as well as a notification engine that can send timely communications via SMS, email, or push. Mahalo adheres with standards such as HIPAA, GCP ISO27001 and GDPR to ensure robust security and compliance. Its services cover a wide range of therapeutic areas including diabetes, cognitive and cardiovascular health, musculoskeletal disorders (MSK), mental health, oncology and rare diseases.

AI-powered medical image processing meets advanced clinical data automation. UNITY, available as a web-based SaaS solution or on-premises solution, is trusted by major medical equipment manufacturers and hospitals around the world to collect complete, compliant, and consistent data. The integrated modules for PROM and eCRF streamline key data collection to enable faster, more cost-efficient trials. RAYLYTIC’s Imaging Core Lab has decades of experience in high-precision, automated evaluation of musculoskeletal device performance and morphology in spine, hip and knee.

AnjuEPS, a leading eSource solution and site automation tool, is designed to streamline early phase clinical trials from volunteer recruitment through to study submission. It ensures data quality by directly capturing information from medical devices, and applying real-time editing checks. This eliminates the need for paper sources. AnjuEPS provides critical safety monitoring via real-time alerts for out-of-range data and historical safety data insights. This allows better volunteer safety management. The platform's intuitive Design & Build module speeds up study builds and reduces time and costs. The platform's key features include ad-hoc reporting, sample tracking, and fully integrated modules for recruitment and pharmacy management. AnjuEPS ensures that clinical data are collected with accuracy, efficiency, and transparency.

The Interactive Response Technology (IRT), systems of today are becoming more complex. Flexible and configurable IRT is important - IRT data can be used as the source of record to recruit, drop-out rates in clinical trials, patient visits, or any other vital data. You want a platform that is user-friendly, mobile-ready and comprehensive. It should also be embedded in quality, flexibility, and expertise. In today's risk-based eClinical environment, comfort is combined with complex therapeutic expertise. We empower clinical trials to deliver positive patient outcomes by combining the right technology, subject matter knowledge and a commitment to service. Clients have control over their Randomization and Trial Supply Management processes (RTSM) thanks to deep clinical and supply chain knowledge. Our innovative tools drive exceptional levels of quality control, site efficiency, and patient compliance. Our IRT platform is able to meet the needs for almost any study and allows fully validated deployment in as little time as 30 days.

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

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.

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

BSI CTMS impresses with its innovative interface and intelligent visualization of data. Our clinical trial management software is more than just an attractive interface. It includes functions that assist pharma, biotech, and diagnostics sponsors as well as CROs and academics (SMOs) in their daily lives for managing clinical trials in a targeted manner. BSI CTMS continues to be developed based on market needs and in close collaboration. BSI CTMS is unique because it offers CTMS, eTMF and Study Startup functionality in one integrated platform. Excel and other standalone solutions are overrated.

Omda MedSciNet improves the quality, utility and management of medical information from collection to analysis. This secure, standardized software allows clinical researchers and other professionals from medicine and academia to easily gather and analyze well managed medical data. The Omda team is specialized in designing and building clinical studies and custom database applications for medical research. The Omda MedSciNet platform is a highly customizable, feature-rich and reliable online environment that hosts and manages sophisticated study and trial systems. Omda MedSciNet is a proven platform that has hosted studies and clinical trial systems of all sizes and scopes for over 20 years. The standard implementation includes all the components needed to establish fully functional clinical trials or studies.

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

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

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