Ofni Clinical Alternatives

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.

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.

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.

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.

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.

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.

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.

Maximize data quality. Ensure data quality by capturing eSource data directly during the patient visit. With built-in edit and validation checks, users capture high-quality data electronically, dramatically reducing errors and queries—and delivering data for real-time, remote monitoring. Reduce study time, cost and risk. Promoted and endorsed by the FDA to streamline and modernize clinical trials, purpose-built eSource eliminates slow, error-prone and inefficient SDV and transcription into EDC systems. Streamline site, study efficiency. Designed with site users in mind, ez-SourceDocx streamlines workflows, reduces workload and ensures protocol execution by guiding sites through properly sequenced visit procedures that guarantee all end point data and prompt quality investigator evaluation.

Clinical Conductor CTMS is a cutting-edge clinical trial management system (CTMS) designed for hospitals, research sites, asset management companies, site networks, health systems, and contract research organizations (CROs). This cloud-based solution helps make the clinical trial process more efficient, thereby helping research organizations make better business decisions and meet every challenge. Key features include electronic data capture, study planning, enrollment management, document management, recruiting management, and more.

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.

ClinAccess™ 5.1 is the next generation of our industry leading Clinical Data Management System based entirely on SAS® 9. It leads the way in simplifying clinical data management, clinical trial analysis and preparation of electronic submissions. Having your data keyed directly into SAS® data sets enhances your staff’s productivity by eliminating the time spent transfering data from Oracle/SQL into SAS. ClinAccess™ is designed expressly for ease-of-use study definition, data entry and management with features to monitor the progress and quality of ongoing clinical trials. Whether for review, analysis, or FDA submission, your data is always in SAS®and ready for analysis. The database structure is designed to support and accelerate statistical analysis and reporting. The result is less time and effort for data analysis and a shorter time to market. For reliability, auditing and security, there is no better solution than ClinAccess™.

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.

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.

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.

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.

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.

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.

See our quick screening tools to identify high-risk patients for breast, colorectal and other cancers. Progeny Clinical simplifies the process of managing family history, assessing risk and determining treatment options for your patients. Obtain family history data from patients online and auto-generate pedigrees before the clinic visit. Edit or create new pedigrees anytime. Run validated hereditary cancer risk assessment models at the touch of a button without re-entering data. Save time by ordering genetic testing from Ambry Genetics. Track and review results from any lab without ever leaving the software. Save time - create letters, consult notes, reports, and documents from custom templates that include patient data fields. Use pre-configured or custom data entry screens and quickly generate custom queries and spreadsheet reports. Add a hyperlink within your electronic medical record to easily display the patient’s most recent pedigree.

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.

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.

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.

A Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC) all in one powerful, integrated solution. All your study information can be at your fingertips with our innovative, flexible and compliant Clinical Trial Software System. Our servers or yours. Clindex® can be installed on your servers or it is available on the Fortress Medical Cloud (SaaS – Software as a Service). Cloud access is available world-wide and your data is securely stored at a SOC 3 certified data center. You can build, we can build. Clindex® provides all the tools you need to develop your own study database. Our quick start manuals and help documentation walk you through the process, step by step. Or our Clindex services team can develop a study for you.

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.

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.

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.

Deep 6 AI disrupts the clinical trial enrollment process by transforming the way researchers identify eligible patients. Using artificial intelligence and natural language processing to mine structured and unstructured patient data, DEEP 6 AI finds more, better-matching patients for trials in minutes, not months. Deep 6 AI works with some of the most prominent health systems, pharma companies, and CROs in the world --making the DEEP 6 platform a crucial step in their clinical research workflow and greatly accelerating patients’ access to clinical trials. Deep 6 AI finds more patients for clinical trials in minutes rather than months, getting life-saving cures to people more quickly. Deep 6 AI’s software analyzes structured data, such as ICD-10 codes, and unstructured clinical data, including doctor’s notes, pathology reports, operating notes and other important medical data in free-text form that cannot be searched easily.

In-system protocol & its a training program. Equipped with fingerprint attendance. Cronos provides highly customizable if/workflows capable for conducting derma/ patch/ other BA-BE/ early phase studies. Capture, cleanse and efficiently manage your study data from paper-based or EDC-based trials. Extract data in desired datasets following standards like CDISC (SDTM). EDC tool with real-time activities. It’s Bedside Data Collection capabilities help in paperless & faster assessments. It comes with a sample inventory & tracking facility as well. Compliance-ready data repository.The facility of data e-printing from almost all BA instruments/software and online review of data in defined workflow with e-stamping and e-signature.Project-wise view, export & archival of data. Generate high-quality statistical reports (tables, listings & formats) in fixed/desired formats with ease.

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.

Data comes at you from all directions – EDC, EHR, smartphones, mobile devices, central laboratories. Prism assimilates data from these disparate sources and transmutes them into information and ultimately knowledge. Prism EDC combines ease-of-use with innovative features to provide a fresh solution for the collection and management of clinical trial data. Prism offers more that than form-based data collection, it aggregates and manages data from a myriad of data sources. Prism eSource is an innovative software solution that allows research teams to extract clinical trial information directly from a site’s electronic health record (EHR). This creates efficiencies and cost savings beyond the current paradigm where sites must enter the same data in multiple systems and accelerates the delivery of novel therapies to patients.

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.

Popsipen is a unique Digital Pen and Paper Technology. It captures the handwriting and transfers it to a database via a USB or Bluetooth connection. As easy to use as a regular pen, this device is a very user friendly way of transferring secured data in real time, on a global scale. We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications specific to the pharmaceutical industry. Our flexibility and experience in the pharmaceutical market, while always maintaining a cost-conscious approach, differentiates us from other CROs. We are able to respond to the changing requirements of the study without time-consuming CRO bureaucracy and delayed deliverables. We have a unique profile for a CRO providing distinctive and innovative dual expertise by combining clinical research implementation with the development of customized IT applications.

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.

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.

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.

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.

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.

A simple and powerful CTMS for hospitals, site management organizations and small CROs with focus on budgeting, finance tracking and reporting. Clinicubes CTMS offers various types of useful special features that help companies successfully manage and conduct every aspect of the clinical trial. The centralized management of trial database provides the most actual information and allows better productivity. Aggregate, systematize and reorganize physicians and healthcare service institutions database. Collect, evaluate and analyze data from multiple studies and different locations on a single report. Provide with reporting options of how the trial is being carried out against pre-set criteria and targets. Communicate study performance data and other operational reports, through interactive dashboards.

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.

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 Datimbi Platform is ideally suited for applications where you need to collect large amounts of complex-structured data from many collaborators or data sources, have built-in quality assurance controls, be able to monitor and control quality and collection processes in real-time, and perform reporting and analysis. And you need to set things up FAST. Our platform is optimized for solutions such as eCRFs for Clinical Trial Management, Social Case Management, econometric event study analysis, or any other workflow-driven data collection and processing. If your need falls into one of those categories, you can usually be fully deployed and operational on the platform within one week! etting up roles, workflow transition statuses, complex data collection forms, processing rules, lists of values, change tracking rules, and custom email alerts is all performed through an easy-to-use web interface. These tools can be managed by your trained staff or via a service from Datimbi.

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.

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.

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.

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).

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.

With over 20 years of experience in both software edition and clinical research sectors, Arone provides clinical research organizations with a complete suite of tools for patient data entry and management. Our solutions are turnkey and our team provides you with personalized support for the proper conduct of your projects and studies. Collect and manage patient data in a single tool. Arone manages the randomization of patients by randomly assigning study participants a type of treatment in order to remove bias in the study. Empower participants of clinical trials for their daily data entry. Benefit from a customized support for your projects.

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.

Introducing the new eTMF Connect. Simplicity Without Compromise. We’ve re-engineered eTMF Connect for a faster, more scalable and higher performing eTMF solution for today and tomorrow’s clinical trial environment. Improved Data Visualizations & Reporting Views. Montrium now offers a range of new data visualization and reporting tools embedded into eTMF Connect, providing more powerful business intelligence applications. With functionality that provides better insight across all of your studies, project teams and clinical operations managers can have increased visibility on TMF completeness, quality, and timeliness. Together, these improvements will elevate your TMF strategy across clinical programs. No clinical trial is the same, and the subtle nuances and regional differences add layers and layers of complexity that can keep even the most experienced TMF professional up at night. Your eTMF platform needs to be flexible enough to manage these differences and nuances.

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.

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.