Alternatives to Clienvo eTMF
Compare Clienvo eTMF alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Clienvo eTMF in 2024. Compare features, ratings, user reviews, pricing, and more from Clienvo eTMF competitors and alternatives in order to make an informed decision for your business.
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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 eTMF
Clinion
Clinion's electronic trial master file (eTMF) system has unique features that simplify storage, access, and management. The simple user interface makes it the go-to tool for clinical trial document management. -
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Clinevo CTMS
Clinevo Technologies
Clinevo Clinical Trial Management System (CTMS) is a cloud based, highly configurable, end-to-end platform which helps manage all aspects of clinical trials. It meets all the regulatory guidelines including security, access control, change controls, audit trails, and system validation. -
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Cloudbyz Safety & Pharmacovigilance Solution is a cloud-based software solution designed to streamline the drug safety and pharmacovigilance operations for pharmaceutical and life science companies. The solution helps to automate the process of collecting, processing, analyzing and reporting adverse event data in compliance with global regulatory requirements. Cloudbyz Safety & Pharmacovigilance Solution enables companies to reduce risk, improve compliance, and enhance patient safety while accelerating drug development. Cloudbyz provides end-to-end management of the pharmacovigilance lifecycle, including adverse event processing, case management, regulatory reporting, signal detection, and risk management. With Cloudbyz, you can optimize your pharmacovigilance processes, accelerate case processing, and increase the accuracy of your safety data, while minimizing risk and ensuring compliance.
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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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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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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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ClinSoft
Innovate Research
Innovate’s End-To-End Clinical Data Management Services. Our clinical data management processes, expertise and technology are developed to make each step of your clinical trial data management process more accurate and efficient for Phase I-IV in wide range of therapeutic areas. Our CDM Team Is Well-Versed With Current Good Clinical Data Management Practices (cGCDMP) International conference on harmonization Good Clinical Practices (ICH-GCP) 21 CFR Part 11 Compliance Health Insurance Portability and Accountability Act (HIPPA) Requirements Applicable Regulatory Guidelines SAS datasets SAS XPORT transport files EDC Helpdesk Support 24/7 On-Site and Off-Site Clinical Data Management Services Electronic Data integration and transfer Quality Control Activities Medical Dictionary for Regulatory Activities (MedDRA) Serious Adverse Event (SAE) Reconciliation Clinical Database Transfers Clinical Database Lock paper Case Report Form (pCRF) and electronic Case Report Form. -
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LifeSphere eTMF
ArisGlobal
LifeSphere eTMF is your clinical trial’s single source of truth. Discover a versatile solution that streamlines inspections, ensures compliance, and saves your organization time and effort. Built as the first system to support the TMF reference model, LifeSphere eTMF aligns Clinical documentation with regulations and study protocols in one solution. Create and manage a single source of truth for your clinical trial. Ensure trial master file quality, timeliness, and completeness with live collaboration and real-time document sharing. Streamline TMF inspections quickly and efficiently to handle any audit. Maintain compliance with embedded workflows and dashboards that allow easy trial reconstruction. -
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Saama
Saama
Actionable insights, driven by the industry's #1 AI-powered clinical analytics platform, enable your teams to manage risk and improve performance across studies, systems, sites, and vendors. State-of-the-art clintech from Saama is designed to streamline your workflows, automate time-consuming processes, and improve collaboration across clinical operations, medical review, data management, biostatistics, and pharmacovigilance. Sponsors and CROs rely on Saama for data aggregation and artificial intelligence solutions that lead to better decision-making, eliminate delays, and significantly shrink drug development costs and timelines. Saama can put you on the fast track to clinical trial process innovation. When all your clinical data is in one place and updated in real time, life’s much easier for your ClinOps and medical review teams. Data Managers have been underappreciated for too long. Eliminate manual work so they can pay attention to the data points that matter. -
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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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Fusion eClinical Suite
Axiom Real-Time Metrics
Fusion is Axiom’s proprietary easy-to-use and cost-effective eClinical solution that is focused on small to medium sized device, pharma, and biotech companies. With Axiom’s Fusion eClinical Suite, you can add-on any Modules to meet your study requirements. Running a small study? Just choose the base configuration with EDC, DM and AE/SAE Tracking. Running something more complex? Include powerful Modules such as Inventory Tracking, RTSM, Safety Management to make the management of your study so much easier. Save time by capturing your study data electronically – even when offline! Data syncs to your Fusion databases once an internet connection is established. Access real-time records for Subject screening activities. Safety Database for the management of pharmacovigilance events directly within Fusion. -
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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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Clinion CTMS
Clinion
Most Easy-to-Use Clinical Trial Management System (CTMS) 𝐂𝐥𝐢𝐧𝐢𝐨𝐧 𝐂𝐓𝐌𝐒 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 you’ll 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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Complion
Complion
Complion’s platform is the accepted standard built specifically for clinical researchers. Our solution ensures the highest level of compliance with the greatest efficiency and the least amount of work. Allowing you to focus on what really matters — advancing and improving patient outcomes. Whether you are a Research Site, Sponsor or CRO, our eReg solution can help you address any type of clinical trial challenge, now and in the future. Reduce costs, avoid redundancy, and increase staff productivity. Easily archive, get signatures and view files from anywhere or from any device. A built-in audit trail ensures accuracy and eliminates study conduct and patient safety risks. Our clients include leading cancer centers, medical centers, hospitals, and health systems, as well as multi-specialty practices and dedicated research sites. -
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Datatrak
Datatrak International, Inc.
Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak’s unified eClinical solutions and related services help improve cost and time efficiencies for the clinical trials industry. Datatrak built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via Datatrak’s Clinical and Consulting Services group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. Our commitment is to empower workgroup teams with role-based access to version-controlled file management, calendar events, tasks and contacts, all built within our eClinical applications including EDC, CTMS, reporting, data analytics and business intelligence. -
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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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Clario eCOA
Clario
Unlock better evidence with high-quality ePRO and eClinRO. Electronic Clinical Outcome Assessments, or eCOA, measure how patients feel or function during clinical trials. By capturing clinical data electronically, you can be confident that your patient’s data is high-quality and regulatory-compliant. Put simply, eCOA avoids the quality and time issues associated with paper diaries, such as illegible answers, transcription errors and inconsistent or conflicting data. Also, the FDA recommends ePRO. Patient-reported outcomes, patients report on their health via questionnaires or assessments. Examples include quality of life or activity outcomes. The clinician reported outcomes. Health outcomes are reported by a clinician. An example may include a physical examination such as PASI. Performance outcomes are measures from specific tasks the patient is asked to perform. An example might be performing a timed task. -
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BSI CTMS
BSI Business Systems Integration AG
BSI CTMS convinces with his trend-setting interface and the intelligent visualization of data. Behind the optics, our clinical trial management software is packed with functions that support pharma, biotech and diagnostics sponsors, as well as CRO and academics (SMO) in their daily world for managing clinical trials in a targeted way. BSI CTMS is being constantly further developed, based on market requirements and in close collaboration with our existing customers. BSI CTMS stands out with its comprehensive functionality, providing CTMS, eTMF, Study Startup and Trial Supply Management RTSM in one integrated unified platform. It’s time to say goodbye to Excel and other stand-alone solutions. You decide if BSI CTMS shall be hosted in the cloud by BSI or on-premise on your IT infrastructure, it is up to you! You can even start in the BSI cloud in order to speed up the project implementation and then later change to on-premise hosting. No vendor locking using BSI CTMS. -
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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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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. VACAVA’s Regulatory Document Management System was built in collaboration with a major clinical trial research base to simplify operations and radically increase efficiency. VACAVA’s Regulatory Document Management System is surprisingly affordable and can be customized to meet your unique needs. VACAVA’s 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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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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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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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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Catchtrial
Meditrial Europe
Catchtrial is the online electronic solution to manage CRFs and images with efficacy and speed. Simple, secure, affordable, Catchtrial has been chosen by leading manufacturers and small companies alike to manage their international trials. By replacing the paper-based process, Catchtrial ensures cost savings. No monitor visits to sites will be needed to collect paper CRF. You can also capture and upload images, so there will be no need to ship CD roms. Sponsors have full control of the study progress, simply by accessing the study from their offices. Compared to other eCRF offerings, Catchtrial offers special functionalities and flexible personalizations for unprecedented ease of trial management. -
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TCS ADD
Tata Consultancy Services
TCS ADD platform accelerates speed-to-market for pharmaceutical industry across the entire clinical R&D value chain and helps make clinical trials more agile and safe. TCS ADD enables digital ecosystems, simplifies data complexity and provides faster access to new and effective drugs for the patients. The platform is powered by cognitive artificial intelligence engine called TCS Decision FabricTM, smart analytics and IoT that provides superior business value to pharmaceutical industry. A next-generation and end-to-end metadata-driven solution to manage industry & sponsor clinical standards. A data science-driven platform that leverages AI & ML technologies to enable quicker decisions, faster study start-up and targeted interventions. A solution that digitizes the entire clinical trial supply management process while putting the patient in the center, increasing patient’s safety and overall efficacy. -
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Ennov CTMS
Ennov
Ennov CTMS facilitates the end-to-end management of clinical trials. The software allows sponsors to be more efficient, to make better decisions, to ensure compliance, to select investigators well, to monitor patient recruitment and to manage finances. Ennov CTMS includes comprehensive directories to manage site personnel (investigators, sub-investigators, study coordinators, pharmacists) and organizations (hospitals, competent authorities, CROs, suppliers). Ennov CTMS provides functions for tracking patients, patient visits, EDC data, activities, queries, deviations, adverse events, drug supply, monitoring visits and finances. A full complement of reports and dashboards provide total visibility into the status of each study, country, site and investigator to provide the information necessary to make the best decisions possible. - Comprehensive CTMS software - Integrated with Ennov Clinical Data Management - Clear visibility into investigational sites - Integrated workflow -
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BREEZE CTMS
BREEZE CTMS
Electronic source documents – eSource – eliminates paper, standardizes and simplies workflow, and reduces errors and omissions. BREEZE eSource goes way beyond visit templates and scheduling. By synchronizing clinical contexts, regulatory and protocol requirements, with study procedures, BREEZE eSource ensures that users not only capture all protocol required data. BREEZE business rules make certain that the data collected are correct, complete, accurate, and compliant. Our dedicated team of clinical trial experts delivers custom, study-specific eSource documents for review and approval before study start-up and supports you throughout the trial and modifies them as needed. Modules seamlessly integrate and work together. Cross-Module Action Multiplier goes a step further by anticipating and completing automatically the additional tasks required by entries you make. For example, completing visits or procedures automatically posts to invoicing, recalculates scheduling, and more. -
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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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Transition Technologies eCRF
Transition Technologies Science Sp. z o.o.
Flexible eCRF platform for non-commercial clinical trials, configurable to any clinical trial study protocol. Our eCRF solution was created on the basis of many years of experience of researchers and medical teams with whom we carried out research projects. The system is, above all, easy to use, user-friendly and extremely flexible. The prepared solution meets all the required quality standards, and thanks to the full control over the code, we can further develop and adapt it to the changing requirements of regulators and the clinical trials market.Starting Price: $45k licence -
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Phoenix CTMS
Medical University of Graz
Phoenix CTMS is a modern web application combining the capabilities of database software used in clinical research in one modular system. After years of collaborative development with trial sites at the Medical University of Graz, the Phoenix CTMS now becomes publicly available (LGPL 2.1). This unmatched feature set is geared to support all operational and regulatory requirements of the clinical front end in academic research, at CROs (Contract Research Organisations) and hospitals conducting clinical studies of any phase. want a CDMS that gives you unlimited Javascript form scripting support (server- and browserside). You need to deal with large eCRFs (electronic case report forms) want to try a serious open source alternative for eCRFs. Need to formulate complex ad-hoc database queries to list matching subject candidates using set operations. Conduct several trials in parallel and need to organize site staff and resources. Need a software to implement various processes for ICH GCP.Starting Price: $1 one-time payment -
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CSAM Studies
CSAM Health
CSAM Studies (previously MedSciNet Studies) is a secure, highly customizable online environment with a 20-year track record of successfully hosting clinical studies and trials of all scopes and sizes. A web-based platform for medical research, Studies offers a sophisticated online application package for hosting, maintaining, and monitoring projects of every size and complexity. CSAM MedSciNet’s standard Studies solution features the complete set of components required for setting up a fully functional study or clinical trial. The benchmark solution provides support for rich and interactive data entry forms and flexible workflow structures, as well as advanced data validation, analysis, and exporting capabilities. -
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TrialKit
Crucial Data Solutions
Founded in 2010, Crucial Data Solutions (CDS) provides the most innovative low-code/no-code data and clinical trial management technology on the market today. TrialKit, our cloud-based platform available via both a web and native mobile app, enables end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharm companies of all sizes. Design and deploy validated studies in days not weeks using our intuitive study builder that requires no programming. Thousands of global users have leveraged the flexibility of TrialKit to deploy over 8,000 studies across all phases of development, including Verily (a subsidiary of Alphabet), ICON, Catalyst Clinical Research, SISCAPA Assay Technologies, CDx Diagnostics, and Optinose, and many more.Starting Price: Upon request -
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UNITY
RAYLYTIC
AI-powered medical image analysis meets advanced clinical data process automation. Available as web-based SaaS or an on-premise solution, UNITY is trusted worldwide by major medical technology manufacturers and hospitals to collect complete, consistent, and compliant data. The integrated modules for PROM, eCRF, and medical image analysis streamline key data collection activities to enable faster, cost-efficient trials. RAYLYTIC's Imaging Core Lab possesses decades of experience in the high-precision, automated, independent evaluation of musculoskeletal morphology and device performance in spine, hip, and knee to offer clients unparalleled analytic and operational support. -
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DFdiscover
DFnet
DFnet is a healthcare technology company that provides eClinical solutions, including electronic data capture, eSource, and data management services. We bring more flexibility, better data quality, and greater efficiency to clinical trials everywhere in the world. Collect data from any source – paper crfs, EDC and other electronic sources, online/offline tablet and ePRO entries. Install within your controlled premises or allow us to host in our secure cloud environment. Accelerate SDV and RBM processes with advanced optical recognition that shaves time off manual data entry. Built for maximum flexibility of multi-center studies. Web-based data capture from any source is instantly available in a centralized real-time platform. -
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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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Track.Health
Pryzm Health
Secure and user friendly cloud-based EDC platform for managing clinical trials and studies of all sizes and complexities: ePRO, eConsent, eCOA, eSource, PROMs, PREMs, functional health assessments and participant education/engagement.Starting Price: $1/participant/month -
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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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Castor EDC
Castor
Castor is an Electronic Data Capture system for medical research. Built by researchers, for researchers, Castor is an easy to use, complete, and affordable solution that offers all the capabilities researchers expect from an EDC, and more. Top features include self service eCFR creation (form building), randomization, ePro (patient surveys), monitoring, easy import and export of data, EHR data importer (HL7 FHIR based), audit trails, user management, and much more.Starting Price: $100.00/year -
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Cenduit IRT
Cenduit
Today’s Interactive Response Technology (IRT) systems are increasingly complex. Flexible and configurable IRT matters - with IRT data as the source of record for recruitment, clinical trial drop-out rates, patient visits, and other crucial data. Choose a platform that’s user-friendly, mobile-ready, and comprehensive - embedded in quality, flexibility and expertise. Choose comfort with complex therapeutic expertise in today’s risk-based eClinical environment. Combining the right technology, subject matter expertise and commitment to service we empower clinical trials to deliver patient outcomes. Deep clinical and supply chain knowledge drives innovation and provides clients with control over their Randomization and Trial Supply Management (RTSM) processes. Our innovative suite of tools drives distinctive levels of quality control, site efficiency and patient compliance. Our IRT platform can meet the needs of almost any study, enabling fully validated deployment in as little as 30 days. -
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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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KLINDAT
Sofpromed
Clear design, intuitive, very easy to use, quick data entry and navigation, access control and SSL encryption, fully web-based, no installations required, built-in monitoring, data management and reporting tools, monthly flat rate (SaaS) adjusted to study size and duration. Fast data collection via a user-friendly web interface, review of data completion status through visual indicators, edit checks, automatic and manual queries to detect discrepancies, source data verification (SDV) and remote reviews with integrated buttons, tracking of changes including author, date, time and reason of modification, generation of datasets (E.G. CSV) for statistical analysis. -
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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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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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Clinevo OneQMS
Clinevo
Clinevo OneQMS is a cloud-based quality management system that enables organizations to manage quality and compliance processes digitally. Clinevo OneQMS is an interactive platform to manage all quality and compliance processes of an organization. OneQMS enables organizations to manage documents, training, change, CAPA, and audits in one place. It can be accessed with basic internet/intranet using IE, Chrome, and Firefox browsers. Provides powerful and actionable dashboards and reports for real-time monitoring and tracking of quality and compliance. Business, quality, IT teams, and others can be trained on the Clinevo within a few hours. Clinevo OneQMS complies with all current and emerging regulations. It ships with an inbuilt training management system to efficiently manage the organization’s training processes. It is the best QMS software and comes with transparent optimized pricing. -
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Over the last several years, the Life Sciences industry has faced nearly $15 billion in fines and compliance-related settlements, making it critical for companies to adhere to pharmaceutical, medical device and biotech best practices. Efficient and effective management of clinical trials can also significantly impact the time, scope and budget for the development of a drug or medical device. With OpenText™ Clinical Trial Quality Management System (ctQMS), companies can remain compliant, reduce costs of records management and establish best practice through collaboration before, during and after the clinical trial lifecycle.
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BizNet
Sarjen Systems
Consists of clinical trials management solution suites for various CROs, Pharmaceutical, Biotech and Medical device industries. BizNET-CTM, is a multi-functional platform which allows a CRO (Contract Research Organization) in planning, managing, designing, executing, monitoring and analyzing trial related activities and data in adherence to the protocol obligations and regulatory requirements. An end-to-end solution suite which cater to the needs of clinical research project starting from Project Management, feasibility assessment, volunteer or patient enrollment using iris recognition technology, capture clinical trial data, multi-level review process, data compilation to data archiving. The BizNET-CTM suite is designed to manage all of the documents, tasks, processes, relationships, audits, and training that must be administered and controlled throughout the life of a clinical trial. -
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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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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 TrialPoint’s electronic patient-reported outcomes (ePRO) module which can be configured to fit any quality of life questionnaire or patient diary. -
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ePharmaSolutions
ePharmaSolutions
At ePharmaSolutions, we are building something new. We are not a high-tech company. We are an idea company whose thinking is highly entrenched in technology, but not limited by it. We support the drug development industry with solutions that improve the identification, activation, training and management of clinical trial sites. With new perspectives on old problems, we deliver technology-enabled solutions that help to “un-complicate” the chaos of clinical trial management. ePharmaSolutions (ePS) is a leading provider of e-clinical solutions that improve the way that clinical trial sites are selected, trained, activated, and managed. By applying fresh thinking to old problems, we deliver clever, technology-enabled solutions that empower sponsors, contract research organizations and investigator sites to “un-complicate” the chaos of clinical trial management.