Alternatives to Protocol First

Medrio's Electronic Data Capture (EDC) platform and complimenting eClinical solutions such as ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have been trusted by major pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic companies since 2005. We are known for our easy-to-use solutions, delivering speed and simplicity to clinical trials of all phases, sizes, and complexities. Medrio users can build their databases in an average of 2.8 weeks with no programming required, make mid-study changes with just a few clicks of a mouse, and much more. From bolt-on capabilities to full-service offerings, Medrio offers flexible, modular solutions that give our customers exactly what they need – and none of what they don’t. Our 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.

In a matter of hours, you can create an eCRF that is just as easy to use and as simple as a paper one. This will help you avoid the most common problems in data collection for Pre-authorisation and post-authorisation studies. When creating an eCRF, make sure you have an EDC that is flexible. This will allow you to adapt to any type of study. The EDC includes a number of monitoring and management tools that will help you save a lot of time and effort in managing and monitoring the study. You should use a valid system that gives trust to the sponsor and allows for the collection of high quality data. Do not wait until the analysis phase to find errors in the data. Otherwise, you will have to chase down investigators to correct them. Avoid making the process of creating an eCRF long and complicated.

Castor offers an intuitive and comprehensive platform for managing clinical trial data, focusing on electronic data capture (EDC), eConsent, and patient-reported outcomes (ePRO). The platform is optimized for decentralized trials, providing seamless tools for remote patient engagement and data collection. With real-time reporting, Castor helps researchers track trial progress and make data-driven decisions. The solution ensures compliance with industry regulations such as HIPAA, GDPR, and 21 CFR Part 11, making it ideal for life sciences organizations looking to enhance trial efficiency while maintaining high data integrity.

OpenClinica is a leading provider of clinical data management software solutions. OpenClinica provides powerful tools to ensure that clinical trials are compliant and efficient. OpenClinica Enterprise, OpenClinica Participate and OpenClinica Randomize are the core products. OpenClinica is a powerful clinical trial platform that offers a wide range of tools for data collection, patient engagement, and study management. From electronic data capture (EDC) and eConsent to patient recruitment and real-time reporting, OpenClinica’s solutions automate and simplify the clinical trial process. With features like EHR-to-EDC integration and advanced reporting dashboards, the platform improves data accuracy, reduces delays, and enhances compliance. OpenClinica has been used in over 15,000 clinical studies, providing support for organizations around the globe, including government agencies and pharmaceutical companies, to conduct trials with confidence.

ClinCapture's mission is to create software that saves lives. ClinCapture's technology reduces the cost of clinical trials. It streamlines data capture and protects patient privacy. Clincapture is a platform that facilitates the evaluation and development drugs, biologics and devices that have the potential to treat a wide variety of medical conditions or diseases.

Complex eClinical Solutions for EDC/ERT/eCOA significantly speeds up the start and completion of clinical trials (up to 5 days), reduces costs (up to 80% for monitoring), and increases capitalization and attractiveness (recognized by 89% customers). 96% of data science specialists say it increases the knowledge and advancements of Data Management and Data Science professionals. 94% of investigators love interfaces' usability. Strong internal competence in Data Management 365 is an important part of the Data Management 365 policy. This allows us to not only better understand the challenges faced by Data Managers and improve the MainEDC™, but also to transfer technology and best practices to our clients.

The integration of eCOA and digital technologies is paving the way for the future of clinical research, seamlessly connecting traditional methods with innovative, patient-centered approaches. Choose YPrime's eCOA solutions to not only obtain high-quality patient data but also to enhance the overall user experience for sponsors, investigator sites, and patients alike. By employing a flexible software development strategy, YPrime is able to swiftly tailor and adapt functionalities to meet specific study requirements within an impressive timeframe of 8 to 12 weeks. Our engaging and visual design process allows clients to review the system at various stages of development, ensuring they are informed before the system goes live. Additionally, our pre-validated and customizable authoring environment not only streamlines startup timelines but also accommodates post-production adjustments, such as changes to study protocols, making it an indispensable asset for clinical research. This commitment to agility and responsiveness positions YPrime as a leader in the evolving landscape of clinical trials.

H1 Universe is an innovative platform that leverages artificial intelligence to enhance the management of healthcare data, offering users access to the most extensive global database of healthcare providers (HCPs). By merging information from various sources, such as public, private, and proprietary databases, H1 Universe provides valuable insights that are crucial for clinical trials, medical affairs, and commercialization efforts. This powerful tool enables healthcare teams to pinpoint essential stakeholders, refine clinical research processes, and make informed decisions swiftly, ultimately boosting overall efficiency within the healthcare landscape. Furthermore, the platform not only aids in real-time decision-making but also fosters collaboration among healthcare professionals, paving the way for improved patient outcomes.

Mosio allows research teams to improve subject adhesion, communications, data collection, and communication on mobile's most popular channel, text messaging. Our software helps research teams communicate more efficiently with participants by delivering interactive elements to mobile phones and messaging automation. WHO CAN WE HELP? + Clinical Trial Sponsors (Pharma & Biotech) + Cancer Centers and Clinical Research Organizations + NIH-Funded Studies + Public Health Agencies + Clinical Trial Managers/Directors and Clinical Operations Managers/Directors. Clinical Project Managers. Principal Investigators. Clinical Research (Study). Coordinators. All research staff who regularly communicate with study participants. BENEFITS + Interactive medication reminders and medication compliance alerts + Automate data collection. + Increase engagement and adherence. + Get SMS appointment reminders to fix your no-show problem. + Increase retention with automated check ins

TrialKit is a cloud-based platform available via both a web and native mobile app, enabling end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharma 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.

DSG, Inc., a global leader in eClinical, offers a complete suite of innovative technology solutions as well as data management services to the global clinical research community. DSG's eClinical platform offers a competitive advantage and on-time delivery. DSG solutions have been used in thousands clinical trials across the globe using our award-winning eCaseLink™, platform and eCaseLinkDesign for enterprise licensing. The company was founded in 1992 and is proud to have been awarded the SCDM Data Driven Innovation Award.

Mednet is an eClinical technology company that specializes in healthcare solutions for the global life science community. Mednet's flexible, EDC-centric eClinical platform increases the efficiency of clinical research of all sizes. Mednet's comprehensive solution suite provides all the tools necessary to create and manage clinical research. It can also adapt to changing demands and requirements. Mednet has been trusted by CROs in every sector of the pharmaceutical, medical device, and biotechnology industries for almost 20 years. They provide the expertise, reliability, and innovation that they need to succeed. Mednetsolutions.com has more information.

Signant Health operates as a worldwide leader in evidence generation, striving to transform the landscape of clinical trials by connecting with patients in their environments and rethinking the route to validation. Their extensive range of clinical technology solutions includes electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and a cohesive eClinical platform. Additionally, they offer patient engagement solutions featuring a user-friendly app, eConsent for informed consent processes, and telemedicine functionalities. Furthermore, Signant Health delivers clinical data and analytics services, which include COA data analysis as well as the aggregation and interpretation of data. With a rich history spanning over three decades, they have played an instrumental role in supporting numerous trials and have been pivotal in hundreds of drug approvals, establishing themselves as a reliable ally for sponsors and CROs eager to provide high-quality data for informed trial decisions and regulatory submissions. Their commitment to innovation continues to shape the future of clinical research.

Dacima Clinical Suite, the most advanced web-based solution, combines electronic data capture (EDC), medical data management software (CDMS) and clinical trial management software into one platform. Dacima Clinical Suite is designed for clinical trials, epidemiological studies, web randomization, ePRO, surveys, and patient registers. Dacima Clinical Suite comprises three core modules: the Manager (Administrator), Designer Module, and the Data Entry Module.

Achieve a comprehensive understanding of your research operations by utilizing a robust and standardized clinical trial management system that has been developed in partnership with prominent academic medical and cancer centers. Streamline billing designation processes to promote uniformity across various teams and systems. Enhance your budgeting strategies, ensure accurate routing of charges, and perform more effective audits and monitoring of billing compliance. This integrated approach provides deep visibility and insight into all elements of clinical research, particularly in financial management, thanks to collaboration with elite research institutions. Moreover, by connecting OnCore with your existing electronic medical records (EMR), including seamless integrations with Epic and Cerner, you can significantly boost patient safety, minimize redundant data entry, improve billing compliance, and elevate overall operational efficiency. Ultimately, this system not only simplifies processes but also fosters a more effective research environment.

Data management is crucial to the success and efficiency of your clinical research. Despite being complex, Quanta View, an e-CRF, makes it possible to control the processing of your data. Quanta View includes elements such as monitoring, follow up of inclusions, and project management. The application will be there to help you in all aspects of your clinical research. It is accessible via the internet and responsive. It adapts to all media (tablet, laptop, etc.). Quanta view is designed for the pharmaceutical, medical device, and cosmetic industries.

If you are engaged in clinical research, you are likely aware that gathering data can be a significant drain on your time and can easily become disorganized, particularly when relying on paper forms. This is precisely why we developed Teamscope: to streamline the process of collecting research data, ensuring its security while allowing for instant analysis. Our goal is to alleviate your concerns regarding research data management, giving you more freedom to focus on the aspects of your work that you truly enjoy. Transitioning from paper-based data collection to an electronic system with Teamscope is quick and straightforward. Our online form builder enables you to tailor your survey forms using 11 different types of fields. Additionally, the skip logic feature allows you to reveal or conceal fields based on user input, thus facilitating the creation of dynamic survey paths. With skip logic, you have the flexibility to design intricate pathways tailored to your research needs, and our team of specialists is available to assist you in constructing even the most sophisticated forms on Teamscope. Ultimately, this innovative tool not only enhances your data collection experience but also empowers your research endeavors.

At Calyx, we understand that the foundation of a successful clinical development initiative lies in the quality of your data, which underscores the importance of an efficient electronic data collection (EDC) system. Employed in over 2,600 clinical trials globally, Calyx EDC facilitates the streamlined collection and reporting of clinical trial data through a user-friendly platform. It’s essential to safeguard your critical data with a reliable partner—reach out to us to discover how Calyx can enhance the success of your program. With Calyx EDC, you gain the adaptability to effortlessly plan, design, and execute studies of any complexity. Its features are crafted to lower costs, enhance site visibility, and boost efficiency, ensuring your trial remains on course. Trust Calyx to be the ally you need for navigating the complexities of clinical trials.

EvidentIQ's eCOA streamlines the collection of real-time, direct-from-patient data through an easy-to-use interface that facilitates sophisticated patient assessments, ultimately enhancing both the patient experience and the quality of the data gathered. Clients have the option to choose a complete, all-inclusive eCOA solution or to mix and match various components tailored to their specific needs. By scheduling a demo with our knowledgeable team, you can discover how to maximize the return on investment for your research studies. The eCOA platform merges data science services with technology to provide a versatile solution. It operates independently of particular eClinical technologies like EDC systems, while also offering seamless integration with existing eClinical software ecosystems. Designed to efficiently gather a wide range of outcome data reported by patients, clinicians, or observers, this solution ensures compliance and enhances the overall data collection process. With such flexibility, organizations can adapt the eCOA framework to suit a variety of clinical trial scenarios, enhancing their research capabilities significantly.

When compared to other Electronic Data Capture (EDC) solutions available from companies like MediData, DataTrack, and Omnicomm, TrialStat stands out as the most comprehensive suite of study management tools that can effortlessly integrate with various external data sources, including electronic medical records (EMR), wearable devices, and both clinical and non-clinical information systems. TrialStat presents a cohesive platform that caters to all phases and categories of clinical trials. Our EDC suite is designed with a single sign-on feature and supports multiple tenants, incorporating modules for Randomization, Adjudication, Coding, Safety, Patient Diaries/ePRO, a Vendor Neutral Imaging Archive, an extensive Reporting and Analytics Portal, and tailored Machine Learning applications. With an emphasis on data analysis, TrialStat provides real-time reporting capabilities, on-demand data extracts, and analytics that span a single study, a program, or the entirety of your research portfolio, ensuring that all stakeholders receive pertinent, customized, and timely insights into every facet of study data while pinpointing areas of risk or potential delays. Additionally, the platform’s integration capabilities allow for improved collaboration among research teams, fostering a more efficient and effective trial management experience.

Jeeva's patent-pending modular system is built on the most powerful cloud platform. One login from any browser-enabled device can be used to remotely screen patients, educate, enroll, send SMS, email and generate evidence including electronic patient-reported outcomes. They are tired of waiting for patient recruitment and retention to happen. It is crucial to provide sufficient evidence of safety and efficacy for investigational new medicines in order to receive regulatory agency approval. Jeeva is a great tool for saving time and money for patients, biopharma sponsors, and long-term follow up studies for gene therapy.

Zelta is a cloud-powered platform for unified clinical data management and acquisition, designed to streamline and enhance clinical trial processes. Its modular architecture adapts to the unique demands of each study, enabling faster and more efficient outcomes. With capabilities such as electronic data capture, clinical operations management—including randomization and trial supply tracking—clinical trial management, and electronic trial master file functionality, Zelta supports comprehensive study oversight. It also enhances patient and provider engagement with electronic clinical outcome assessments and e-consent solutions. Built for studies across all phases, therapeutic areas, and global regions, Zelta offers an intuitive user experience with secure single sign-on access from anywhere. Its flexible and scalable design allows for seamless customization and integration with both native and third-party technologies, ensuring adaptability to diverse research needs.

Replior is a pioneering company specializing in software solutions for clinical trials, featuring an integrated platform that encompasses EDC, eConsent, ePRO, and Virtual Visits to enhance trial execution. Our comprehensive system, known as Trial Online, facilitates the seamless collection and management of data from investigators, participants, and wearable devices in an efficient manner. It is designed to accommodate decentralized clinical trials (DCT), allowing for flexibility with site visits, remote interactions, or a combination of both. Our journey commenced two decades ago when we were approached to create an online CRF service for a major pharmaceutical firm, marking our transition from an IT operations provider to a dedicated software developer for clinical data collection. Over the years, we have expanded our offerings to include a complete suite of data collection services, while our IT operations are expertly managed by our highly qualified sister company, Complior. As we continue to innovate, our commitment to enhancing clinical trial processes remains at the forefront of our mission.

Data MATRIX offers a comprehensive SaaS solution specifically designed for clinical trials. Since its inception in 2009, the Data MATRIX team has specialized in the processing and analysis of clinical data, creating documents that comply with the standards set by the Russian Ministry of Health, FDA, and EMA. Our software streamlines clinical trial processes, allowing users to efficiently manage and track progress online. Before launching a project, we meticulously adjust and validate our software to ensure that every aspect is considered for optimal performance. With a proven track record of completing 180 projects for pharmaceutical companies, biotech firms, and CROs, our solutions have led 6 out of the top 10 Big Pharma companies to achieve a 15% reduction in R&D expenses. Our dedicated team members take pride in their involvement with professional organizations that connect clinical data professionals such as CDISC, ACDM, SCDM, biostatisticians like ISBC, and medical writers associated with EMWA and AMWA. By continually enhancing our offerings, we remain committed to driving innovation in the clinical research landscape.

Fusion is Axiom’s proprietary, cost-effective and easy-to-use eClinical solution. It is aimed at small to medium-sized device, pharma and biotech companies. Axiom's Fusion eClinical Suite allows you to add-on any Modules that meet your study needs. Are you running a small study? You can choose the base configuration with EDC and DM, as well as AE/SAE tracking. Are you looking for something more? To make managing your study easier, you can include powerful Modules like Inventory Tracking, RTSM, Safety Management. You can save time by electronically capturing your study data - even offline! Once you have an internet connection, your data will sync to your Fusion databases. Real-time records available for subject screening activities. Fusion Safety Database allows you to manage pharmacovigilance events.

DFnet is a company specializing in healthcare technology that delivers eClinical solutions such as electronic data capture, eSource, and comprehensive data management services. We enhance clinical trials globally by providing increased flexibility, improved data quality, and enhanced efficiency. Our platform allows for data collection from various sources, including paper CRFs, EDC, and other electronic systems, along with online and offline tablet entries and ePRO. You can either set up our system on your premises or utilize our secure cloud hosting options. Our advanced optical recognition technology accelerates SDV and RBM processes, significantly reducing the time required for manual data entry. Designed for optimal adaptability in multi-center studies, our web-based data capture system makes data from any source readily accessible in a centralized real-time platform. This capability ensures that researchers can make informed decisions quickly and efficiently, ultimately improving the overall conduct of clinical trials.

Mahalo Health is an integrated digital health platform aimed at expediting the creation of patient-focused digital health solutions and clinical trials. By providing a variety of prebuilt modules, Mahalo facilitates the swift launch of customizable white-label applications that cater to particular therapeutic fields. The platform boasts comprehensive data capabilities, featuring a predictive health engine for forecasting diseases and diagnoses, a behavior modification engine to encourage beneficial patient behaviors, and a notification system that ensures timely communication through push notifications, SMS, or emails. Committed to maintaining high security and compliance standards, Mahalo follows regulations such as HIPAA, GCP, ISO27001, and GDPR. Its extensive range of services encompasses multiple therapeutic areas, including diabetes, cognitive health, cardiovascular issues, musculoskeletal conditions, mental health, oncology, rare diseases, and nonalcoholic steatohepatitis (NASH). Additionally, Mahalo Health empowers healthcare providers with tools to enhance patient engagement and outcomes through its innovative digital solutions.

AI-driven analysis of medical imagery is complemented by sophisticated automation of clinical data processes. Offered as a web-based SaaS or an on-premise solution, UNITY has garnered global trust from leading medical technology firms and healthcare institutions for its ability to gather comprehensive, consistent, and compliant data. Its integrated modules for Patient-Reported Outcome Measures (PROM), electronic Case Report Forms (eCRF), and medical image analysis optimize essential data collection tasks, thereby facilitating quicker and more cost-effective clinical trials. RAYLYTIC's Imaging Core Lab brings decades of expertise in the precise, automated, and independent assessment of musculoskeletal structures and device efficacy in areas such as the spine, hip, and knee, providing clients with unmatched analytical and operational assistance. This advanced capability ensures that medical professionals can rely on high-quality data to inform their decision-making processes, ultimately improving patient outcomes.

Our innovative Smart Protocol system is designed to infuse automation and intelligence into the design of clinical trials using artificial intelligence. This groundbreaking solution is transforming the traditional manual processes that research teams have relied on to create clinical trials. In today’s digital landscape, it is practically impossible for individuals to thoroughly analyze every detail pertinent to a decision. Furthermore, many organizations possess valuable data that often goes untapped, with documents frequently stored in repositories that lack visibility. Consequently, life science companies may find themselves making significant and expensive choices based on insufficient information. Our goal is to transition organizations like yours from a document-centric approach to a more insightful, data-driven methodology. We are redefining the research and planning of clinical trials by eliminating the obstacles that separate data from its end-users. To facilitate this, we gather extensive amounts of trial-related documents from both your resources and the public domain, so you can focus on what truly matters—delivering better outcomes for patients. By streamlining access to critical data, we empower teams to make informed decisions faster and more effectively.

Flex Databases is an innovative, unified, and compliant electronic clinical platform that provides software solutions for clinical trials: pharmaceutical companies and CROs. Our system is composed of: - Clinical Trial Management System - Electronic Trial Master File - Project Management & Budgeting solution specifically designed for the clinical trials industry - Pharmacovigilance System - Learning Management System It was possible to create a flexible platform thanks to our unique experience and a qualified team of more than 100 professionals with a deep understanding the clinical trial process.

g.BSanalyze serves as an engaging platform designed for the processing and examination of multimodal biosignal data, primarily aimed at clinical research and life sciences. Having been available for over two decades, it has gained traction in more than 70 countries worldwide. This software stands out as the most extensive toolkit for analyzing both non-invasive and invasive functions and dysfunctions of the brain, heart, and muscles. Its excellence has been recognized with multiple international awards. The latest version boasts a plethora of new features, including topographic plots, Canonical Correlation Analysis (CCA), advanced filtering options, a cortiQ file importer, enhancements for Result2D, tools for Cortico-Cortical Evoked Potentials, as well as dedicated toolboxes for electrocorticography (ECoG) and transcranial magnetic stimulation (TMS), among others. Additionally, the package includes numerous sample biosignal datasets, such as those for P300, SSVEP, motor imagery, CSP BCIs, Tilt-Table, event-related potentials (EPs), multi-unit activity, continuous flow magnetic (CFM), cortico-cortical evoked potentials (CCEP), and ERD/ERS. Furthermore, it features an interactive and user-friendly graphical interface tailored for the analysis and documentation of EEG, ECoG, EOG, EMG, ECG, spike data, and various physical datasets, all within the MATLAB environment. Overall, g.BSanalyze offers a comprehensive solution for researchers and practitioners seeking to delve into the complexities of biosignal analysis.

Science 37 is a pioneering clinical research organization that focuses on decentralized clinical trials through its innovative Metasite model, which eliminates the need for physical proximity, allowing patients to engage in studies from virtually anywhere. This method significantly broadens accessibility, reaching over 90% of individuals who might be excluded from conventional site-based research, and harnesses the recruiting capabilities equivalent to 20 sites in one location, thereby offering patients the flexibility they desire. The Metasite operates on a proprietary platform that not only streamlines study orchestration but also facilitates the workflow for both patients and research staff, all while efficiently capturing study data without manual reentry. By centralizing personnel, processes, and technologies, this approach guarantees built-in protocol compliance, which leads to enhanced compliance rates and the collection of high-quality data. Science 37's dedicated in-house medical teams, telemedicine investigators, and mobile nursing professionals are well-versed in the conduct of remote trials spanning various therapeutic areas, thus ensuring comprehensive outreach. This commitment to innovative trial methodologies positions Science 37 at the forefront of transforming the landscape of clinical research.

Flask Data equips life science research and development teams with timely clinical data and solutions for patient safety. The Flaskdata.io cloud API platform streamlines data collection applications for patients, researchers, site coordinators, connected devices, and pharmaceuticals. Our offerings in data management and safety oversight are designed to mitigate risks related to clinical data integrity, patient well-being, and adherence to protocols. The Flaskdata.io platform is not only automated but also scalable and responsive to the specific requirements of your clinical trials. Flask Data is a tech firm that focuses on clinical data oversight and management. We excel in delivering optimal solutions that ensure the highest quality of clinical data while prioritizing patient safety. Recognizing that there is no universal solution applicable to all clinical trials, we dedicate ourselves to thoroughly understanding your distinctive challenges. Collaborating closely with your team, we strive to create tailored solutions that meet your needs for high-quality clinical data and enhanced patient safety, ultimately driving the success of your research initiatives.

Welcome to Dotter.science, your go-to online resource for enhancing clinical research. Designed specifically for researchers and organizations conducting health research protocols, Dotter enables you to efficiently execute your study while concentrating on what truly matters. You can effortlessly collect and analyze your clinical research data, making the entire process smoother. With Dotter.science, you can quickly create customized data collection forms and enhance the efficiency of your clinical research databases, simplifying both statistical analysis and publication efforts. Targeted at researchers, healthcare professionals, and students, Dotter significantly improves time management and operational efficiency. Features of Dotter include optimized data collection through an intuitive graphical interface for designing your electronic logbooks (eCRF), allowing for rapid patient inclusion with real-time data consistency checks. Moreover, Dotter's streamlined statistical analysis means you can say goodbye to paper records! Your data is securely stored on certified servers throughout your study and can be easily exported in structured formats, ensuring that your research is both safe and accessible. This platform is not just a tool; it's a comprehensive solution for modern clinical research needs.

CORE (Clinical On-demand Research) provides a variety of specialized services that encompass the design, development, and management of electronic forms utilized in clinical trials both in the UK and internationally. In addition to crafting the necessary forms, CORE facilitates randomization, oversees data management, and supplies crucial study statistics, ensuring researchers have access to essential information. This organization is instrumental in collecting important data for those in both academic and commercial research environments. CORE has established a successful collaboration with FormsVision, which began under an FP7 EU funding initiative, and has implemented the ALEA eCRF (electronic Case Report Form) to enhance trials conducted in the UK and New Zealand. The dedicated team at CORE stands ready to provide an array of services, including database construction for CRFs, management of randomizations, drug supply coordination, and ePRO (ALEA). Furthermore, they offer data hosting solutions for various types of files, as well as expert guidance on funding applications, statistical support, and protocol writing advice. This comprehensive suite of services positions CORE as a vital partner in advancing clinical research efforts.

Management of clinical data. Comprehensive solution for managing clinical trial information. Easy data entry and creation of CRFs. Support for multi-center complex studies. Data validation and processing is accelerated Multilingual capabilities. Global deployment, cloud-based and on-premise. Clinical researchers understand the importance of reducing time and costs when conducting clinical trials. This is especially true when it comes to the collection, processing, and management of study-specific data. To ensure that the necessary patient data was recorded and sent to the sponsor for analysis and processing, study coordinators used paper Case Report Forms (CRFs). The days of paper CRFs are long gone. The industry now understands that electronic data capture (EDC), systems increase efficiency and improve data quality.

Longboat is a cloud-based solution designed to support clinical trials, offering an integrated Guided Compliance toolset that assists users consistently throughout the process. By supplying clinical trial site personnel with essential resources, Longboat enables them to concentrate on patient care. Additionally, it allows participants to access vital study details and receive reminders for upcoming visits. The platform facilitates the streamlined management of any amendments to the clinical trial protocol, ensuring a smooth and controlled rollout. Furthermore, it centralizes the secure sharing of regulated documents among sponsors, CROs, and sites, which significantly enhances the startup process and simplifies traditionally labor-intensive tasks for all research stakeholders. Through a unified support platform, all key participants—including clinical operations teams, monitors, site personnel, and trial participants—can access customized content that addresses their individual requirements. This comprehensive approach ensures that site staff are equipped with the necessary tools and resources to remain engaged and compliant while prioritizing the needs of participants. In doing so, Longboat not only improves operational efficiency but also elevates the overall experience for everyone involved in the clinical trial.

A dynamic statistical software specifically designed for scientists rather than statisticians. You can kick off your analysis by inputting data into tables tailored for scientific inquiry, which will then assist you in selecting statistical methods that enhance your research efficiency without the need for any coding. You'll receive insights and support throughout the entire process, ensuring you make informed decisions about your analyses, grasp the essential assumptions involved, and correctly interpret your findings. With Prism, collaborating with teammates becomes a breeze, allowing you to gather feedback from peers and share your research findings with a wider audience effortlessly. Transition from raw data to sophisticated, publication-ready graphs smoothly and without hassle. Prism provides numerous options to personalize your visual representations, including various color palettes and data organization methods. You can export your work in multiple formats, send it directly to PowerPoint, or email it from within the application itself. Furthermore, you can enhance your skills in data analysis and visualization through exclusive educational resources crafted by seasoned experts in the field, ensuring you are well-equipped for any research challenge. With its user-friendly interface and robust features, Prism empowers you to achieve your research goals effectively.

Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak's unified eClinical solution and related services improve efficiency and cost effectiveness for the clinical trial industry. Datatrak developed its multi-component, comprehensive solution using a single platform. This concept was expanded to include services delivery through Datatrak's Clinical and Consulting Services groups. The Company offers a complete range of software products that can be used to speed up the reporting of clinical research data to sponsors and regulators. This is faster than using loosely integrated technologies. Our goal is to empower workgroups with role-based access, version-controlled file management and calendar events, tasks, and contacts. All built within our eClinical software applications, including EDC, CTMS and reporting.

OpenText™ Information Management solutions empower organizations in the life sciences sector to harness data and content insights, enhancing their decision-making and speeding up product development. These tools enable seamless integration, management, and secure sharing of information among individuals, systems, and devices. By utilizing information assets effectively from research and development through to commercialization, organizations can benefit from adaptable cloud-native software that operates in any environment. OpenText for life sciences significantly accelerates the discovery process, facilitating the extraction of actionable insights that foster innovation in the pipeline. Users can convert research papers into electronic lab notebooks through intelligent capture, and uncover valuable insights using text mining techniques. Moreover, the platform allows for the extraction of knowledge hidden within unstructured text of clinical trial reports, study protocols, and findings related to clinical safety and efficiency. It also offers methods to intelligently analyze, categorize, and extract information from clinical trial documents, ultimately minimizing the risk of expensive delays and interruptions in the development process. By effectively utilizing these advanced capabilities, life sciences organizations can significantly enhance their operational efficiency and drive forward their research initiatives.

uMotif is an innovative platform for eCOA/ePRO and eConsent, aimed at enhancing both clinical and real-world research efforts. Created with input from patients, this platform offers unmatched engagement, significantly improving the speed, quality, and precision of data collection. Through the integration of uMotif's eCOA/ePRO system with real-time glucose monitoring, the platform achieved remarkable compliance rates during a comprehensive diabetes study across Europe. In another instance, an immunology trial benefited from the patient-focused eCOA/ePRO solution, enabling the sponsor to fulfill data requirements a full six months ahead of schedule. Additionally, in a CNS study mandated by the FDA, participants utilized their personal devices to provide submission-ready ePRO data, showcasing the platform's versatility. uMotif's commitment to a patient-first design philosophy emphasizes a deep understanding of the patient experience and the factors influencing their behavior. This expertise not only ensures the development of software that addresses patient needs effectively but also results in extraordinarily high engagement levels for study sponsors, fostering a win-win environment for both parties.

Experience the forefront of eSource, CTMS, and eRegulatory software designed specifically for clinical trial sites. With CRIO’s top-tier electronic source, you can effortlessly capture source data in real-time, drastically cutting down on paper usage by up to 90% while enhancing data quality by 80%. Gain command over your operations through CRIO’s user-friendly Clinical Trial Management System, allowing you to efficiently schedule patients, monitor financials, and optimize recruiting processes. We proudly present cutting-edge electronic regulatory binders, including the innovative first-ever electronic delegation log, all compliant with 21 CFR Part 11 standards. For clinical trial sponsors, you can perform 100% remote monitoring of your sites’ source data and regulatory documents through a secure online portal. Become a part of our extensive network of over 500 clinical research sites worldwide. Our commitment is to facilitate the growth of your business by streamlining your site’s operations, ensuring that your studies can continue smoothly, regardless of whether you're on-site or not. This way, you can focus on what truly matters: advancing your clinical research initiatives.

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. Every interaction and data exchange creates Audit Trails, which provide compliant real-time data visibility across all relevant roles. Our products are modular, highly customizable, and available on the web, iPad, and Mobile App for both Android and iOS. We also support Patient's Own Device (BYOD) and interface with Devices and Wearables. Clinvigilant💊, your one-stop🌐solutions provider for clinical trials☁️ .

Uncover the most cutting-edge methods in the realm of clinical and patient-reported outcomes data. Our comprehensive solution transcends mere data entry, facilitating a genuinely patient-focused research experience. While our eCOA software is deeply rooted in principles of behavioral science, it has also been designed specifically by healthcare professionals to align with the needs of both sites and sponsors. By emphasizing personal identity, motivational intervals, and significant objectives, we stand out from other eCOA solutions. The Datacubed app features a user-friendly interface that allows participants to quickly engage with what truly matters. It has been highlighted that gathering data is now more straightforward than ever, thanks to our adaptable, user-friendly, and interactive application. As the need for flexibility in trial design continues to grow, we provide versatile data collection options that can be executed in person, remotely, or as a hybrid approach, catering to the diverse requirements of traditional, hybrid, and virtual clinical trials. This adaptability ensures that researchers can effectively capture the most relevant data, regardless of the study format.

Entrypoint is an all-encompassing platform designed for the creation, deployment, and management of tailored data entry applications, enabling users to access data entry and system administration functionalities from any location. This suite of intuitive tools empowers users to design, implement, and operate a diverse range of personalized data entry applications, complete with integrated validation, editing capabilities, and export options. With numerous built-in features, Entrypoint simplifies the integration of advanced elements such as range checks and table lookups. The traditional method of gathering information using paper forms and later re-entering it into a digital system is not only time-consuming but also prone to transcription errors. By utilizing electronic forms for direct data entry into a database, organizations can eliminate the intermediary paper process. Furthermore, the transition to electronic data capture becomes increasingly advantageous for organizations dealing with heightened data volumes and escalating costs, as it streamlines operations and enhances efficiency in managing data. In this way, Entrypoint serves as an essential tool for organizations looking to modernize their data handling processes.

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.

Kickstart your project by selecting one of our applications as a base for customization and configuration. If you don't find the right fit, you can always build a new application from the ground up using our user-friendly visual designer. Equipped with robust pre-built components, you have the flexibility to create forms, establish workflows, and design your application through an easy drag-and-drop interface, all without the need for coding! Utilize the intuitive visual designer to develop your study, structuring your database to align with the specific type of research and data collection required. You can easily aggregate and examine your data through tailored screens, ensuring that you can identify discrepancies, manage incomplete submissions, and track follow-ups efficiently. Reorganize your database into easily manageable segments based on your selected criteria, and create filters using natural language for enhanced accessibility. Additionally, leverage saved datasets for comprehensive reporting, workflow management, patient tracking, and in-depth data analysis, ultimately streamlining your project’s processes and improving efficiency.

As a provider specializing in Data Management, we deliver comprehensive services that include both data management and the planning and development of statistical analyses alongside suitable CRF design. We ensure that all necessary documentation complies with FDA standards and other relevant regulations. Our previous experiences indicate that investing more time in the planning stage significantly enhances the overall efficiency and speed of the trial's final phases. Our databases are meticulously created by seasoned data managers who possess extensive knowledge of various eCRFs and understand the essential aspects of electronic data capture system design and data collection. This expertise enables us to construct the eCRF in a remarkably short timeframe. Additionally, the validation and testing of the eCRF are critical components of our design process, handled by separate personnel to guarantee a thoroughly detailed and functional eCRF. By prioritizing these elements, we can ensure the highest quality outcomes for our clients.

LifeSphere EDC offers a budget-friendly solution for sponsors and CROs to efficiently gather, manage, and report clinical trial data, regardless of the trial's stage or complexity. By consolidating various systems into one cohesive database, it eliminates the necessity for expensive integrations and data reconciliation processes. The platform captures clinical information directly from study sites, thereby removing the reliance on paper Case Report Forms (CRFs) and manual data entry. This approach not only shortens study development timelines but also facilitates smooth implementation of adjustments in ongoing studies. Integrated with the LifeSphere Clinical cloud platform, which includes LifeSphere eTMF and LifeSphere EDC, it effectively links operations with data oversight. Additionally, the single sign-on feature simplifies access to a comprehensive suite of applications, while its open architecture promotes swift integration with external applications through APIs. This level of efficiency ensures that clinical research can adapt quickly to changing demands and maintain high-quality data standards.

Our platform offers a web-based interface designed for the efficient collection of data from various types of studies and clinical scenarios. Thanks to its adaptable and user-friendly data entry methods, data can be tailored to suit any medical specialty, patient demographic, or research initiative. The system enhances care quality by monitoring patient-reported outcomes and leveraging population analytics. Its secure, web-based design ensures compatibility with both personal computers and tablets, facilitating seamless data input. Researchers benefit from real-time reporting capabilities, enabling them to oversee the complete study process for both single and multi-site research, independent of their geographical settings. The DADOS Platform features an exceptional user interface (UI) and intuitive tools that empower clinicians and researchers to design programs or studies that effectively connect research and clinical practice. Patients find DADOS appealing due to its straightforward usability and accessibility from anywhere, making it a valuable tool in modern healthcare. Ultimately, this innovative platform fosters a collaborative environment where research and patient care can thrive together.