Alternatives to eTMF Connect

Compare eTMF Connect alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to eTMF Connect in 2026. Compare features, ratings, user reviews, pricing, and more from eTMF Connect competitors and alternatives in order to make an informed decision for your business.

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    OpenClinica

    OpenClinica

    OpenClinica

    OpenClinica is a leading provider of clinical trial technology, offering a comprehensive suite of solutions to enhance the efficiency and effectiveness of clinical research. The platform provides electronic data capture (EDC), patient recruitment, eConsent, and clinical data management solutions, all designed to streamline workflows and improve data quality. OpenClinica also integrates EHR-to-EDC connectivity, allowing for seamless data acquisition and reducing errors. Trusted by life sciences companies, academic institutions, and government agencies, OpenClinica supports over 15,000 studies and has helped manage data for more than three million patients worldwide.
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    LifeSphere eTMF
    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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    Cloudbyz eTMF
    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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    Clinion eTMF
    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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    Clienvo eTMF
    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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    LifeSphere CTMS
    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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    ImproWise

    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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    SimpleTrials

    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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    Zapclinica

    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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    BSI CTMS

    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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    cubeCTMS

    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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    GRAVITY

    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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    ClinVigilant

    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! Clinvigilant💊, your one-stop 🌐solutions provider for ☁️clinical trials. Enquiries > bd (at) clinvigilant.com
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    Cloudbyz EDC
    Cloudbyz EDC is a cloud-native solution with an intuitive interface that is designed to store and manage clinical data effectively throughout a clinical trial’s life cycle. Our innovative solution enables clinical research teams to efficiently collect, analyze, and manage clinical data of different complexity and size. Build your study without code, with an interface that helps users build forms and easily navigate to the appropriate screens for data collection and analysis. ̌The all-new Cloudbyz EDC application comes packed with user-friendly features. All other Cloudbyz applications such as CTMS, eTMF, CTBM, RTSM and Safety/ PV are native to the same platform as our EDC, allowing customers to have one single source of truth for a clinical trial. Furthermore, you can set up each study independently.
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    LifeSphere EDC

    LifeSphere EDC

    ArisGlobal

    Cost-effective data capture. LifeSphere EDC delivers sponsors and CROs a cost-effective way to capture, manage and report clinical research data regardless of trial phase and complexity. Combine disparate systems into a single unified database eliminating the need for costly integrations and reconciliation. Captures clinical data direct from site, eliminating the need for paper CRF and data entry. Reduce study development times and create seamless implementation of changes to live studies. Unified with the LifeSphere Clinical cloud platform – including LifeSphere eTMF and LifeSphere EDC – to seamlessly connect operations with data management. Single sign-on functionality provides simple access to a suite of applications, while open architecture ensures rapid integration with third party applications via API.
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    oomnia

    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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    myClin

    myClin

    myClin

    Document control and collaboration. myClin acts as a collaborative, living eTMF solution. Upload and share study documents in seconds on your central and secure myClin channels. Easy access allows for accelerated delivery of critical study updates and training. Oversight as you go. Our “File it” feature provides visibility on who has read and understood your study materials. Record evidence of good study execution while reviewing training actions including views, filing, or downloading at the team or individual level. Inspection Readiness. Stay inspection ready at all times. Our compliance score indicates how compliant each site or study team member is in engaging with their appropriate study information. You are proactively guided to less compliant areas of your study, continuously improving risk management. In just a few hours, we will create a myClin channel for you to try myClin with your team. As simple as that.
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    Agatha

    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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    RegDocs365

    RegDocs365

    Court Square Group

    Out-of-the-box, scalable, real-time collaborative solution for CRO’s, Life Science Consultants, Regulatory Groups and Industry Stakeholders. Built in an Audit Ready Compliant Cloud (ARCC) environment. Meets all 21 CFR Part 11 requirements. GxP audit ready. Pre-configured Departmental. Internal/External stakeholder communications. Secure data integration across remote teams. Collaborative review and approval workflow. Turn access on/off as needed (EX: auditors, reducing audit prep time to hours vs days). Preconfigured to EDM & eTMF Reference Models. Improve workflows through intelligent content management tools. Unify and improve the document management lifecycle with real-time collaboration, automatic indexing, and co-authoring capabilities. Pre-configured validated system that easily manages documents and data electronically that complies with eCTD mandates.
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    Ennov Process
    The Ennov platform includes its own workflow engine that provides advanced capabilities. Workflows are used in Ennov Training, Ennov eTMF and Ennov RIM. They allow control of the sequencing of tasks and data modification while providing visibility across the organization. Workflows are entirely configurable by functional administrators (through a graphical interface). Coherence checks are performed whenever you save modifications in order to make sure they do not cause inconsistencies. Thus, Ennov guarantees workflows are coherent and reliable. Each Ennov workflow is associated with a configurable form. Data entry is facilitated using dynamic sections that are displayed – or not – depending on previously entered field values (for example: the type of Incident). The connected user enters free text, selects values in picklists and adds additional files when needed. An electronic signature can also be required to complete a workflow step.
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    Zelta

    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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    Jeeva eClinical Cloud

    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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    Oracle Siebel Clinical Trial Management
    Improve productivity by streamlining, automating, and reporting on clinical trial operations data across all study management processes. Siebel CTMS is a comprehensive, scalable, integrated trial management suite that improves operational efficiency by standardizing clinical operations workflows and providing real-time visibility to data. Siebel CTMS provides trial management capabilities that help you manage and monitor trial operations from start to finish. Siebel CTMS improves data quality with workflows that can be configured to meet individual customer processes for all research studies. Siebel CTMS can be integrated with advanced analytics capabilities that provide you with timely, fact-based insight into clinical programs to drive informed business decisions. Get real-time access to complete and trustworthy clinical trial data so you can make better decisions quickly, effectively, and easily.
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    Medilake

    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 Customization
    Starting Price: $100/month
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    assisTek

    assisTek

    assisTek

    AssisTek is a leader in innovative clinical technology solutions for clinical research, offering custom clinical software solutions to streamline and enhance patient data collection. With over 25 years of excellence, they have supported more than 800 clinical research trials across 46 therapeutic areas, including over 500 multinational Phase I–IV clinical trials. Their eCOA solutions are highly scalable, customizable, and efficient, powered by a proven, cloud-based technology platform. AssisTek's product suite includes TEK eCOA Tablet, designed to support any questionnaire used in a clinical trial, TEK eDiary for capturing patient-reported outcomes at home, TEK Configurator for building clinical trial projects from start to finish, and TEK Study Portal for eClinical tracking, training, and reports in one place. Their systems and services have made them the top choice for collection and analytics among patients and clinicians.
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    Cloudbyz CTMS
    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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    Omda MedSciNet
    Omda MedSciNet solutions improve the quality, utility, and management of medical data from collection to analysis. This secure standardized software makes it easy for clinical researchers and other professionals in medicine and academia to gather and analyze well-managed medical data. The Omda team specializes in building and managing tailor-made database applications and designing clinical studies for medical research and quality registers. The Omda MedSciNet study platform provides a reliable, feature-rich, and highly customizable online environment for hosting and managing sophisticated study and clinical trial systems. Omda MedSciNet has a 20-year track record of successfully hosting studies and clinical trials of all scopes and sizes. The standard implementation includes a comprehensive set of components necessary for establishing fully functional studies or clinical trials.
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    Mosio

    Mosio

    Mosio, Inc.

    Mosio enables research teams to improve subject adherence, communications, and data collection on mobile’s most popular channel: text messaging. Our software makes research teams more efficient in how they communicate with study participants through messaging automation and interactive elements delivered to participant mobile phones. WHO WE HELP: + Clinical Trial Sponsors (Pharma and Biotech) + Cancer Centers and Clinical Research Organizations + NIH-Funded Studies + Public Health Agencies + Clinical Trial Managers, Clinical Operations Managers/Directors, Clinical Project Managers, Principal Investigators, Clinical Research (Study) Coordinators, and any research staff who communicate regularly with study participants. BENEFITS: + Interactive dosing reminders and medication adherence alerts. + Automate data collection. + Increase engagement and adherence. + Fix your no-show problem with SMS appointment reminders. + Improve retention with automated check-ins.
    Starting Price: $99/month
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    Oracle Clinical One
    Clinical One RTSM can support a randomization strategy for the simplest to the most complex studies without the need for programming or coding, which eliminates the need for prolonged user acceptance testing. Take control of your study through self-service configurations and build a study in days instead of weeks. Assess the status of the drug inventory and make modifications in real-time without reverting to the vendor and incurring cost and change requests. Eliminate change request costs and avoid delays by quickly implementing changes and promoting your studies in seconds. The only platform that truly unifies people, processes, and data to simplify and accelerate the clinical trials of the future. Virtual components in clinical trials allow greater patient participation and significantly improve clinical trial data quality. Transformative digital strategies are needed for faster study startup to harmonize data from any source and to streamline workflow.
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    Clinical Research IO

    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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    TrialStat

    TrialStat

    TrialStat Solutions

    Compared to other EDC solutions on the market from MediData, DataTrack, Omnicomm and others, TrialStat is the most all-encompassing suite of study management tools that can be seamlessly connected to external data sources such as EMR, wearables, and other clinical and non-clinical data and information sources. TrialStat offers a fully unified platform suitable for all phases and types of trials. Our single-sign-on, multi-tenant EDC suite includes modules for Randomization, Adjudication, Coding, Safety, Patient Diaries/ePRO, Vendor Neutral Imaging Archive, a robust Reporting and Analytics Portal and custom Machine Learning programs. With a focus on data analytics, TrialStat offers real-time reporting, data extracts on demand, and analytics across a single study, a program, or your entire research portfolio – providing all stakeholders relevant, customized, timely insight into all aspects of study data and highlighting areas of risk or potential delays.
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    BizNet

    BizNet

    Sarjen Systems

    Sarjen delivers an AI-enabled Clinical Trial Management System and Bioanalytical LIMS that drives digital transformation across early-phase and late-phase clinical trials. This integrated eClinical platform supports end-to-end trial management, site management, subject tracking, regulatory compliance, and real-time laboratory sample management within a unified ecosystem. Built for pharma, biotech, and CRO organisations, the software enhances operational efficiency through workflow automation, centralised data management, and advanced analytics. Its AI features include predictive enrollment forecasting, risk-based monitoring insights, anomaly detection in lab data, automated query resolution, and intelligent dashboards that improve decision-making. By leveraging machine learning and smart automation, the platform accelerates study timelines, improves data quality, ensures compliance readiness, and transforms clinical research operations!
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    WCG ClinSphere
    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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    CTMS Master

    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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    Teckro

    Teckro

    Teckro

    Teckro clinical trial software connects all study stakeholders to critical information. Every time. Everywhere. We find answers every day from our smartphones. Why shouldn’t the same be true for clinical trials? Critical, up-to-date study information always at hand when and where research staff and CRAs need it. Study answers are just a tap away on any mobile device, giving research staff a direct line to crucial details. And when updates or amendments are needed, site staff and monitors can be alerted in real-time. Cloud-based clinical trial software, Teckro is up and running quickly with nothing to install. It’s simple, easy and intuitive. Teckro is securely hosted and compliant with major industry regulations, including FDA 21 CFR Part 11. Only the right, approved version of study documents, means no more worrying about version management.
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    Longboat

    Longboat

    Advarra

    Longboat is a cloud-based clinical trial support solution provides users with an integrated Guided Compliance toolset to guide them at all times. Longboat provides the clinical trial site staff with the right resources to let them focus on patients. Longboat allows patients to view essential study information and check visit reminders. Longboat allows users to seamlessly manage the controlled rollout of the amended clinical trial protocol. Centralize the secure exchange of regulated documents between sponsors, CROs, and sites, significantly streamlining study startup and eliminating historically cumbersome processes across research stakeholders. All key stakeholders—clinical operations, monitors, site staff, and participants—access one integrated support platform with content tailored to meet their specific needs. Provide your site staff the tools and resources they need to stay engaged and compliant while focusing on the participant.
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    REDCap Cloud

    REDCap Cloud

    REDCap Cloud

    REDCap Cloud is a unified data-science platform that enables organizations to collect, integrate, standardize, analyze, and share real-world and regulatory-grade clinical and research data using a single standards-based system. It supports the full lifecycle of randomized clinical trials and real-world evidence studies by offering modules for complex trial design and deployment, a clinical data hub that converges eCRF and non-eCRF sources, real-time operational and data insights via AI/ML, eSource and EHR connectivity, patient engagement (ePRO/eCOA, wearable devices) for hybrid or decentralized trials, analytics including synthetic control arms and digital twins, and global compliance with security standards, all built to reduce data-silos, eliminate vendor fragmentation, deliver bidirectional data flows and give sponsors, CROs and health-systems end-to-end visibility and control across site performance, study data quality and regulatory readiness.
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    Calyx

    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 reporting—in one easy-to-use platform. Don’t trust your important data to just anyone. Contact us to learn how Calyx can propel your program’s 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.
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    Medidata

    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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    SMART-TRIAL

    SMART-TRIAL

    SMART-TRIAL

    Get closer to your clinical data with SMART-TRIAL, the leading Electronic Data Capture (EDC) platform for MedTech. A complete data collection toolbox for Post-Market Clinical Follow-Up (PMCF) and Clinical Investigations. Built to empower clinical teams to be their best and in full control of their clinical data without compromising on features, design, or compliance.
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    OpenText for Life Sciences
    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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    Veeva SiteVault

    Veeva SiteVault

    Veeva Systems

    Streamline regulatory operations across your organization to improve compliance and advance research. Veeva SiteVault reduces the complexity of conducting clinical trials by connecting your regulatory operations to improve efficiency and compliance. Manage regulatory and source documents in a single system that supports 21 CFR Part 11 and HIPAA requirements. With a real-time visibility across trials, SiteVault Enterprise improves operational efficiency, speeds study activation, and enables faster, higher-quality trial execution. Replace manual processes and design your own workflows to support quality and speed study activation. Eliminate the need to grant EMR access or redact documents by providing monitors with secure, direct access to your regulatory and source documents. Create your own workflows, reports, and dashboards for greater visibility into start-up timelines and regulatory processes.
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    Intrinsic CTMS

    Intrinsic CTMS

    Intrinsic Clinical Systems

    Intrinsic’s clinical trial management system (Intrinsic’s CTMS®) has been designed with the end user in mind - minimizing data entry and focusing on proactive study management. Cloud-based, with a streamlined interface, the ability to manage studies at any level, and a task-based design, Intrinsic ushers in a new era of trial management tools. Intrinsic® is the world’s first CTMS built with native integration with all Microsoft applications, including Outlook, Excel, SharePoint, and Power BI. With Dynamic Worksheets, users can quickly import bulk data and study updates from CROs (using the CRO clinical trial management software), without the need to integrate systems, as well as create ‘live’ exports for ad-hoc analysis and reporting. Intrinsic CTMS® also leverages Power BI, a cloud-based reporting tool, which enables users to report on data from other clinical systems, such as EDC and IRT, with having to build costly data warehouses.
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    Rave CTMS

    Rave CTMS

    Dassault Systèmes

    Study teams are increasingly being challenged to do more with fewer resources. Delays caused by disconnected systems, manual data re-entry, redundant workflows, and information silos can seriously affect a trial’s progress. You need a clinical trial management system that unifies and streamlines workflows while still maintaining full visibility, and Medidata has the solution. Rave CTMS is the only data-driven solution for faster, smarter, end-to-end trial management. As an integral part of the Medidata Rave Clinical CloudTM, Medidata provides all of the elements you expect from an industry-leading CTMS and more. Rave CTMS provides your study teams with the ability to plan and manage all of your clinical trials in a consistent and harmonized manner that standardizes activity planning and management at the study, country, and site level. Activities include study/site team creation and activation, patient enrollment and milestone tracking, site monitoring, and issue management.
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    Leapcure

    Leapcure

    Leapcure

    Leapcure is a leading patient recruitment and engagement platform that connects clinical trial sponsors with eligible patients. Utilizing advanced technology and strategies, we enhance trial participation and improve patient outcomes. Our platform streamlines the recruitment process, ensuring that trials are populated with suitable candidates quickly and efficiently. Leapcure is dedicated to advancing medical research by making clinical trials more accessible and effective. We work closely with sponsors and patients to facilitate smooth and successful trial experiences, ultimately contributing to the development of new treatments and therapies.
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    AcceleTrial

    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 “push and pull” structure presented in multiple languages. Accurately collect required documents using pre-filled templates and track activities in real-time. Immediately start using system – cloud-based solution requiring minimal IT set-up or training. Simply integrate AcceleTrial™ with CTMS or other clinical trial systems.
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    Clinical Concepts

    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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    TrialKit

    TrialKit

    Crucial Data Solutions

    TrialKit is a unified eClinical platform that brings mobility, automation, and efficiency to modern research teams. Accessible from any browser or native app (iOS, Android, and Mac), TrialKit supports rapid study setup, real-time data collection, and centralized oversight—ideal for CROs and sponsors seeking agility without compromising compliance. Its drag-and-drop design tool makes it easy to build studies quickly, while advanced features like AI-powered reporting and mobile ePRO/eCOA enhance visibility and decision-making. Trusted by over 40,000 across the globe, TrialKit enables teams to work smarter from first patient in to database lock. Recognized with the 2024 SCDM Innovation Award, it’s the all-inclusive solution for today’s studies.
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    Unlearn

    Unlearn

    Unlearn

    Advancing AI to eliminate trial and error in medicine. Our digital twins enable confident and quick clinical trials. We work in neuroscience, immunology, metabolic disease, and more. TwinRCTs reach full enrollment sooner because they require fewer patients to achieve the same power as traditional trial designs. Shorten time to enrollment in late-stage studies. TwinRCTs improve the ability to observe treatment effects in early-stage studies by increasing power without adding more patients. Make confident decisions from early-stage studies and attract study participants. TwinRCTs give participants a greater chance of receiving the experimental treatment because they use smaller control groups. Position clinical trials with digital twins for regulatory success. Unlearn is engineering the future of medicine with artificial intelligence. We invent and deploy new types of generative models trained on extensive patient-level data from previous studies.
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    Simple Trial

    Simple Trial

    Trial by Fire

    SimpleCTMS was designed and developed to offer the benefits of a CTMS (Clinical Trial Management System) without the extensive upfront financial and resource commitments associated with traditional enterprise systems or the inherent inefficiencies of worksheet trackers. SimpleCTMS provides early-stage drug developers a scalable and cost-effective solution to improve the management, performance and study startup costs associated with clinical trials. A dedicated client manager provides pro-active support and guidance. All users receive technical support from our team of clinical software experts. Customized training and professional services are available at additional cost. Backed by a quality system using validated software processes.
    Starting Price: $399 per month