Alternatives to Clinion eTMF
Compare Clinion eTMF alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Clinion eTMF in 2026. Compare features, ratings, user reviews, pricing, and more from Clinion eTMF competitors and alternatives in order to make an informed decision for your business.
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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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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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Clinion CTMS
Clinion
Most Easy-to-Use Clinical Trial Management System (CTMS) đđĽđ˘đ§đ˘đ¨đ§ đđđđ integrates seamlessly with Clinion EDC and Clinion RTSM to provide detailed and faster access to the entire trial process to address all aspects of Clinical trial management from a single platform: investigator sites, patients enrollment, SAEs, deviations, inclusions, visit scheduling, IP management, milestones, finances, custom reports, and on-demand analytics enables you to improve quality, control risk, and reduce costs. Our Clinical Trial Management System allows CROs and Sponsors to monitor the trial progress actively with its advanced dashboard and alert notification system. So youâll never miss a deadline again! What can you expect? Comprehensive CTMS Software Single Source for your entire trial data On-demand Analytics for Risk-Based Management of Clinical Trials Fully Integrated with Clinion EDC and Clinion RTSM 100% web-based and hosted securely on the cloud 21 CFR Part 11 & GD -
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SimpleTrials
SimpleTrials
âSimpleTrials 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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LifeSphere eTMF
ArisGlobal
LifeSphere eTMF is your clinical trialâs 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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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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Clinion eCOA
Clinion
Clinion eCOA enables you to run decentralised clinical trials with patients participating remotely, using eConsent and patient diary for higher compliance Clinion eCOA allows study participants to report their health using their own smartphones, from the comfort of their homes; allowing clinicians to monitor patients in real-time. Clinion eCOA is fully integrated with Clinion EDC and allows trial participants to input daily outcomes directly, eliminating data duplication and transcription errors and providing clinicians with a real-time view of patient progress. The eCOA app supports multilingual forms that simplify patient engagement and generate cleaner data. The decentralised nature of eCOA allows wider and faster patient recruitment. -
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Clinion RTSM
Clinion
Using Interactive Response Technologies (IWRS), Clinion RTSM helps you with efficient patient randomization and clinical trial supply management The Randomization module of the Clinion RTSM Software allows you to implement simple to complex randomization strategies as per protocol specifications, fully integrated with Inventory. Clinion offers one of the most fully integrated EDC/RTSM platforms in the industry, so site users can perform Randomization and drug allotment, including returns and re-allotment, without having to log into two systems or worry about reconciliation Take advantage of our affordable and predictable pricing model to reduce the overall cost of RTSM ownership without sacrificing quality or functionality. Gain more by using our integrated EDC and RTSM modules -
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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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eTMF Connect
Montrium
Introducing the new eTMF Connect. Simplicity Without Compromise. Weâve re-engineered eTMF Connect for a faster, more scalable and higher performing eTMF solution for today and tomorrowâs 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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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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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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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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ImproWise
Core Clinical Services
ImproWise â 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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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. -
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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. Itâs 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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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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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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ClinVigilant
ClinVigilant
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. How simple and user-friendly is it? Ask for a demo to find out! Clinvigilantđ, your one-stop đsolutions provider for âď¸clinical trials. Enquiries > bd (at) clinvigilant.com -
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Astracore Clinical Trials
Astracore
Our clinical trials management system is suitable for virtually any controlled clinical trial, including randomized trials, with a choice of randomization algorithms. Clinical trial software is easily configured for paper CRF (Clinical Report Form) and provides eCRFs (electronic CRF). The software can be configured to capture data in a vast number of forms and techniques, with specific rules as defined by you, to build in integrity and quality checking. The system can be used for direct Electronic Data Capture (EDC), i.e. eCRF, or to print paper CRFs which could consequently be entered into the system. You can also attach images, audio, video, documents (say consent forms) etc., limited only by the amount of storage available. The system is Double Data Entry enabled and has detailed exception reporting. This includes and option to lock records once they have been matched, to prevent any further changes. -
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CTMS Master
Anju Software
Premier clinical trial management system designed specifically to help overcome technical challenges associated with managing clinical trials. CTMS Master improves user accessibility and communication, reduces manual operations, and eliminates redundant data and tasks, allowing a more efficient trial conduct. An integrated Site Visit Report tool with automated workflow eliminates duplicate data entry and facilitates the creation of out-of-the-box Site Visit Reports (SVR). Maintain standard templates for project and site documents, events, milestones, site visit reports and budgets that are tailored as needed for each study. CTMS Master provides 100+ metrics/statistics for clinical study projects, countries and sites as well as 80+ standard reports plus ad hoc reporting capabilities. With CTMS Master, you can define site-specific budgets from a default budget template, track accrued payments and future obligations, define automatic or manual approval of each payment type, and more. -
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Clinion EDC
Clinion
AI-enabled and Integrated Electronic Data Capture (EDC) 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(EDC) Software accelerates the speed of your clinical trial by reducing deployment time, capturing data faster, timely study close-out, and early data lock â 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. What can you expect? - Quick mid-study changes, no need to rely on tech support or take your study offline. - Accelerates data validation and processing by using form rules like edit checks and skip logic. - Support for complex, multi-center studies - Can be integrated with Clinion RTSM, Clinion eCOA, and Clinion CTMS - easy-to-use interface and AI-enabled features -
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Clinical Conductor CTMS
Advarra
Clinical Conductor CTMS is a cutting-edge clinical trial management system (CTMS) designed for hospitals, research sites, asset management companies, site networks, health systems, and contract research organizations (CROs). This cloud-based solution helps make the clinical trial process more efficient, thereby helping research organizations make better business decisions and meet every challenge. Key features include electronic data capture, study planning, enrollment management, document management, recruiting management, and more. -
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Healthcare solutions from VACAVA reduce the complexity and cost of clinical trial regulatory document management. Each time documents move through a manual workflow, it introduces the opportunity for delays and lost information. VACAVA solutions help you streamline regulatory processes by storing profiles, forms and documents in a single easy-to-access online location. Documents seamlessly move through your workflow with approvals captured electronically (21 CFR Part 11 compliant). Easy-to-read dashboards enable efficient management. VACAVAâs Regulatory Document Management System was built in collaboration with a major clinical trial research base to simplify operations and radically increase efficiency. VACAVAâs Regulatory Document Management System is surprisingly affordable and can be customized to meet your unique needs. VACAVAâs solutions are flexible, scalable, and delivered via the cloud so you never have to worry about managing servers, security, and backups.
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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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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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Clinical Research IO
Clinical Research IO
The industryâs leading eSource, CTMS, and eRegulatory software for clinical trial sites. Capture source data seamlessly and in real-time with CRIOâs best-in-class electronic source. Youâll eliminate up to 90% of your paper and improve data quality by 80%. Take control of your operations with CRIOâs 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 â all 21 CFR Part 11 compliant. For clinical trial sponsors: conduct 100% remote monitoring of your sitesâ 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 siteâs operations, so that your studies donât stop just because you arenât in clinic. -
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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. -
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ClinAccess
MAJARO InfoSystems
ClinAccess⢠5.1 is the next generation of our industry leading Clinical Data Management System based entirely on SASÂŽ 9. It leads the way in simplifying clinical data management, clinical trial analysis and preparation of electronic submissions. Having your data keyed directly into SASÂŽ data sets enhances your staffâs productivity by eliminating the time spent transfering data from Oracle/SQL into SAS. ClinAccess⢠is designed expressly for ease-of-use study definition, data entry and management with features to monitor the progress and quality of ongoing clinical trials. Whether for review, analysis, or FDA submission, your data is always in SASÂŽand ready for analysis. The database structure is designed to support and accelerate statistical analysis and reporting. The result is less time and effort for data analysis and a shorter time to market. For reliability, auditing and security, there is no better solution than ClinAccessâ˘. -
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Cloudbyz CTMS
Cloudbyz
Cloudbyz CTMS is a cloud-based trial management platform natively built on Salesforce Cloud. It is aimed at sponsors, clinical research organizations (CRO), and clinical sites for managing end-to-end clinical trial operations. Designed for clinical research, it expedites implementation and drives user adoption. Cloudbyz CTMS comes with an intuitive, straightforward design that allows for quick deployment. Boasting a rich set of features, Cloudbyz CTMS makes it easy for users to manage all aspects of clinical trials, including sites, enrolment, documents, events, milestones, site visit reports, finances, inventory, etc. Cloudbyz provides end-to-end management of the clinical trial lifecycle, including study setup, site management, study projections, monitoring, and financial management. With Cloudbyz, you can optimize your study planning, accelerate patient recruitment, and increase trial quality, while reducing costs and minimizing risk. -
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Medilake
CLUPEA
Introducing Medilake: Your Premier Solution for Comprehensive Clinical and Non-Clinical Trial Data Management We are delighted to introduce Medilake, an innovative and versatile platform that excels in the seamless management of both clinical trial and non-clinical trial data. In an era where data is the lifeblood of healthcare and research, Medilake emerges as the ultimate choice for simplifying, optimizing, and enhancing data management processes across the spectrum of clinical and non-clinical trials. * Why Choose Medilake for Clinical and Non-Clinical Trial Data Management? - Unified Data Hub - Streamlined Collaboration - Data Integrity and Security - Advanced Analytics - And Scalability and CustomizationStarting Price: $100/month -
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Ofni Clinical
Ofni Systems
Ofni Clinical is a clinical data management tool that rapidly creates and implements secure, regulatory compliant clinical trial databases. Ofni Clinical includes comprehensive search and report features, has strong data validation and edit check options, contains flexible customization tools, and can be implemented quickly and economically. The databases can be used to capture data from existing paper Case Report Forms or as paperless electronic data capture systems. Many Ofni Clinical projects require less than a month to go from project initiation to validated implementation. Contact us today and find out how to use Ofni Clinical for your clinical trials. Matches your existing Case Report Forms (CRFs), reducing training and implementation costs while adding electronic data capture and review capabilities. Includes extensive edit check and data validation features to identify questionable data entry and support data analysis. -
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Suvoda
Suvoda
Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas such as oncology, central nervous system disorders, and rare diseases. Founded in 2013, Suvoda offers an integrated platform that includes Interactive Response Technology (IRT), electronic Consent (eConsent), electronic Clinical Outcome Assessments (eCOA), and ePatient solutions, all designed to manage critical patient interactions efficiently. Their patented software architecture ensures a seamless user experience, facilitating precise randomization, drug supply management, and real-time data collection. Committed to enhancing patient comprehension and reducing site burdens, Suvoda's solutions are built to adapt to the evolving complexities of clinical trials. Headquartered near Philadelphia, with offices in Europe and Asia, Suvoda has supported over 1,500 trials across more than 85 countries. -
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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. -
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Clindex
Fortress Medical Systems
A Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC) all in one powerful, integrated solution. All your study information can be at your fingertips with our innovative, flexible and compliant Clinical Trial Software System. Our servers or yours. ClindexÂŽ can be installed on your servers or it is available on the Fortress Medical Cloud (SaaS â Software as a Service). Cloud access is available world-wide and your data is securely stored at a SOC 3 certified data center. You can build, we can build. ClindexÂŽ provides all the tools you need to develop your own study database. Our quick start manuals and help documentation walk you through the process, step by step. Or our Clindex services team can develop a study for you. -
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Dacima Clinical Suite
Dacima Software Inc.
Dacima Clinical Suite is the most advanced web-based solution that combines electronic data capture (EDC), clinical data management software (CDMS), and clinical trial management software in a single platform. Built for clinical trials, epidemiological research, web randomization (IWRS), ePRO, web surveys, and patient registries, Dacima Clinical Suite helps efficiently streamline the clinical data collection process. Dacima Clinical Suite consists of three core modules: Manager (Administrator) Module, Designer Module, and Data Entry Module. -
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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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Trialpack Designer II
Fleximation
Trialpack Designer is an easy-to-use and powerful tool to design blister packs and cards for clinical trials. It is particularly well suited to design packages for complex blinded trials such as dosage titrations, double-dummy and cross-over trials where a pack contains a range of different products. It provides configuration data for the Trialpack PC Controller, the Trialpack Controlled Dosing Systems and the Trialpack Robotic Packaging Systems. Direct and easy on screen design of blister shapes, print images and filling patterns. Highly granular user access rights. Workflow features with electronic signatures. Detailed 21 CFR Part 11 compliant audit trail. Reports with detailed packaging instructions and material requirements. -
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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, weâre 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. -
40
Calyx
Calyx
At Calyx, we know that the success of your clinical development program comes down to data. Which makes the effectiveness of your electronic data collection (EDC) system key. Used in over 2,600 worldwide clinical trials, Calyx EDC streamlines clinical trial data collection and reportingâin one easy-to-use platform. Donât trust your important data to just anyone. Contact us to learn how Calyx can propel your programâs success. Calyx EDC gives you the flexibility to easily plan, design, and conduct studies, regardless of their complexity. With features that help reduce costs, improve site visibility, and drive efficiency, Calyx EDC keeps your trial on track. -
41
AcceleTrial
LINEA System
AcceleTrial⢠takes the guesswork out of clinical trial site identification and activation. Our Study Start-up Management System (SSMS) is based on the foundation of objective data and not self-identification. AcceleTrial⢠gives you a database of thousands of sites globally that are ranked and indexed on the basis of: Objective Site-specific Therapeutic Expertise, Objective Site-specific Clinical Trial Experience and Objective Patient Data. Objectively pair the right sites globally with objective data on expertise, experience and patients to your clinical trials. Expediently launch the right sites to begin enrolling patients using AcceleTrial⢠automated âpush and pullâ structure presented in multiple languages. Accurately collect required documents using pre-filled templates and track activities in real-time. Immediately start using system â cloud-based solution requiring minimal IT set-up or training. Simply integrate AcceleTrial⢠with CTMS or other clinical trial systems. -
42
Clinibase
Cardiobase
Our platform offers the comprehensive support that your clinical trial needs using cutting-edge cloud-hosted technology. Clinibase will help your organization realize significant gains in efficiency and productivity. We do not adopt a plug-and-play approach with our Clinical Trial Management System. Why? Because we believe that every organization has unique systems and processes. Therefore, Clinibase can be fully customized to fulfill your organizationâs clinical trial needs and requirements. Furthermore, we use surveys to troubleshoot, recognize areas for improvement, and automate all components of your daily clinical trial processes. Quickly locate eligible participants with our social integration tools to recruit them faster. Keep your participants engaged with smooth communication tracks that enable high retention and foster positive participant experiences. Enhance the validity of your trials knowing that data is recorded accurately and stored safely. -
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OpenText for Life Sciences
OpenText
OpenText⢠Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts. -
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Korio
Korio
Korio is the Randomization & Trial Supply Management (RTSM) platform designed for flexibility, quality, and speed. Not just built to tackle clinical trial challenges as they come, but built to prevent them in the first place. No matter what trials you may face, Korio is prepared to handle them. Legacy RTSM systems are not built to support the trend toward increasingly complex study designs. Brittle RTSM platforms do not easily accommodate on-the-fly RTSM design updates to match clinical trial changes. Inspired by decades of hands-on experience. The result is an RTSM platform where flexibility meets reliability, and modernity meets experience. Streamline your user experience with Korio's intuitive, role-based interface. From site users and supply managers to clinical operations and data managers, empower everyone to work faster and take action with confidence. Experience consistent management of your trial. -
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TrialPoint
Databean
TrialPoint⢠electronic data capture (EDC) is easy to configure, easy to use, and the coordinators love it. Our data managers are experts in converting clinical protocols into geek-speak (metadata dictionaries for those in the know) and will configure TrialPoint⢠to work for you, not against you. The system can accept any randomization string, media upload, or coding dictionary. It can even blind users to treatment assignments. To promote time-sensitive data collection. the system will prospectively calculate visit windows and send out alerts and reminders keeping the team focused and on task. Nowadays, patient-reported health outcomes and quality of life questionnaires are included in most trial designs and are responsible for many protocol compliance issues. Take a look at TrialPointâs electronic patient-reported outcomes (ePRO) module which can be configured to fit any quality of life questionnaire or patient diary. -
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Clinical Concepts
IVR Clinical Concepts
IVR Clinical Concepts specializes in providing virtual clinical trial technology and patient engagement solutions. Their offerings include electronic patient-reported outcomes and patient diaries, which aim to deliver better data with fewer errors, resulting in shorter timelines and lower costs. They also provide patient recruitment and outreach services, focusing on outreach, pre-screening, and real-time data collection. Their subject screening, registration, and randomization solutions are described as modular, custom, flexible, and configurable. Additionally, IVRCC offers clinical trial material management solutions designed to reduce workload while providing more control, as well as eClinical integration services to seamlessly thread data together. Their chart review services provide real-world data and clinical insights. IVRCC emphasizes custom, modular, and configurable solutions to improve the patient experience and optimize clinical trial success. -
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Folio3 Clinical Trial Management
Folio3 Digital Health
Folio3 Digital Health's Clinical Trial Management Software (CTMS) is a comprehensive, web-based platform designed to streamline the entire clinical trial lifecycle for pharmaceutical companies, CROs, and research organizations. It centralizes trial operations, from planning and site management to data collection and reporting, ensuring compliance with global regulations like FDA 21 CFR Part 11, GxP, and HIPAA. The software emphasizes user-friendly interfaces, real-time dashboards, and scalable modules to handle trials of any size efficiently. Core Modules The platform features dedicated modules for study setup, where users define protocols, timelines, and budgets with customizable templates. Site management tools track investigator qualifications, contracts, and payments, while patient recruitment capabilities include screening, enrollment tracking, and visit scheduling with automated reminders.Starting Price: $300 -
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Clinials
Clinials
Clinials Trial Search simplifies complex trial info using AI, boosting participant engagement and enrollment rates. Benefits: Enhanced Engagement: Empowering potential participants with plain language descriptions. Wider Reach: Access a diverse pool of eager participants seeking clinical trial opportunities. Listing on Clinials Trial Search is free. We also offer referral fees from $300- $5,000 based on trial complexity.Starting Price: $300 -
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WCG ClinSphere
WCG
WCG ClinSphere is a trailblazing approach for running clinical trials end to end. Leveraging the power of artificial intelligence, the platform connects sites, sponsors, CROs, and participants in one unified cloud platform. One place to manage your trial efficiently from start to finish. The WCG ClinSphere platform architecture is underpinned by four tenets of efficiency. Our unsurpassed clinical dataset feeds into a federated AI learning model, enabling smart automation across the clinical trial lifecycle. Access up-to-the-minute reports and insights to stay informed and make timely decisions. Simplify tasks and enhance accuracy with easy-to-understand workflows that guide you every step of the way. Streamlined logistics, operations, and processes throughout the clinical research journey. The power of vast data stores and deep analytics to make the connections necessary for faster clinical research. -
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Trials.ai
Trials.AI
Our Smart Protocol system aims to automate and add intelligence to clinical trial design with AI. Our Smart Protocol solution is revolutionizing the manual way research teams design clinical trials. In the digital age, humans cannot physically read and digest every bit of information relevant to a given decision. In addition, almost every company has valuable data that is not being used - more often than not, documents are living in repositories with no line of sight. As a result, companies life science companies are making important and costly decisions with incomplete information. We aim to take companies like yours from a document-driven environment into a data-driven one. We are reimagining how clinical trials are researched and planned by removing the barriers between data and end-users. We do this by mining massive amounts of trial-related documents from both customers and the public domainâ so you donât have to.Starting Price: $20 per month
