Alternatives to Clienvo eTMF
Compare Clienvo eTMF alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Clienvo eTMF in 2026. Compare features, ratings, user reviews, pricing, and more from Clienvo eTMF competitors and alternatives in order to make an informed decision for your business.
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IQVIA
IQVIA
Thousands of organizations around the world trust IQVIA to speed drug development, ensure product quality and safety, improve commercial effectiveness, get the right treatments to patients, improve access to and delivery of healthcare, and ultimately drive better health outcomes. Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster. With a foundation in data, advanced analytics, and expert insight, IQVIA brings specialized capabilities to customers across the healthcare ecosystem. Read and watch the latest from IQVIA data scientists, doctors, researchers, and other subject matter experts on the topics that matter to you. From industry trends to how we are applying our capabilities to help, you can find it here. -
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Castor EDC
Castor
Castor is a leading platform for clinical data management, offering advanced solutions for electronic data capture (EDC), patient-reported outcomes (ePRO), and eConsent. Designed to streamline clinical trials, Castor enables researchers to efficiently collect and manage data from multiple sources in a compliant, user-friendly environment. The platform also supports decentralized trials (DCTs), providing tools for remote patient recruitment, monitoring, and real-time data analysis. Castor is trusted by over 50,000 users globally, helping clinical research teams accelerate trials while ensuring high-quality data and regulatory compliance.Starting Price: $100.00/year -
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Clinion eTMF
Clinion
Clinion's electronic trial master file (eTMF) system has unique features that simplify storage, access, and management. The simple user interface makes it the go-to tool for clinical trial document management. -
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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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SimpleTrials
SimpleTrials
SimpleTrials is an on-demand, subscription-based Clinical Trial Management System (CTMS) designed for sponsors, Contract Research Organizations (CROs), and investigative sites. It offers a comprehensive suite of tools to effectively plan, manage, and track clinical study portfolios, including features such as site startup and subject tracking, document management with integrated electronic Trial Master File (eTMF), real-time study analytics, calendar and monitoring, custom fields and trackers, ad-hoc reporting, planning and milestones, site contracts and payments, and electronic visit reports. It supports compliance with 21 CFR Part 11 and provides a secure, validated environment for clinical trial data. Users can customize tracking views, integrate with various Electronic Data Capture (EDC) systems, and utilize built-in templates for consistent document management.Starting Price: $849 per month -
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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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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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GRAVITY
ASSAY Clinical Research
In clinical research, being organized is a prerequisite of success. Bringing the right resources to bear at the right time is a challenge. This is particularly applicable for document management for a clinical trial. GRAVITY is your long-time solution for site file and trial master file management. We have converted both files into easy to manage, co-ordinated electronic format. This integrated package facilitates logical and convenient document management. Being an integrated eTMF and eISF system, GRAVITY becomes a complete cloud-based electronic DMS, Serving as a window for sponsors, CROs, and Sites. However, GRAVITY can also be deployed and utilized for each individual entity alone. when a site is selected for conducting clinical trial, Documents start to flow in, however, the initial pack of essential documents require maintenance. GRAVITY incorporates a unique features of overseeing the essential document management and alerting the users of expiring documentation. -
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LifeSphere eTMF
ArisGlobal
LifeSphere eTMF is your clinical trial’s single source of truth. Discover a versatile solution that streamlines inspections, ensures compliance, and saves your organization time and effort. Built as the first system to support the TMF reference model, LifeSphere eTMF aligns Clinical documentation with regulations and study protocols in one solution. Create and manage a single source of truth for your clinical trial. Ensure trial master file quality, timeliness, and completeness with live collaboration and real-time document sharing. Streamline TMF inspections quickly and efficiently to handle any audit. Maintain compliance with embedded workflows and dashboards that allow easy trial reconstruction. -
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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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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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ImproWise
Core Clinical Services
ImproWise – a 100% web-based, secure, and HIPAA compliant platform designed for end to end Clinical Trial Management (CTMS) and Clinical Data Management (CDMS). ImproWise offers unparalleled flexibility, speed, and security, combining CTMS, CDMS, EDC, CTBM, CTPM, eTMF, ePRO, and RBACS functionalities. ImproWise is crafted to meet the needs of every stakeholder in clinical trials. From sponsors and investigators to data managers, data entry specialists, site staff, and regulatory affairs professionals, our platform ensures seamless collaboration and efficiency. -
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Cloudbyz eTMF
Cloudbyz
Cloudbyz eTMF solution offers a cloud-based repository of all clinical trial documents including files, images, information, etc. Digitally store, manage, and share all clinical trial-related documents with a centralized overview. Manage essential trial documents, stay inspection ready, and enable real-time visibility for CROs, sponsors, monitors, and other stakeholders in a clinical trial. Cloudbyz eTMF is built on the cloud, enabling Sponsors, CROs, and Sites to manage their trial documents with the highest levels of efficiency and integrity. The solution benefits are listed below - 1. Secure, reliable & scalable 2. Compliant & inspection ready 3. Flexible & easy to use 4. Real-time visibility of TMF completeness 5. Collaboration with Site/ Sponsor/CRO -
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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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Medidata
Dassault Systèmes
The Medidata Clinical Cloud is our cutting-edge platform that transforms the clinical trial experience for patients, sponsors, CROs, and research sites. As the only unified technology platform dedicated to clinical research, the Medidata clinical cloud addresses the holistic research process from start to finish. Our platform helps life science and medical device organizations cut development costs, mitigate risks, and deliver treatments and devices to market faster. No matter which products you choose for your clinical trial program, you will have access to the power of the Medidata Clinical Cloud. At Medidata, we’re leading the digital transformation of clinical research. Powered by artificial intelligence, machine learning and advanced analytics, our platform brings researchers, study managers, investigators, and patients together to accelerate research. Obtain regulatory-compliant, patient-friendly electronic informed consent for clinical trials. -
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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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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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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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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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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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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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DF mSafety AI
Datafoundry
DF mSafety AI is a cloud-based safety platform that leverages AI/ML and automation to enhance efficiency and user experience in safety case management and signal detection for drugs, cosmetics, vaccines, nutraceuticals, and medical devices. Built on Datafoundry's loud platform, DF Safety 4.0, it supports scalable and secure AI/ML-driven safety case and signal management, with pre-built connectors to enterprise systems, adhering to regulatory requirements and industry standards. Key features include multi-source case intake options, automated triage rule configuration, seriousness prediction, causality assessment, expectedness and listedness assessment, auto narrative generation, custom report generation, literature monitoring for safety, signal and risk management, case compliance alerts, integrated MedDRA and WHO-DD browsers, enhanced E2B R2 & R3 compliance, and an e-submissions gateway. -
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Zelta
Merative
Zelta is a cloud-based unified clinical data management and acquisition platform with adaptable modules that can be tailored to meet the unique needs of your clinical trials program and accelerate outcomes. It offers features such as electronic data capture, clinical operations tools like randomization and trial supply management, clinical trial management system, electronic trial master file, and patient and provider engagement solutions including electronic clinical outcome assessments and electronic consent. Zelta is designed to manage clinical studies across all phases, therapeutic areas, and regions, providing a user-friendly interface and seamless access through single sign-on from anywhere in the world. The platform emphasizes flexibility and scalability, allowing for customization to align with specific study goals and the integration of solutions from both Zelta and other technology vendors. -
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Flex Databases
Flex Databases
Document management and ensures regulatory compliance in clinical trials. By integrating AI and a unique "co-pilot" feature, our platform boosts efficiency while maintaining human oversight. Automated Filing with AI The AI assistant automates document classification and metadata assignment, reducing manual effort. Co-Pilot for Human Control The "co-pilot" feature allows users to set confidence levels for AI classification. Documents below the threshold are flagged for review, and users can adjust classifications, helping the AI improve. Key Benefits: Efficiency: AI automates tasks, allowing more focus on critical activities. Accuracy: AI and co-pilot oversight ensure data integrity and compliance. User-Friendly: An intuitive interface simplifies document management. Continuous Learning: AI improves accuracy with ongoing user feedback.Starting Price: $1300.00 -
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eTMF Connect
Montrium
Introducing the new eTMF Connect. Simplicity Without Compromise. We’ve re-engineered eTMF Connect for a faster, more scalable and higher performing eTMF solution for today and tomorrow’s clinical trial environment. Improved Data Visualizations & Reporting Views. Montrium now offers a range of new data visualization and reporting tools embedded into eTMF Connect, providing more powerful business intelligence applications. With functionality that provides better insight across all of your studies, project teams and clinical operations managers can have increased visibility on TMF completeness, quality, and timeliness. Together, these improvements will elevate your TMF strategy across clinical programs. No clinical trial is the same, and the subtle nuances and regional differences add layers and layers of complexity that can keep even the most experienced TMF professional up at night. Your eTMF platform needs to be flexible enough to manage these differences and nuances. -
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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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Signant Health
Signant Health
Signant Health is a global evidence-generation company that helps modernize clinical trials by meeting patients where they are and reimagining the path to proof. They offer comprehensive clinical technology solutions, including electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician ratings, and a unified eClinical platform. Their patient engagement tools encompass a patient engagement app, eConsent, and telemedicine capabilities. Signant Health also provides clinical data and analytics services, such as COA data analytics and data aggregation and intelligence. With over 30 years of experience, they have supported thousands of trials and contributed to hundreds of drug approvals, making them a trusted partner for sponsors and CROs aiming to deliver high-quality data for trial decisions and regulatory submissions. -
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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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Evidex
Advera Health Analytics
Automated surveillance of any data source, fully integrated with a GVP IX compliant signal management platform. GVP-IX compliant signal management platform integrated within Evidex and ready to use off-the-shelf. Modernize and audit-proof your management processes without having to move back and forth between platforms and services. Unlock the value of your safety data. When you automate signal detection and management, you can focus not just on regulatory requirements, but on driving value for your organization. Identify safety signals from traditional sources like ICSR databases, FDA Adverse Event Reporting System (FAERS), VigiBase and clinical trial data. Include new data sources such as claims, EHR, and other unstructured data. Bring these pools of information together seamlessly to enhance signaling algorithms, make validations and assessment more efficient, and provide faster answers to drug safety questions. -
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cubeCTMS
CRScube
cubeCTMS is a comprehensive clinical-trial management system designed to provide end-to-end oversight of trials, from site and investigator tracking, enrollment management and visit scheduling through budget and contract workflows, milestone reporting and document control. It centralizes study operations and automates key processes so sponsors, CROs and study teams can monitor progress in real time, manage tasks across multiple studies, improve site communications and mitigate risk. With built-in dashboards, alerts and audit-ready logging, cubeCTMS supports regulatory compliance (including FDA 21 CFR Part 11 readiness) and enables stakeholders to manage trial timelines, resources and performance from one platform. The system integrates with other CRScube modules (such as EDC, eTMF, pharmacy/RTSM) to provide a unified ecosystem that reduces duplication, improves data flow and supports adaptive workflows during amendments or global roll-outs. -
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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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DrugCard
DrugCard
DrugCard is an AI-enabled data intelligence platform designed to streamline pharmacovigilance processes by automating local literature screening. The platform supports over 100 languages and monitors more than 1,000 local medical journals across 55+ countries, ensuring continuous, regular, and transparent monitoring. By automating routine tasks, DrugCard enables Contract Research Organizations (CROs) to manage more pharmacovigilance projects and improve screening results, Marketing Authorization Holders (MAHs) to conduct in-house literature screening more effectively, and freelancers to save up to 70% of their time for other value-adding activities. The platform is designed to be scalable to new markets, cost-effective, and compliant with regulatory requirements, providing a comprehensive solution for drug safety departments. -
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Phoenix CTMS
Phoenix CTMS
Phoenix CTMS is an integrated, web-based platform combining Patient Recruitment System (PRS), Clinical Trial Management System (CTMS), and Clinical Data Management System (CDMS) functionalities into one modular, free-to-use application. Designed to meet the operational and regulatory needs of clinical research, it supports academic institutions, CROs, and hospitals conducting trials of any phase. The system offers private, encrypted subject registries to safeguard personally identifiable information and complies with EU-GDPR requirements. Phoenix CTMS includes advanced electronic data capture (EDC) features with unlimited JavaScript form scripting and support for large electronic case report forms (eCRFs). It enables managing multiple trials simultaneously with tools for site staff and resource organization. Developed collaboratively with the Medical University of Graz, Phoenix CTMS is a secure, open source alternative to traditional EDC packages.Starting Price: $1 one-time payment -
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Jeeva eClinical Cloud
Jeeva Informatics Solutions
Jeeva's patent-pending modular solution is designed from the ground up on the most powerful cloud platform with one login from any browser-enabled mobile device for remote patient screening, education, enrollment, electronic informed consent, bi-directional communications via video calling, telemedicine, SMS, email, and evidence generation including electronic patient-reported outcomes and clinical outcomes assessments, with a modern user experience. Delays in patient recruitment & retention are keeping them up at night. Generating enough evidence of safety and efficacy of investigational new medicines is critical to get timely approval from regulatory agencies. Whether you are a patient group setting up a registry or natural history study, or a biopharma sponsor of a clinical trial, or a long-term follow-up study for gene therapy, Jeeva can save you time, and money while improving user experience for study team and trial participants.Starting Price: $100/mo/user -
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Zapclinica
Zapclinica
Manage your clinical trial in one platform. Zapclinica is an eClinical suite designed to manage and conduct every aspect of your decentralized clinical trial - hybrid or virtual. Automate complex processes, identify outliers, optimize resources, improve decision making and collaboration between sponsors, CROs, and sites. Zapclinica reduces the time and costs to run a successful clinical trial. Manage your clinical trial in one platform. Zapclinica is an eClinical suite designed to manage and conduct every aspect of your decentralized clinical trial - hybrid or virtual. Automate complex processes, identify outliers, optimize resources, improve decision making and collaboration between sponsors, CROs, and sites. Zapclinica reduces the time and costs to run a successful clinical trial. Cover all aspects of your study with one platform. No extra vendors, no extra third-party, choose the app you need in a single environment, including EDC, ETMF, Payments, Logistics, and many more. -
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LifeSphere CTMS
ArisGlobal
Complete control. Full visibility. LifeSphere CTMS is an easy-to-use trial management solution that helps clinical operations teams accelerate timelines, stay organized, and reduce complexity. Reduce study timelines with a modern, easy-to-use cloud application that streamlines study management and automates key activities across the trial lifecycle. Navigate complexity with a simple, yet powerful trial management application that provides full oversight of trial activities to keep study teams aligned and on time. Streamline your clinical environment with a turn-key platform for operations that includes payments and monitoring and delivers a seamless connection with LifeSphere eTMF. Create seamless connections with TMF Reference Model Exchange Mechanism Standard compliance for seamless, cross-platform document sharing. -
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Clinical Research IO
Clinical Research IO
The industry’s leading eSource, CTMS, and eRegulatory software for clinical trial sites. Capture source data seamlessly and in real-time with CRIO’s best-in-class electronic source. You’ll eliminate up to 90% of your paper and improve data quality by 80%. Take control of your operations with CRIO’s intuitive Clinical Trial Management System. Schedule patients, track financials, streamline recruiting, and more. Introducing electronic regulatory binders fit for the 21st century, which includes the first-ever electronic delegation log — all 21 CFR Part 11 compliant. For clinical trial sponsors: conduct 100% remote monitoring of your sites’ source data and regulatory documents in a secure, online portal. Join Our Network of 500+ Clinical Research Sites From Around The World. Our mission is to help you grow your business. We do that by streamlining your site’s operations, so that your studies don’t stop just because you aren’t in clinic. -
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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. -
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Datatrial Nucleus
Datatrial
One Platform to Research, Document, and Collate your Clinical Data. Simplify your research data with the Nucleus platform. A single platform to store your study documentation, clinical datasets, submission data and compliant media. Nucleus Documents enables document management and version control for your quality documentation and media. Control, manage, and share company content with ease. Collate and control your electronic trial master file documents with ease using our centralized regulatory document management solution. Nucleus Coding enables dictionary term coding against both MedDRA and WHODrug dictionaries, either in our standalone application, or integrated into your data capture system. -
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ClinSoft
Innovate Research
Innovate’s End-To-End Clinical Data Management Services. Our clinical data management processes, expertise and technology are developed to make each step of your clinical trial data management process more accurate and efficient for Phase I-IV in wide range of therapeutic areas. Our CDM Team Is Well-Versed With Current Good Clinical Data Management Practices (cGCDMP) International conference on harmonization Good Clinical Practices (ICH-GCP) 21 CFR Part 11 Compliance Health Insurance Portability and Accountability Act (HIPAA) Requirements Applicable Regulatory Guidelines SAS datasets SAS XPORT transport files EDC Helpdesk Support 24/7 On-Site and Off-Site Clinical Data Management Services Electronic Data integration and transfer Quality Control Activities Medical Dictionary for Regulatory Activities (MedDRA) Serious Adverse Event (SAE) Reconciliation Clinical Database Transfers Clinical Database Lock paper Case Report Form (pCRF) and electronic Case Report Form. -
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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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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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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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BSI CTMS
BSI Business Systems Integration AG
BSI CTMS convinces with his trend-setting interface and the intelligent visualization of data. Behind the optics, our clinical trial management software is packed with functions that support pharma, biotech and diagnostics sponsors, as well as CRO and academics (SMO) in their daily world for managing clinical trials in a targeted way. BSI CTMS is being constantly further developed, based on market requirements and in close collaboration with our existing customers. BSI CTMS stands out with its comprehensive functionality, providing CTMS, eTMF, Study Startup and Trial Supply Management RTSM in one integrated unified platform. It’s time to say goodbye to Excel and other stand-alone solutions. You decide if BSI CTMS shall be hosted in the cloud by BSI or on-premise on your IT infrastructure, it is up to you! You can even start in the BSI cloud in order to speed up the project implementation and then later change to on-premise hosting. No vendor locking using BSI CTMS. -
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Clario eCOA
Clario
Unlock better evidence with high-quality ePRO and eClinRO. Electronic Clinical Outcome Assessments, or eCOA, measure how patients feel or function during clinical trials. By capturing clinical data electronically, you can be confident that your patient’s data is high-quality and regulatory-compliant. Put simply, eCOA avoids the quality and time issues associated with paper diaries, such as illegible answers, transcription errors and inconsistent or conflicting data. Also, the FDA recommends ePRO. Patient-reported outcomes, patients report on their health via questionnaires or assessments. Examples include quality of life or activity outcomes. The clinician reported outcomes. Health outcomes are reported by a clinician. An example may include a physical examination such as PASI. Performance outcomes are measures from specific tasks the patient is asked to perform. An example might be performing a timed task. -
46
oomnia
Wemedoo AG
oomnia is a real-time SaaS platform that unifies all essential clinical trial tools-EDC, RTSM, CTMS, eTMF, eCOA, ePRO, and eConsent-into one cohesive system. With single sign-on, users save up to 75% of time spent navigating between systems. Its multi-tenant design allows stakeholders to manage multiple trials on a single instance and gain oversight of entire portfolios. No coding is required due to intuitive drag-and-drop features. oomnia is fully interoperable, eliminating integration issues, and offers role-based access with a user-friendly interface customizable by language and notifications. Real-time reporting, seamless randomization, and complete audit logs enhance efficiency and data accuracy. The platform complies with 21 CFR Part 11, EU Annex 11, and CDISC standards. ISO 27001 and ISO 9001 certified and FDA/Swissmedic inspected, oomnia enables up to 50% time and cost savings through streamlined, intelligent trial management. -
47
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. -
48
Judi
Judi
Judi is a cloud-based clinical-trial collaboration platform built to simplify, secure, and streamline complex workflows across sponsors, CROs, trial sites, and partners. It supports a full range of trial functions, from endpoint/event adjudication, central eligibility review, data-safety-monitoring, remote monitoring, medical imaging, and site/user qualification, to fully custom workflows (Judi Flex). Judi replaces manual processes, spreadsheets, untracked emails, or siloed file-sharing tools with a unified, compliant workspace: every document, communication, image, query, and decision goes through secure, traceable pipelines. Built-in features include role-based permissions, audit trails, real-time chat, query management, dashboards and worklists, flexible document submission and review, eCRFs with edit checks, and reporting tools, making trial data collection, review, and reporting far more efficient and less error-prone. -
49
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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Chronicles CTMS
Chronicles Research Team
Full cycle product for Research and Development teams in Pharmaceutical Industry. The product includes Electronic Trial Master File, Trial Management, Electronic Document Management with eSignature support. That is suitable for regulated areas as it is fully compliant with 21CFR Part 11 requirements. We develop and support systems from the very begining to the ready-to-use product using modern agile methodology and feedback given by clients. Satisfaction of customers needs is our main concern. We provide automation services of quality management systems starting from SOPs development and training to systems integration and business processes adapation. Our personnel have expertise in GCP, GLP, GCLP and also have been involved in many research organizations' audits and software development. By purchasing the system you get the full package of documents, training and support. So you can focus on your business and delegate us all the technical issues.
