ClinVigilant Alternatives

Create, in a few hours, an eCRF that is as easy to use as a paper one, and avoid the biggest headaches in data collection in Pre-authorisation and Post-authorisation studies of your medical device. Incorporate an EDC that is highly flexible when creating the eCRF, this will allow you to meet the needs of any kind of study. Save tons of time in the management and monitoring of the study with the management and monitoring tools included in the EDC. Use a validated system with all the security guarantees that give trust to the sponsor and allow the collection of quality data. Don’t wait until the analysis phase to discover mistakes in the data or you will end up chasing down investigators to correct them. Prevent the process of creation of an eCRF from being long and complex.

OpenClinica is a premier provider of clinical data management software solutions. Offering powerful tools for efficient, compliant clinical trials, OpenClinica helps maximize the security, reliability, and compliance of every clinical research. Core products include OpenClinica Enterprise, OpenClinica Participate (helps capture data directly from study participants), and OpenClinica Randomize.

Medrio is on a mission to ease complexity in today’s hybrid, decentralized, and site-based clinical trials by delivering a flexible suite of eClinical technologies and services, including EDC, eCOA, ePRO, eConsent, Direct Data Capture, and Randomization and Trial Supply Management (RTSM). Trusted by CROs, sponsors, and sites across all therapeutic areas and trial phases from study startup and feasibility to post-market approval, we are industry-recognized for delivering eClinical software with intuitive interfaces and time-saving “drag and drop” configurations as well as high-touch customer engagement, onboarding, and support services. Medrio’s innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.

Complex eClinical Solution for EDC/ERT/eCOA that significantly speeds up the start of clinical trials (up to 5 days), saves budget (up to 80% for monitoring), increases the capitalization and attractiveness of your company (noted by 89% of customers). Increases the knowledge and advancement of Data Management and Data Science professionals (noted by 96% of specialists). 94% of investigators like the usability of interfaces. An important part of Data Management 365 policy is to have strong internal competence in Clinical Data Management and Data Science. This allows our company not only to deeper understand the challenges that Data Managers face in their work and make the MainEDC™platform better using the online feedback but also to provide the transfer of technology and best practices to our Clients.

At ClinCapture our mission is to build software that saves lives. Our technology lowers the cost of clinical trials by streamlining data capture processes while providing a platform that protects patient privacy. Clincapture advances the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions.

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.

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.

DSG, Inc. is a leading global eClinical provider with a fully unified suite of innovative technology solutions and data management services for the global clinical research community. DSG's eClinical software platform provides competitive advantage that is cost-effective with on-time project delivery. DSG solutions have been used in thousands of clinical trials around the globe with our award-winning eCaseLink™ platform and eCaseLink Designer for enterprise licensing. Founded in 1992, the company is proud to be recognized as the first provider of a fully integrated EDC and IRT Randomization and Trial Supply Management system with the SCDM Data Driven Innovation Award.

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.

eCOA by EvidentIQ optimizes real-time, direct-from-patient data collection by offering a simple and intuitive interface providing advanced patient assessments to enhance the patient experience and improve data quality. Customers can benefit from an end-to-end comprehensive eCOA package or create value by selecting from the various elements meeting specific requirements. Book a demo with our team of experts and see how you can improve your study ROI. eCOA by EvidentIQ brings data science services and technology together. Customers can benefit from an end-to-end comprehensive eCOA package or create value by selecting various elements meeting specific requirements. The solution can be used stand-alone as it is independent of any specific eClinical technologies such as EDC systems, but it can be integrated in any existing eClinical software landscape. It has been created to collect any patient/clinician/observer reported outcome data in a streamlined, compliant and efficient way.

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.

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.

All-in-one diamond SaaS solution for clinical trials. Data MATRIX team has been working with clinical data since 2009. We process data, analyze it and develop documents to be accepted by the Russian Ministry of Health, FDA, and EMA. Our products automate the processes of clinical trials, and users manage and monitor its progress online. We adjust and validate our software before the project starts and take into account all aspects of the project in order to do it in the best way. Our team has conducted 180 projects for pharmaceutical and biotech companies and CROs. With Data MATRIX products, 6 out of 10 TOP Big Pharma companies reduced their R&D costs by 15%. Our employees are proud to be members of professional communities which unite clinical data specialists (CDISC), data managers (ACDM, SCDM), biostatisticians (ISBC), and medical writers (EMWA, AMWA).

eCOA and digital technologies are the future of clinical research, effectively bridging the gap between traditional and forward-looking, patient-focused development. Rely on YPrime’s eCOA solutions not only for high quality patient data, but for a different and better user experience -- across sponsors, investigator sites and patient users. YPrime employs an agile software development approach to quickly customize and configure functions tailored to the needs of the study in 8-12 weeks. Our interactive and visual build process ensures clients have opportunities to see the system at different stages during design and development, prior to go-live. Our pre-validated, configurable authoring environment facilitates start-up timelines and post-production changes, such as protocol amendments.

An integrated EDC, eConsent, ePRO and Virtual Visit platform for the efficient conduct of clinical trials. Replior is a company providing software for clinical trials. Our suite of systems is called Trial Online and enables collection and management of data from investigators, participants and wearables in an easy and efficient way. Trial Online supports decentralized clinical trials (DCT) by enabling the trials to operate with site visits, remote visits or as a hybrid. We started our journey 20 years ago with a request to build an online CRF service for one of the world’s largest pharma companies, back then we were an IT operations provider for the pharma industry. This was the starting point of providing software for collection of data in clinical trials. Today we offer a full suite of data collection software services, and our IT operation is performed by our, very certified, sister company Complior.

Mednet is a healthcare technology company specializing in eClinical solutions designed for the global life sciences community. Mednet’s flexible, electronic data capture (EDC)-centric eClinical platform improves the efficiency of clinical studies of all types and sizes. Beyond simply EDC, Mednet’s comprehensive solution set provides the tools required to build and manage all types of clinical research, while adapting to evolving demands and requirements. Pharmaceutical, medical device, biotechnology and Contract Research Organizations (CROs) around the world have trusted Mednet for nearly 20 years to deliver the technology innovation, experience and reliability they need for success. For more information, visit mednetsolutions.com.

Flex Databases is an innovative, unified and compliant eClinical platform, providing software solutions for clinical trials: CRO and pharmaceutical companies. Our system consists of : - Clinical Trial Management System, - electronic Trial Master File - Project Management & Budgeting solution, specifically tailored for clinical trials industry - Pharmacovigilance system - Learning Management System Our unique experience and qualified team of over 100 professionals who possess a deep understanding of the clinical trial process made it possible to create a flexible platform.

We know that data management is essential to the success of your clinical studies. Although these remain very complex, it is currently possible for you to ensure the processing of your data thanks to Quanta View, the e-CRF which is perfected according to your expectations. Quanta view has elements such as the creation of eCRF, monitoring, follow-up of inclusions, project management. The application will accompany you from A to Z in your clinical research. Accessible on the internet and responsive, it adapts to all types of media (tablet, computer, etc.) Quanta view is intended for pharmaceutical industries, medical device industries, cosmetic industries, etc. Offer you a comprehensive clinical research service hub, flexible and adapted to a high-performance, demanding and constantly evolving ecosystem.

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.

IBM® Clinical Development provides pharmaceutical, contract research organizations and medical device companies unified technology from start up to submission to support clinical trials. With our clinical data management system, users can organize and analyze report data from anywhere in the world. Enabling pharmaceutical organizations to deliver therapies faster to their patients. Design and launch studies without database migration. Deliver quick and easy remote consent with minimal integration.

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.

Gain visibility into all aspects of your research operations with a comprehensive, proven, and standardized clinical trial management system built through collaboration with leading academic medical centers and cancer centers. Centralize billing designation information to ensure consistency across multiple teams and systems. Improve your budgeting process, route charges correctly, and conduct more accurate auditing/monitoring of billing compliance. Gain visibility and insight into all aspects of clinical research, including comprehensive financial management, with a standardized system built in collaboration with top research institutions. Integrate OnCore with your current EMR, including turnkey interfaces with Epic and Cerner, to increase patient safety, reduce duplicate data entry, enhance billing compliance, and increase operational efficiency.

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.

Protocol First not only bridges physical distance and breaks down the silos in Clinical Research during the pandemic, but our solutions are also suited to “normal times”. Technology that was once nice-to-have, is now a necessity. We provide the tools to stay connected, and not just to continue your research, but accelerate it. A complete remote monitoring tool with auto-tagging capabilities. Works with any EDC, anywhere, anytime. Protocol First has focused on breaking down the silos between Sites, Sponsors, CROs and functional areas. We offer comprehensive solutions to address the many dysfunctions of Clinical Research. Protocol First is built around getting your data right and in the right places. Today and in the future that includes AI/NLP/ML. The most important aspect to AI is making sure your data has an underlying structure. The family of software at Protocol First ensures that your data from patient to FDA is able to leverage the power of data science.

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.

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.

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.

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.

Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, the Viedoc solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offices in America, France, Japan, Vietnam, and China. Since Viedoc's inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. Specialities: Electronic Data Capture, ePRO, Randomization, Medical coding, Logistics, eCOA, reporting, and data management

Clinion eCOA enables you to run decentralised clinical trials with patients participating remotely, using eConsent and patient diary for higher compliance Clinion eCOA allows study participants to report their health using their own smartphones, from the comfort of their homes; allowing clinicians to monitor patients in real-time. Clinion eCOA is fully integrated with Clinion EDC and allows trial participants to input daily outcomes directly, eliminating data duplication and transcription errors and providing clinicians with a real-time view of patient progress. The eCOA app supports multilingual forms that simplify patient engagement and generate cleaner data. The decentralised nature of eCOA allows wider and faster patient recruitment.

GoResearch™ is a fully validated, innovative internet platform for electronic data capture(EDC) created by 2KMM for research projects such as clinical/observational studies andpatients registries. It offers a wide range of features supporting such projects invarious areas such as: configuration of the information flow and the Adverse Events management procedures (including automatic e-mail notifications to safety departments), random allocation to a treatment arm through the built-in randomization module, data collection with the use of individually customized case report forms (eCRF) to meet the requirements of each study, and ePRO, eSource and mHealth data integration through dedicated mobile and/or web applications or flexible application programming interface (API).

Medidata’s Rave EDC (Electronic Data Capture) is the most advanced, robust and secure EDC system for clinical trial site, patient, and lab data capture and management. Rave EDC is the cornerstone of the Medidata Clinical Cloud™, the unified clinical research platform that connects processes, eliminates data reconciliation and delivers cross-functional and cross-study data insights. Centrally manage your users, roles, studies, and sites across all Rave EDC (and other products on the Medidata Clinical Cloud) studies. Eliminate study master data duplication and inconsistencies (e.g., different IDs for the same sites in different applications). Rave EDC is at the heart of Medidata’s unified solution for Clinical Data Capture and Management, enabling aggregation and reconciliation of data from multiple sources, Medidata eConsent, Medidata eCOA, MyMedidata, Rave RTSM, Rave Imaging and Sensor Cloud; and intelligent data review and analysis with Rave TSDV and Medidata Detect.

Prelude is the investigator's preferred EDC system. Built with the end-user in mind, Prelude is the most user-friendly data capture system in clinical research. Focus on what really matters, and spend less time training sites and users in entering, QA'ing, and extracting data from the database. When you work with Prelude, our Customer Success Managers become an extension of your team to help make the database build and support as easy as possible. Additional product offerings include ePRO, Offline, and eConsent. Prelude EDC comes with a drag-and-drop functionality, which helps administrators create electronic case report forms that are configured based on parameters such as entry fields, edit checks, calculations, and more. It allows users to streamline processes for searching, report generation, statistical reporting, and data querying, in order to optimize the preparation of datasets.

As a Data Management provider we offer data management and statistical analysis planning and model development with applicable CRF design. All the appropriate documentation is provided by us according to FDA and other regulations. Previous experience has shown us that putting more effort into the planning phase will give a better, faster and efficient result in the end-phase of the trial. Our databases are generated by experienced data managers who have worked with several eCRF-s and already know the critical parts of the electronic data capture system design and data collection. This allows the eCRF to be built in a short period of time. eCRF validation and testing is compulsory part of the design and is dealt by different personnel in order to receive a hundred-percent elaborated eCRF.

CORE (Clinical On-demand Research) covers a range of expert services which include the design, build and running of electronic forms used in clinical trials across the UK and overseas. Not only does CORE create the forms you need, it also offers randomization, data management and provides you with those all-important study statistics. CORE captures vital data for researchers working both in the academic world and commercial setting. CORE has developed a fruitful partnership with FormsVision, which the Unit first engaged with under a FP7 EU funding framework, and has successfully deployed the ALEA eCRF (electronic Case Report Form) to support trials within the UK and New Zealand. The CORE team offer a range of services which include: Database build. (CRFs, randomisations, drug supply management and ePRO (ALEA)). Data hosting (ALEA hosting for data/videos/images/documents). Expert advice (including funding application, statistics support and writing a protocol advice).

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.

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.

AI-enabled and Integrated Electronic Data Capture (EDC) Software Clinion EDC is the most Integrated Electronic Data Capture System in the Industry making your clinical trials faster and better. Our Electronic Data Capture(EDC) Software accelerates the speed of your clinical trial by reducing deployment time, capturing data faster, timely study close-out, and early data lock – all in a cost-effective manner providing the highest data quality, integrity, and security. Clinion EDC Software integrates all the functionalities you need into one platform, from study setup to data management and reporting. What can you expect? - Quick mid-study changes, no need to rely on tech support or take your study offline. - Accelerates data validation and processing by using form rules like edit checks and skip logic. - Support for complex, multi-center studies - Can be integrated with Clinion RTSM, Clinion eCOA, and Clinion CTMS - easy-to-use interface and AI-enabled features

If you are a researcher doing clinical research you know that data collection can be a huge time-drainer and mess, especially when using paper forms. That's why we created Teamscope: to help you easily collect research data, keep it secure and instantly analyse it. We want to help you worry less over your research data and have more time for the things you love. With Teamscope you can switch from collecting data on paper to electronically in no time. Use our online form builder to customise your survey forms with 11 different field types. Skip logic is a feature that makes it possible to hide or show fields depending on what values are entered. With skip logic you can create alternative paths or branches within a survey. The conditions that create each path can be as complex as you want to make them and our experts are ready to help you build even the most complex form on Teamscope.

The software platform Marvin provides solutions for Clinical Data Management, such as EDC (including IWRS/Drug Management, WebPRO, reporting, etc.), Coding, Composer (CDISC ODM-based study design including SDTM mapping), SDTM visualization, Clinical Document Management (eTMF) and a mobile application for direct communication between Investigators & Patients. Our software and technical services accelerate clinical trials worldwide. XClinical is an international eClinical vendor founded in 2002. Its software platform Marvin provides solutions for Clinical Data Management, such as EDC (including IWRS/Drug Management, WebPRO, reporting, etc.), Coding, Composer (CDISC ODM-based study design including SDTM mapping), SDTM visualization, Clinical Document Management (eTMF) and a mobile application for direct communication between Investigators & Patients. Our software and technical services accelerate clinical trials worldwide.

Entrypoint is a complete system for creating, deploying, and administering custom data entry applications, providing data entry and system administration access anywhere you are. Entrypoint is a suite of easy-to-use tools which allow users to design, deploy, and use a wide variety of custom data entry applications with built-in validation, editing, and export options. Entrypoint has many built-in attributes that make adding advanced features such as range checks and table lookups a simple operation. Collecting information on paper forms to re-enter it later into a computer system is a double-entry process that adds the risk of transcription errors and takes extra time. Entering data directly into a database via electronic forms eliminates the paper step. Switching to electronic data capture becomes an even more compelling choice for organizations who face an increase in data volume and rising costs.

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.

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.

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.

Ethical eAdjudication is an innovative endpoint adjudication and e-clinical software solution. With an intuitive and user-friendly cloud service designed exclusively for study leaders, QA staff, and committee members, Ethical eAdjudication offers the simplest solution to seamlessly manage event database, committee assessment, and disagreement and consensus meetings in a GxP controlled environment. By leveraging Ethical eAdjudication, users are given the opportunity to accomplish independent review and adjudication procedures in an effective, timely, and quality controlled manner.

Our clinical trials management system is suitable for virtually any controlled clinical trial, including randomized trials, with a choice of randomization algorithms. Clinical trial software is easily configured for paper CRF (Clinical Report Form) and provides eCRFs (electronic CRF). The software can be configured to capture data in a vast number of forms and techniques, with specific rules as defined by you, to build in integrity and quality checking. The system can be used for direct Electronic Data Capture (EDC), i.e. eCRF, or to print paper CRFs which could consequently be entered into the system. You can also attach images, audio, video, documents (say consent forms) etc., limited only by the amount of storage available. The system is Double Data Entry enabled and has detailed exception reporting. This includes and option to lock records once they have been matched, to prevent any further changes.

eDeviation supports all the operations for Protocol Deviation assessment and management. From software design and validation to collecting supporting documents and exporting data for the TMF, eDeviation® relieves your clinical team from the risks associated with missing or wrongly assessing one-time or recurring protocol deviations. eDeviation® is part of Ethical’s eClinical Software Platforms Solutions supporting faster and more accurate clinical trials management. Whether your protocol deviation assessments are performed by an independent expert committee or by your study team, our eDeviation® software is configured to exactly match your needs. Forms, workflows and exports altogether contribute to a GxP quality and effectively managed study. Study teams, Investigators’ Sites and Committee Members, when applicable, work seamlessly online in real-time to expedite judgments, consensus and timely completion of the protocol deviation assessments and management.

5thPort is a digital patient education, engagement and eConsent platform. It can be used across individual practices, hospitals, health systems, and in clinical research. The platform utilizes high quality, prescriptive multimedia and teach-back to educate patients and their caregivers on their diagnosis, care plans, risks and benefits of recommended procedures. Once the patient is well-informed, our digital eConsent process helps to facilitate a meaningful conversation with your healthcare provider. With 5thPort, achieve the following results: 1. Save 15 to 20 minutes per consult (without spending any incremental effort) 2. Enhance the patient experience 3. Reduce patient stress on the day of their appointment 4. Empower patients to actively participate in their healthcare conversations with their provider 5. Reduce nurse burnout

With eAdjudication® software managed service, trial leaders have control of timelines, the flexibility to adapt to changing conditions and outcomes, and the ability to monitor trends in provider performance and protocol conformity over the duration of long trials. Avoid hidden costs and timeline breaches in your Endpoint Adjudication Study with the innovative, all-inclusive, managed software service. The eAdjudication® Managed Software Service is the most efficient way for Endpoint Adjudication (CEC) Management. Working with the eAdjudication® platform and Ethical's Staff, study teams, committee members and clinical organizations interact effectively online in real-time in an user-friendly, and GxP-compliant environment, avoiding time-consuming, costly and error-prone manual processes. eAdjudication® all-inclusive services streamline the integration and adoption of EA software throughout eClinical organizations.

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.