Top Protocol First Alternatives

OpenClinica stands out as a prominent provider of software solutions for managing clinical data. Their robust tools are designed to enhance the compliance and efficiency of clinical trials. The main offerings from OpenClinica include OpenClinica Enterprise, OpenClinica Participate, and OpenClinica Randomize, which together facilitate a comprehensive approach to clinical data management. Each product addresses specific needs within the clinical research landscape, making them essential for successful trial execution. OpenClinica is an industry-leading platform that enables more efficient and effective clinical trials by providing a comprehensive range of tools for managing data, patient engagement, and recruitment. Key features include electronic data capture (EDC), patient-reported outcomes (ePRO), and fully automated eConsent, all designed to improve accuracy and streamline study workflows. The platform supports EHR-to-EDC integration, reducing manual errors and accelerating data collection. OpenClinica also offers robust reporting and data analysis tools, ensuring real-time insights into trial progress. With over 15,000 studies powered and more than three million patients involved, OpenClinica is trusted by life sciences organizations worldwide, from pharmaceutical companies to academic researchers and government bodies. Its seamless integration, user-friendly design, and comprehensive features make it an essential tool for advancing clinical research.

Castor is an innovative clinical trial platform designed to simplify data management through electronic data capture (EDC), eConsent, and patient-reported outcomes (ePRO). Its flexible and user-friendly interface allows researchers to collect, manage, and analyze clinical data efficiently across multiple sites and remote patients. Castor’s tools are specifically designed to support decentralized clinical trials (DCTs), enabling real-time data monitoring, remote recruitment, and seamless patient engagement. The platform ensures full regulatory compliance, including HIPAA, GDPR, and 21 CFR Part 11, and is certified for ISO standards. With more than 50,000 global users, Castor continues to improve the speed and quality of clinical trials through integrated, scalable solutions that reduce administrative burdens and accelerate research.

Since 2005, Medrio's Electronic Data Capture (EDC) platform and its complementary eClinical solutions like ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have gained the trust of leading pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic organizations. Our reputation is built on providing user-friendly solutions that enhance the efficiency and simplicity of clinical trials across all phases, sizes, and complexities. Users of Medrio can create their databases in an average of 2.8 weeks without needing any programming skills and can easily implement mid-study modifications with just a few clicks. With options ranging from add-on features to comprehensive service packages, Medrio delivers adaptable, modular solutions tailored to meet the precise needs of our clients, ensuring they receive only the services they require. Our cutting-edge software, combined with extensive training and support resources, has resulted in a remarkable 98% customer satisfaction rating, demonstrating our commitment to excellence in the clinical trial landscape. We continuously strive to innovate and improve our offerings to keep pace with the evolving needs of our users.

Within just a few hours, you can design an electronic Case Report Form (eCRF) that is as user-friendly and straightforward as its paper counterpart. This approach will significantly reduce the typical challenges encountered in data collection for both pre-authorisation and post-authorisation studies. When you set out to create an eCRF, it’s crucial to utilize an Electronic Data Capture (EDC) system that offers flexibility, enabling you to customize it for various study types. Additionally, the EDC comes equipped with several monitoring and management tools that can greatly streamline the study oversight process, saving you both time and energy. It is essential to employ a reliable system that instills confidence in the sponsor and facilitates the gathering of high-quality data. Addressing any data errors only during the analysis phase can lead to complications, as it may require you to track down investigators for corrections after the fact. Therefore, strive to keep the eCRF creation process efficient and straightforward, ensuring that it meets all necessary requirements without unnecessary complexity. By focusing on these elements, you can enhance the overall effectiveness and accuracy of your research.

ClinCapture aims to develop software that has the potential to save lives. Their innovative technology not only lowers the expenses associated with clinical trials but also enhances the efficiency of data collection while ensuring the confidentiality of patient information. Additionally, ClinCapture serves as a comprehensive platform that supports the assessment and advancement of drugs, biologics, and medical devices, which can address a diverse range of health issues. By prioritizing both cost-effectiveness and patient privacy, ClinCapture is dedicated to improving the overall landscape of clinical research.

Advanced eClinical Solutions for EDC/ERT/eCOA markedly accelerates the initiation and conclusion of clinical trials by as much as five days, slashes costs related to monitoring by nearly 80%, and enhances both capitalization and appeal, with 89% of clients acknowledging its benefits. A remarkable 96% of data science professionals affirm that it fosters growth and innovation within the fields of Data Management and Data Science. Furthermore, 94% of researchers appreciate the user-friendly nature of the interfaces. Additionally, a robust internal expertise in Data Management 365 is a crucial component of our Data Management 365 strategy, enabling us to not only gain deeper insights into the hurdles encountered by Data Managers but also to refine MainEDC™ and share valuable technology and best practices with our clients effectively. This commitment to excellence ensures that we remain at the forefront of the industry while supporting our clients' success.

The merging of eCOA with digital technology is revolutionizing the landscape of clinical research, creating a bridge between conventional practices and cutting-edge, patient-focused methodologies. Opt for YPrime's eCOA solutions to secure not only superior patient data but also to improve the overall experience for sponsors, investigator sites, and patients. Utilizing a versatile software development approach, YPrime can rapidly customize and modify features to align with specific study needs within a remarkable 8 to 12-week timeframe. Our dynamic and visually appealing design process enables clients to assess the system at different phases of development, keeping them well-informed prior to the system's launch. Moreover, our pre-validated and adaptable authoring environment not only expedites startup timelines but also allows for modifications after production, such as protocol changes, thereby becoming an essential resource for clinical research. This dedication to flexibility and responsiveness solidifies YPrime's status as a frontrunner in the changing world of clinical trials, ensuring that we remain at the forefront of innovation in the field. In doing so, we strive to enhance the efficiency and effectiveness of clinical studies, ultimately benefiting all stakeholders involved.

H1 Universe stands out as a cutting-edge platform that utilizes artificial intelligence to optimize the management of healthcare data, granting users access to an unparalleled global repository of healthcare providers (HCPs). By integrating data from a multitude of sources, including public, private, and proprietary databases, H1 Universe delivers critical insights that are essential for clinical trials, medical affairs, and commercialization strategies. This dynamic tool empowers healthcare teams to identify key stakeholders, streamline clinical research processes, and make swift, informed decisions, significantly enhancing overall efficiency within the healthcare sector. Additionally, the platform promotes real-time decision-making and encourages collaboration among healthcare professionals, ultimately leading to better patient outcomes and a more interconnected healthcare community. In doing so, H1 Universe not only transforms data management but also elevates the standard of care provided to patients.

Mosio empowers research teams to enhance participant engagement, streamline communication, and gather data effectively through the widely used medium of text messaging. Our platform offers research teams the tools to interact more effectively with participants via mobile devices, integrating engaging elements and automated messaging features. WHO CAN BENEFIT? + Sponsors of clinical trials in the pharmaceutical and biotech sectors + Cancer treatment facilities and organizations focused on clinical research + Studies funded by the National Institutes of Health (NIH) + Agencies dedicated to public health + Professionals such as clinical trial managers, directors, project managers, principal investigators, and coordinators, along with all research personnel involved in participant communication. ADVANTAGES + Engaging medication reminders and alerts for compliance + Automation of the data collection process + Boost in participant engagement and adherence rates + SMS reminders for appointments to reduce no-show rates + Improved participant retention through automated check-ins, ensuring ongoing communication and support. Overall, Mosio serves as a vital tool for enhancing the efficiency of clinical research endeavors.

TrialKit is a versatile cloud-based solution accessible through a web interface and a dedicated mobile application, designed to facilitate comprehensive clinical trial management for organizations involved in medical devices, diagnostics, digital therapeutics, and biopharmaceuticals, regardless of their scale. With our user-friendly study builder, you can create and launch validated studies in just days instead of weeks, eliminating the need for any programming knowledge. To date, numerous users worldwide have utilized the adaptability of TrialKit to successfully launch more than 8,000 studies spanning all stages of development. This platform empowers researchers to streamline their processes and enhance the efficiency of clinical research endeavors.

DSG, Inc., a prominent name in the eClinical space, provides an extensive range of cutting-edge technology solutions alongside comprehensive data management services tailored for the international clinical research sector. With its eClinical platform, DSG delivers both a competitive edge and ensures timely project completion. Their innovative solutions have facilitated numerous clinical trials worldwide, leveraging the acclaimed eCaseLink™ platform and eCaseLinkDesign for enterprise-level applications. Established in 1992, the company proudly holds the SCDM Data Driven Innovation Award, highlighting its commitment to excellence in the industry. DSG continues to evolve and enhance its offerings, demonstrating its dedication to advancing clinical research methodologies.

Mednet is an innovative eClinical technology firm dedicated to delivering healthcare solutions tailored for the worldwide life science community. Their adaptable, EDC-focused eClinical platform enhances the efficiency of clinical research, regardless of project size. Mednet offers a complete suite of solutions equipped with all essential tools for the creation and management of clinical studies, while also being flexible enough to meet evolving demands and standards. For nearly two decades, Mednet has earned the trust of Contract Research Organizations across all sectors of the pharmaceutical, medical device, and biotechnology fields. They deliver the expertise, dependability, and creativity crucial for success in research endeavors. For further details, visit Mednetsolutions.com, where you can explore a wealth of information about their offerings and capabilities.

Signant Health stands as a global frontrunner in evidence generation, dedicated to revolutionizing the clinical trial landscape by engaging patients in their own settings and reimagining the path to validation. They provide a comprehensive suite of clinical technology solutions that encompasses electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and an integrated eClinical platform. Their offerings also include patient engagement tools like an intuitive app, eConsent for effective informed consent practices, and telehealth capabilities. Furthermore, Signant Health specializes in clinical data and analytics services, which involve COA data analysis along with the synthesis and interpretation of data. With over thirty years of experience, the company has been crucial in facilitating numerous clinical trials and has significantly contributed to hundreds of drug approvals, solidifying their position as a dependable partner for sponsors and CROs who aim to deliver high-quality data for informed decision-making and regulatory filing. Their unwavering dedication to innovation is continuously molding the future of clinical research, ensuring that advancements benefit both patients and the medical community at large.

Dacima Clinical Suite stands out as a cutting-edge web-based platform that integrates electronic data capture (EDC), clinical data management software (CDMS), and clinical trial management tools into a single cohesive solution. Tailored for a variety of applications, it effectively supports clinical trials, epidemiological research, web randomization, electronic patient-reported outcomes (ePRO), surveys, and patient registries. The suite features three essential modules: the Manager (Administrator), the Designer Module, and the Data Entry Module, each playing a vital role in streamlining the research process. This comprehensive approach ensures that users have all necessary tools at their fingertips for efficient data management and analysis.

Gain a thorough grasp of your research functions by implementing a comprehensive and standardized clinical trial management system that has been crafted in collaboration with leading academic medical and cancer institutions. Optimize billing designation workflows to facilitate consistency across different teams and platforms. Refine your budgeting methodologies, guarantee precise charge routing, and conduct more efficient audits and monitoring of billing compliance. This cohesive strategy offers extensive visibility and understanding of all facets of clinical research, especially in financial oversight, due to partnerships with top-tier research organizations. Additionally, by linking OnCore with your current electronic medical records (EMR), including smooth integrations with systems like Epic and Cerner, you can greatly enhance patient safety, reduce redundant data entry, improve billing compliance, and increase overall operational effectiveness. This advanced system not only streamlines processes but also cultivates a more productive research atmosphere, ultimately leading to improved outcomes in your clinical initiatives. Furthermore, the integration of these advanced technologies may lead to a more collaborative environment among research teams, fostering innovation and excellence.

Effective data management plays a vital role in enhancing the success and overall efficiency of clinical research endeavors. Although the process can be intricate, Quanta View, an electronic case report form (e-CRF), facilitates streamlined data processing control. This platform incorporates features like real-time monitoring, tracking of participant inclusions, and comprehensive project management. Quanta View is designed to support you in every facet of your clinical research journey. It is easily accessible online and features a responsive design that adjusts seamlessly to various devices, including tablets and laptops. Tailored specifically for the pharmaceutical, medical device, and cosmetic sectors, Quanta View ensures that all research needs are met with precision and adaptability. It is an essential tool for researchers aiming to optimize their workflows and enhance data integrity.

At Calyx, we recognize that the success of any clinical development project hinges on the integrity of your data, highlighting the crucial role of an effective electronic data collection (EDC) system. Utilized in more than 2,600 clinical trials around the world, Calyx EDC streamlines the collection and reporting of clinical trial data through a platform that is both intuitive and efficient. It is vital to protect your essential data with a dependable partner—contact us to learn how Calyx can bolster the success of your initiative. With Calyx EDC, you acquire the flexibility to seamlessly plan, design, and manage studies, regardless of their complexity. Its comprehensive features are designed to reduce costs, improve site visibility, and enhance overall efficiency, ensuring your trial stays on track. Count on Calyx to be the support you need to navigate the intricate landscape of clinical trials, enabling you to focus on what truly matters. Your journey toward successful clinical outcomes begins with the right partnership.

If you're involved in clinical research, you probably recognize that collecting data can be a considerable time sink and may lead to disorganization, especially when using paper forms. This challenge is what inspired the creation of Teamscope: a solution designed to simplify the data collection process while ensuring its security and enabling immediate analysis. Our objective is to ease your worries about managing research data, allowing you to concentrate on the areas of your work that you find most fulfilling. Moving from traditional paper-based methods to an electronic system like Teamscope is both fast and easy. With our online form builder, you can customize your survey forms using a variety of 11 field types. Furthermore, the skip logic feature allows you to manage which fields are displayed based on users' answers, making it simpler to create dynamic survey paths. Through the use of skip logic, you can craft complex pathways that cater specifically to your research requirements, and our team of experts is ready to help you develop even the most elaborate forms on Teamscope. In conclusion, this cutting-edge tool not only improves your experience in collecting data but also enhances the effectiveness of your research efforts, ultimately contributing to better outcomes in your studies. By adopting Teamscope, you are taking a significant step towards modernizing your data collection practices.

EvidentIQ's eCOA simplifies the process of gathering real-time data directly from patients via an intuitive interface, which not only improves patient evaluations but also elevates the quality of data collected. Clients can opt for a comprehensive eCOA package or customize their selection by combining different components to meet specific requirements. By arranging a demonstration with our expert team, you can learn how to optimize the return on investment for your research initiatives. The eCOA platform integrates data science services with advanced technology, offering a flexible solution. It functions independently of specific eClinical technologies such as EDC systems, while also providing smooth integration with current eClinical software environments. This system is designed to efficiently collect a diverse array of outcome data from patients, healthcare professionals, or observers, ensuring compliance and improving the data collection experience overall. With its adaptable nature, organizations can tailor the eCOA framework for various clinical trial situations, thereby significantly enhancing their research capabilities and outcomes. Such customization not only meets immediate needs but also prepares teams for future challenges in clinical research.

In comparison to other Electronic Data Capture (EDC) systems offered by firms like MediData, DataTrack, and Omnicomm, TrialStat emerges as the most all-encompassing suite of tools for study management, providing seamless integration with a variety of external data sources such as electronic medical records (EMR), wearable technology, and both clinical and non-clinical information systems. TrialStat offers a unified platform that supports every stage and type of clinical trial. Our EDC suite is equipped with a single sign-on feature and accommodates multiple tenants, featuring modules for Randomization, Adjudication, Coding, Safety, Patient Diaries/ePRO, a Vendor Neutral Imaging Archive, a comprehensive Reporting and Analytics Portal, and customized Machine Learning solutions. With a strong focus on data analysis, TrialStat ensures real-time reporting, on-demand data extracts, and analytics that encompass a single study, a program, or the full breadth of your research portfolio, providing all stakeholders with relevant, tailored, and timely insights into all aspects of study data while identifying potential risks or delays. Furthermore, the platform’s robust integration capabilities enhance collaboration among research teams, resulting in a more streamlined and productive trial management process. This ultimately empowers researchers to make informed decisions that drive the success of their clinical trials.

Jeeva has developed a revolutionary modular system that operates on a cutting-edge cloud platform. With just one login from any device that supports a browser, users can easily screen patients, offer education, manage enrollment, send SMS and emails, and compile evidence such as electronic patient-reported outcomes. Frustrations with slow patient recruitment and retention are common in the industry, making it imperative to gather solid evidence of safety and efficacy for new investigational medicines to secure approval from regulatory agencies. Jeeva stands out as an invaluable resource for optimizing time and financial resources for patients and biopharma sponsors, particularly in long-term follow-up studies associated with gene therapy. Its innovative approach streamlines processes, ultimately enhancing the efficiency of clinical trials and improving patient care.

Zelta serves as a cloud-based platform dedicated to the unified management and acquisition of clinical data, aiming to optimize and improve the processes involved in clinical trials. Its flexible modular structure is tailored to meet the specific requirements of different studies, which leads to quicker and more effective results. With features that include electronic data capture, management of clinical operations—such as randomization and tracking of trial supplies—clinical trial oversight, and electronic trial master file capabilities, Zelta provides thorough supervision of studies. Additionally, it fosters engagement among patients and providers through electronic clinical outcome assessments and e-consent options. Suitable for a range of studies across all phases, therapeutic disciplines, and international locations, Zelta is designed to offer a user-friendly experience with secure single sign-on access available from any location. Its adaptable and scalable framework permits easy customization and seamless integration with both proprietary and third-party technologies, ensuring it can meet various research requirements effectively. This makes Zelta an invaluable tool for researchers looking to streamline their clinical trial efforts.

Replior stands out as an innovative company that focuses on delivering advanced software solutions tailored for clinical trials, featuring a comprehensive platform that integrates EDC, eConsent, ePRO, and Virtual Visits to optimize trial execution. Our all-encompassing system, known as Trial Online, streamlines the collection and management of data from researchers, participants, and wearable technology efficiently. It is meticulously designed to support decentralized clinical trials (DCT), providing the flexibility to accommodate site visits, remote interactions, or a blend of both. Our journey began two decades ago when we were tasked with developing an online CRF service for a prominent pharmaceutical company, which marked our evolution from an IT operations provider into a specialized software developer focused on clinical data collection. Over time, we have broadened our offerings to provide a full range of data collection services, while our IT operations are adeptly overseen by our highly skilled sister company, Complior. As we forge ahead, our unwavering commitment to innovating and improving clinical trial processes remains central to our purpose, driving us to continually enhance user experience and data integrity in the trials we support.

Data MATRIX provides an all-encompassing SaaS platform tailored specifically for clinical trial management. Established in 2009, the Data MATRIX team has focused on the intricate processing and analysis of clinical data, producing documentation that adheres to the regulations set forth by the Russian Ministry of Health, FDA, and EMA. Our innovative software simplifies the clinical trial workflow, enabling users to effectively oversee and monitor their progress through an online interface. Prior to the initiation of any project, we ensure to thoroughly adjust and validate our software, taking into account every detail necessary for peak performance. With a successful history of completing 180 projects for various pharmaceutical companies, biotech enterprises, and contract research organizations, our solutions have contributed to 6 of the top 10 Big Pharma firms achieving a notable 15% decrease in research and development costs. The commitment of our dedicated team extends beyond projects as they are actively engaged with professional networks that link clinical data professionals such as CDISC, ACDM, SCDM, biostatisticians like ISBC, and medical writers affiliated with EMWA and AMWA. By consistently refining and advancing our offerings, we strive to foster innovation within the clinical research sector, ensuring that our solutions remain at the forefront of industry needs. This commitment to progress not only supports our clients but also enhances the overall landscape of clinical trials globally.

Axiom has developed Fusion, a unique and affordable eClinical platform designed specifically for small to medium-sized companies in the device, pharmaceutical, and biotech sectors. This comprehensive eClinical Suite offers customizable Modules tailored to your study’s specific requirements. If you are conducting a smaller study, you can select a foundational setup that includes Electronic Data Capture (EDC) and Data Management (DM), along with Adverse Event (AE) and Serious Adverse Event (SAE) tracking. For those seeking enhanced functionalities, Fusion provides advanced Modules such as Inventory Tracking, Randomization and Trial Supply Management (RTSM), and Safety Management to streamline study oversight. The platform also facilitates the electronic collection of study data, even in offline scenarios, ensuring that once an internet connection is available, your information seamlessly syncs with the Fusion databases. This capability enables real-time access to records relevant to subject screening activities, while the Fusion Safety Database effectively supports the management of pharmacovigilance events for improved patient safety. Overall, Fusion stands out as a versatile solution to meet diverse clinical trial needs.

DFnet is a healthcare technology firm that focuses on providing eClinical solutions, including electronic data capture, eSource, and extensive data management services. We enhance clinical trials on a global scale by offering greater flexibility, superior data quality, and increased efficiency. Our platform facilitates data collection from diverse sources, such as paper CRFs, EDC, and other electronic systems, as well as through online and offline tablet entries and ePRO. Users have the option to implement our system on-site or take advantage of our secure cloud hosting services. Our cutting-edge optical recognition technology accelerates both SDV and RBM processes, greatly minimizing the time necessary for manual data entry. Tailored for maximum versatility in multi-center studies, our web-based data capture system ensures that information from any source is easily accessible in a centralized real-time platform. This feature empowers researchers to make swift and informed decisions, ultimately enhancing the overall execution of clinical trials and leading to better outcomes. Additionally, our commitment to innovation means we are constantly evolving our solutions to meet the changing needs of the healthcare landscape.

Mahalo Health is a comprehensive digital health platform designed to accelerate the development of patient-centered digital health solutions and clinical trials. It offers an array of prebuilt modules that enable the rapid deployment of customizable white-label applications tailored to specific therapeutic areas. The platform is equipped with advanced data capabilities, which include a predictive health engine for anticipating diseases and diagnoses, a behavior modification engine that promotes healthy patient habits, and a notification system that guarantees prompt communication via push notifications, SMS, or emails. Mahalo Health is dedicated to upholding rigorous security and compliance standards, adhering to regulations like HIPAA, GCP, ISO27001, and GDPR. Its diverse service offerings span various therapeutic domains, such as diabetes management, cognitive health, cardiovascular care, musculoskeletal issues, mental well-being, oncology, rare diseases, and nonalcoholic steatohepatitis (NASH). Furthermore, Mahalo Health not only enhances patient engagement but also improves health outcomes by equipping healthcare providers with innovative digital tools and solutions that adapt to the evolving needs of their patients. This commitment to innovation ensures that healthcare delivery is both efficient and personalized.

The analysis of medical imagery powered by artificial intelligence is enhanced through advanced automation of clinical data workflows. Available as either a web-based SaaS or an on-premise solution, UNITY has gained international credibility from top medical technology companies and healthcare organizations for its proficiency in collecting thorough, reliable, and compliant data. Its integrated features for Patient-Reported Outcome Measures (PROM), electronic Case Report Forms (eCRF), and medical image analysis streamline critical data gathering activities, which in turn accelerates and reduces the costs of clinical trials. RAYLYTIC's Imaging Core Lab brings years of expertise to the automated and independent evaluation of musculoskeletal structures and device performance, particularly in the spine, hip, and knee, offering clients exceptional analytical and operational support. This state-of-the-art capability guarantees that healthcare professionals can depend on high-quality data for their decision-making, ultimately enhancing patient outcomes and fostering greater trust in medical processes. By implementing these innovative solutions, healthcare systems can greatly improve efficiency and accuracy in clinical trials.

Our cutting-edge Smart Protocol system is engineered to integrate automation and advanced intelligence into the architecture of clinical trials through the use of artificial intelligence. This revolutionary system is reshaping the outdated manual methods that research teams have depended upon for designing clinical trials. In the current digital era, it has become nearly impossible for individuals to meticulously examine every aspect necessary for making informed decisions. Additionally, a multitude of organizations hold precious data that often remains underutilized, with documents stored in systems that lack adequate access. As a result, life science companies may end up making substantial and costly decisions based on inadequate information. Our mission is to shift organizations like yours from a focus on document-centric practices to a more insightful, data-driven framework. We are transforming the research and planning processes for clinical trials by removing barriers that keep data from reaching its intended users. To achieve this, we collect vast amounts of trial-related documents from both your internal assets and the public realm, allowing you to concentrate on what truly matters—enhancing patient outcomes. By streamlining access to essential data, we empower teams to make quicker and more effective informed decisions, ultimately leading to more successful trial results in the future. This holistic approach not only improves efficiency but also fosters innovation in clinical research.

Flex Databases offers a cutting-edge, integrated, and compliant electronic clinical platform that delivers software solutions tailored for clinical trials, serving pharmaceutical companies and contract research organizations (CROs). Our comprehensive system includes a Clinical Trial Management System, an Electronic Trial Master File, a project management and budgeting tool specifically crafted for the clinical trials sector, a Pharmacovigilance System, and a Learning Management System. This adaptable platform was developed through the expertise of a skilled team of over 100 professionals who possess extensive knowledge of the complexities involved in the clinical trial process. Additionally, our commitment to innovation ensures that we continually evolve our offerings to meet the changing needs of the industry.

Science 37 is an innovative clinical research organization that specializes in decentralized clinical trials using its unique Metasite model, which removes the necessity for physical locations, enabling patients to participate in studies from nearly any location. This approach significantly increases accessibility, allowing over 90% of individuals who may typically be excluded from traditional site-based research to take part, and it boasts recruitment capabilities similar to those of 20 sites concentrated in one area, providing patients with the flexibility they seek. The Metasite leverages a proprietary platform that simplifies study management and enhances workflow for both patients and research personnel, all while ensuring efficient data capture without the need for manual reentry. By consolidating staff, processes, and technology, this model ensures built-in compliance with protocols, leading to improved adherence rates and the collection of high-quality data. Furthermore, Science 37's committed in-house medical professionals, telemedicine investigators, and mobile nursing teams possess extensive experience in managing remote trials across a wide variety of therapeutic areas, guaranteeing extensive outreach and support. This dedication to pioneering trial methodologies establishes Science 37 as a leader in reshaping the clinical research landscape, thereby opening new avenues for patient engagement and participation.

Introducing Dotter.science, the ultimate online platform dedicated to advancing clinical research. Specifically crafted for researchers and organizations involved in health research protocols, Dotter allows you to focus on the essential aspects of your study while executing it efficiently. The platform facilitates the seamless collection and analysis of clinical research data, making the entire experience more streamlined. With Dotter.science, you can swiftly design personalized data collection forms, enhancing the effectiveness of your clinical research databases and simplifying both your statistical analysis and publication processes. Aimed at researchers, healthcare practitioners, and students alike, Dotter is designed to significantly boost time management and operational productivity. Among its features are optimized data collection capabilities through a user-friendly graphical interface for creating electronic logbooks (eCRF), which enables quick patient enrollment complemented by real-time data consistency checks. Additionally, with Dotter’s efficient statistical analysis, you can leave traditional paper records behind! Your data will be securely stored on certified servers throughout the duration of your study, and you can conveniently export it in structured formats, guaranteeing that your research remains safe and easily accessible. This innovative platform stands as more than just a tool; it is a comprehensive solution tailored to meet the multifaceted demands of contemporary clinical research, ensuring you are well-equipped for success in your endeavors.

Flask Data empowers teams involved in life science research and development by providing them with timely clinical data and effective solutions aimed at ensuring patient safety. The Flaskdata.io cloud API platform simplifies the data collection processes for a variety of stakeholders, including patients, researchers, site coordinators, connected devices, and pharmaceutical companies. Our services in data management and safety oversight are crafted to reduce risks associated with the integrity of clinical data, the safety of patients, and adherence to established protocols. The Flaskdata.io platform is designed to be both automated and scalable, ensuring it can adapt to the unique needs of your clinical trials. As a technology company specializing in clinical data oversight and management, Flask Data stands out for its commitment to providing optimal solutions that guarantee high-quality clinical data while placing a strong emphasis on patient safety. Understanding that each clinical trial presents its own set of challenges, we focus on comprehensively grasping the specific issues you face. By fostering a collaborative relationship with your team, we aim to develop customized solutions that not only fulfill your requirements for high-quality clinical data but also enhance patient safety, thereby contributing significantly to the success of your research projects. Ultimately, our dedication to innovation and collaboration ensures that we remain a valuable partner in your clinical endeavors.

g.BSanalyze is an interactive platform that facilitates the processing and analysis of multimodal biosignal data, specifically targeted at clinical research and life sciences. With over 20 years in the market, it has established a presence in more than 70 countries around the globe. This software is recognized as the most comprehensive toolkit available for assessing both non-invasive and invasive functions and dysfunctions related to the brain, heart, and muscles. Its outstanding performance has earned it numerous international accolades. The newest version introduces a wide array of features, including topographic plots, Canonical Correlation Analysis (CCA), advanced filtering capabilities, a cortiQ file importer, improvements for Result2D, and specialized tools for analyzing Cortico-Cortical Evoked Potentials, as well as dedicated toolboxes for electrocorticography (ECoG) and transcranial magnetic stimulation (TMS). The software is also equipped with various sample biosignal datasets encompassing 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. Additionally, it features a highly interactive and user-friendly graphical interface that supports the analysis and documentation of EEG, ECoG, EOG, EMG, ECG, spike data, and diverse physical datasets within the MATLAB environment. In summary, g.BSanalyze emerges as a robust solution for researchers and practitioners eager to explore the intricate realms of biosignal analysis, making it an invaluable asset in the field. Furthermore, its continuous updates ensure that users have access to the latest advancements in biosignal research.

CORE (Clinical On-demand Research) offers an extensive range of specialized services that include the design, development, and management of electronic forms used in clinical trials across the UK and globally. Beyond creating the essential forms, CORE also manages randomization processes, data oversight, and provides vital study statistics, ensuring that researchers have the key information they need. This organization plays a critical role in gathering significant data for both academic and commercial research sectors. Notably, CORE has formed a successful partnership with FormsVision, which originated from an FP7 EU funding initiative, and has integrated the ALEA eCRF (electronic Case Report Form) to improve trial execution in the UK and New Zealand. The dedicated team at CORE is prepared to deliver a wide range of services, which encompass database development for CRFs, management of randomizations, coordination of drug supplies, and ePRO (ALEA) solutions. They also provide data hosting services for various file types and offer expert assistance with funding applications, statistical analysis, and protocol development. By delivering this comprehensive array of services, CORE solidifies its role as an essential collaborator in the progression of clinical research initiatives. Their commitment to enhancing research methodology and data integrity further underscores the importance of their contributions to the field.

Effective management of clinical data is essential for the success of clinical trials. A thorough solution for handling trial information facilitates seamless data entry and the creation of Case Report Forms (CRFs). It accommodates complex, multi-center studies while significantly speeding up data validation and processing. The system also boasts multilingual support, allowing for global deployment in both cloud-based and on-premise environments. Clinical researchers are acutely aware of the need to minimize costs and time during trials, particularly regarding the collection and management of specific study data. In the past, study coordinators relied on paper CRFs to ensure that critical patient information was recorded and conveyed to sponsors for analysis. However, those times are now a thing of the past. The industry has shifted towards electronic data capture (EDC) systems, which enhance efficiency and elevate the quality of the collected data. By adopting these modern systems, researchers can focus more on their core activities while ensuring accurate data management.

Longboat is a cloud-based platform tailored to enhance the efficiency of clinical trials, featuring an integrated Guided Compliance toolset that provides ongoing assistance to users throughout the entire process. By equipping clinical trial site personnel with vital resources, Longboat allows them to focus more on patient care. Moreover, participants can conveniently access important study information and receive timely reminders for upcoming visits. The system streamlines the management of protocol amendments, ensuring they are implemented smoothly and effectively. Additionally, Longboat centralizes the secure exchange of regulated documents among sponsors, CROs, and sites, thereby significantly improving the startup process and alleviating the burden of traditionally tedious tasks for all involved in research. With a unified support platform, all primary stakeholders—including clinical operations teams, monitors, site staff, and trial participants—can access tailored content that meets their specific needs. This holistic strategy guarantees that site staff are well-equipped with the necessary tools and resources to stay engaged and compliant while maintaining a strong focus on participant welfare. In this manner, Longboat not only enhances operational efficiency but also significantly enriches the overall experience for everyone participating in the clinical trial, fostering a more collaborative and effective research environment. By prioritizing user needs, Longboat paves the way for innovative solutions in clinical research management.

Prism is a versatile statistical software developed specifically for scientists, as opposed to statisticians. You can begin your analysis by entering data into specially designed tables for scientific research, which will guide you in choosing statistical techniques that improve your research productivity without requiring any programming skills. Throughout this journey, you will receive valuable insights and support, enabling you to make well-informed choices regarding your analyses, understand the critical assumptions at play, and accurately interpret your results. Moreover, Prism simplifies collaboration with colleagues, making it easy to obtain feedback from peers and disseminate your research findings to a broader audience with minimal effort. The transition from raw data to polished, publication-ready graphs is seamless and straightforward. Prism also offers a plethora of customization options for your visual outputs, including different color schemes and methods for organizing data. You have the flexibility to export your work in various formats, share it directly to PowerPoint, or even email it straight from the application. In addition, you can bolster your expertise in data analysis and visualization through exclusive educational materials designed by experienced professionals in the field, ensuring you are equipped to tackle any research challenge effectively. With its intuitive interface and comprehensive features, Prism not only streamlines the research process but also empowers users to meet and exceed their research objectives. This combination of functionality and user support makes Prism an invaluable tool for scientists at every level.

Datatrak International, Inc. specializes in providing software-as-a-service solutions that utilize cloud-based technology tailored for the life sciences sector. Their integrated eClinical solution, along with associated services, enhances both the efficiency and cost-effectiveness of clinical trials. The company has crafted a robust, multi-faceted solution that operates on a unified platform, which was further enhanced by the inclusion of service delivery through their Clinical and Consulting Services teams. With a comprehensive suite of software products, Datatrak accelerates the reporting process of clinical research data to both sponsors and regulatory bodies, outpacing the capabilities of disjointed technologies. The aim is to equip teams with features such as role-specific access, version-controlled document management, as well as integrated calendar functionalities, tasks, and contact management. All of these components are seamlessly integrated within their eClinical software offerings, which encompass EDC, CTMS, and various reporting tools. By consolidating these functionalities, Datatrak significantly streamlines the clinical trial process.

OpenText™ Information Management solutions provide life sciences organizations with the tools needed to leverage data and content insights, improving their decision-making processes and accelerating product development timelines. These solutions facilitate the smooth integration, management, and secure exchange of information across individuals, systems, and devices. By optimizing the use of information assets from research and development to commercialization, companies can take advantage of flexible cloud-native software that functions seamlessly in various environments. OpenText specifically tailored for the life sciences sector greatly speeds up the discovery phase, enabling the extraction of actionable insights that drive innovation throughout the development pipeline. Users can transform research articles into electronic lab notebooks via intelligent capture and harness text mining techniques to reveal valuable insights. Furthermore, the platform excels in extracting knowledge from unstructured text found in clinical trial reports, study protocols, and data pertaining to clinical safety and efficiency. It also provides tools for the intelligent analysis, categorization, and extraction of information from clinical trial documents, thereby reducing the likelihood of costly delays and disruptions in the development process. By harnessing these advanced features, life sciences organizations can significantly improve their operational efficiency and propel their research initiatives forward while remaining competitive in a fast-evolving field. The integration of these tools ultimately enhances collaboration and innovation across the entire organization.

uMotif presents a groundbreaking platform for electronic Clinical Outcome Assessment (eCOA), electronic Patient-Reported Outcomes (ePRO), and electronic consent (eConsent), designed to bolster both clinical and real-world research initiatives. Developed with direct feedback from patients, this platform ensures exceptional engagement, leading to significant enhancements in the efficiency, quality, and accuracy of data gathering. By merging uMotif's eCOA/ePRO system with real-time glucose monitoring, the platform demonstrated impressive compliance rates during an extensive diabetes research project throughout Europe. In a separate case, an immunology trial reaped the benefits of the patient-centric eCOA/ePRO solution, allowing the sponsor to meet data collection targets a remarkable six months earlier than planned. Furthermore, during a CNS study required by the FDA, participants leveraged their own devices to submit ePRO data that was ready for review, illustrating the platform's adaptability. Committed to a patient-first design philosophy, uMotif places a strong emphasis on comprehending the patient experience and the variables that affect their actions. This deep-rooted understanding not only drives the creation of software tailored to patient needs but also achieves exceptionally high levels of engagement for study sponsors, creating a mutually beneficial scenario for all involved. With such innovative features, uMotif is poised to set new standards in the realm of patient-reported outcomes and clinical research methodologies.

Discover the leading edge of eSource, CTMS, and eRegulatory software tailored for clinical trial sites with CRIO. Our premier electronic source enables you to capture source data in real-time, significantly reducing paper dependency by up to 90% and improving data quality by 80%. Take control of your operations with CRIO’s intuitive Clinical Trial Management System, which streamlines patient scheduling, financial oversight, and recruitment optimization. We proudly offer innovative electronic regulatory binders, featuring the groundbreaking first-ever electronic delegation log, all fully compliant with 21 CFR Part 11 regulations. For sponsors of clinical trials, our secure online portal allows for complete remote monitoring of your sites’ source data and regulatory documents. Join our vast network of over 500 clinical research sites globally, and benefit from our dedication to enhancing your business by simplifying your site operations. This ensures that your studies progress seamlessly, whether you are on-site or working remotely, allowing you to concentrate on what truly matters: propelling your clinical research efforts forward while ensuring efficiency and accuracy throughout the process.

A reliable and intuitive cloud-based Electronic Data Capture (EDC) platform designed to oversee clinical trials and studies, regardless of their scale or complexity, encompassing features like electronic patient-reported outcomes (ePRO), electronic consent (eConsent), electronic clinical outcome assessments (eCOA), electronic source data (eSource), patient-reported outcome measures (PROMs), patient-reported experience measures (PREMs), functional health assessments, and tools for participant education and engagement. This versatile platform enhances the efficiency of research processes, ensuring that both researchers and participants have a seamless experience throughout the study.

Enhance the efficiency of your clinical studies with Clinvigilant, your global provider of budget-friendly eClinical tools tailored for CROs, Pharma, Biotech, Nutraceuticals, and academic institutions throughout both clinical and post-marketing phases. Our clients consistently choose to partner with us due to our: ♦ Rapid EDC implementation (under 4 weeks). ♦ Cost-effective solutions. ♦ Integration capabilities with third-party and legacy systems. Our cloud-based platform, hosted on Microsoft Azure, adheres to HIPAA, ICH-GCP, GDPR, and 21 CFR part 11 regulations and has successfully undergone audits by the FDA, EMA, and MHRA. The Clinvigilant eClinical suite encompasses a variety of tools, including EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent, and eCOA. You can select the specific tools you require, and we will seamlessly integrate them into your existing software framework. Each interaction and data exchange generates detailed Audit Trails, ensuring real-time visibility of compliant data across all relevant roles. Our offerings are modular, highly customizable, and accessible via web, iPad, and mobile applications for both Android and iOS platforms. Additionally, we support the use of Patient's Own Devices (BYOD) and can interface with various devices and wearables for enhanced data collection. With Clinvigilant, you can count on a comprehensive solutions provider to streamline your clinical trial processes effectively and efficiently. Your success in clinical research begins here.

Our platform provides a web-based interface specifically crafted for the efficient gathering of data across diverse studies and clinical environments. With its customizable and user-friendly data entry options, it can be adapted to fit any medical specialty, patient group, or research project. The system significantly improves care quality by tracking patient-reported outcomes and utilizing population analytics to inform decisions. Its secure, web-based format guarantees compatibility with both laptops and tablets, ensuring smooth data input regardless of the device used. Researchers enjoy the advantage of real-time reporting features, which allow them to manage the entire study process for both single-site and multi-site trials, regardless of their location. The DADOS Platform boasts a remarkable user interface (UI) and intuitive tools that enable clinicians and researchers to create programs or studies that effectively bridge the gap between research and clinical application. Patients are drawn to DADOS for its ease of use and the ability to access it from virtually anywhere, making it an essential tool in contemporary healthcare settings. Ultimately, this forward-thinking platform nurtures a collaborative atmosphere where research initiatives and patient care can flourish in unison, enhancing the overall quality of healthcare delivery.

Explore the latest advancements in collecting clinical and patient-reported outcomes data. Our all-encompassing solution goes beyond simple data recording, aiming to create a truly patient-centered research journey. Our eCOA software, built on the foundations of behavioral science, has been meticulously crafted by healthcare experts to cater to the demands of both research sites and sponsors. By focusing on individual identity, motivational triggers, and key goals, we differentiate ourselves from other eCOA platforms. The Datacubed app is designed with an intuitive interface, enabling participants to easily engage with essential elements. It has been noted that the process of data collection is now more efficient than ever, thanks to our flexible, user-friendly, and interactive application. As the necessity for adaptable trial designs becomes increasingly prominent, we offer a range of versatile data collection methods that can be conducted in-person, remotely, or through a hybrid model, accommodating the varied needs of conventional, hybrid, and virtual clinical studies. This level of flexibility guarantees that researchers can capture the most pertinent data, irrespective of the format of the trial. Furthermore, our commitment to continuous improvement ensures that we remain at the forefront of innovation in the field.

Entrypoint is a comprehensive platform designed for the development, deployment, and management of customized data entry applications, allowing users to access data entry and system administration capabilities from virtually anywhere. This collection of user-friendly tools enables individuals to create, execute, and manage a wide variety of bespoke data entry applications, featuring built-in validation, editing functionalities, and various export options. With a plethora of integrated features, Entrypoint facilitates the incorporation of sophisticated elements such as range checks and table lookups, enhancing the overall user experience. The conventional practice of collecting information through paper forms followed by manually inputting it into a digital system is not only labor-intensive but also susceptible to errors in transcription. By adopting electronic forms for direct data entry into a database, organizations can effectively eliminate the cumbersome intermediary paper process and its associated pitfalls. Additionally, the shift to electronic data capture proves increasingly beneficial for organizations confronting higher data volumes and rising costs, as it promotes streamlined processes and improved efficiency in data management. Therefore, Entrypoint emerges as a vital resource for organizations aiming to upgrade and modernize their data processing methodologies, positioning them for greater success in a digital landscape.

LifeSphere EDC provides a cost-effective option for sponsors and CROs to efficiently collect, manage, and report data from clinical trials, no matter the complexity or phase of the trial. By unifying multiple systems into a single database, it removes the need for costly integrations and the cumbersome data reconciliation process. The platform gathers clinical data straight from study sites, eliminating the dependency on traditional paper Case Report Forms (CRFs) and manual data entry. This streamlined process not only accelerates study development timelines but also allows for seamless modifications during ongoing trials. When integrated with the LifeSphere Clinical cloud platform, which comprises both LifeSphere eTMF and LifeSphere EDC, it successfully connects operational tasks with data management. Moreover, the single sign-on feature enhances user access to a wide range of applications, while its open architecture fosters rapid integration with external systems via APIs. This remarkable efficiency ensures that clinical research remains responsive to evolving needs and upholds stringent data quality standards. As a result, sponsors and CROs can navigate the complexities of clinical trials with greater confidence and agility.

Jumpstart your project by choosing one of our applications as a foundation for your customization and configuration needs. Should you not discover a suitable option, you have the opportunity to create a new application entirely from scratch with the help of our intuitive visual designer. This designer comes equipped with a range of powerful pre-built components, giving you the freedom to construct forms, set up workflows, and craft your application via a simple drag-and-drop interface, all without writing any code! Make use of the user-friendly visual designer to design your study, tailoring your database to meet your specific research and data collection requirements. You can effortlessly gather and analyze your data through customizable screens, which allows you to spot inconsistencies, handle incomplete submissions, and monitor follow-ups with ease. Organize your database into easily manageable segments based on your chosen criteria, and create filters using natural language for improved accessibility. Furthermore, take advantage of saved datasets for thorough reporting, workflow management, patient tracking, and extensive data analysis, ultimately optimizing your project’s procedures and enhancing overall productivity. With these tools at your disposal, you can ensure that your project runs smoothly and effectively.

As a specialist in Data Management, we provide a wide array of services that encompass not only data management but also the strategic planning and development of statistical analyses along with appropriate CRF design. We take care to ensure that all required documentation adheres to FDA regulations and other pertinent guidelines. Our past experiences have shown that dedicating additional time to the planning phase can significantly improve the efficiency and speed of the trial's concluding stages. Our databases are crafted with precision by experienced data managers who have a deep understanding of various eCRFs and the crucial elements involved in designing electronic data capture systems and collecting data. This level of expertise allows us to develop the eCRF in an impressively short period. Furthermore, the validation and testing of the eCRF are vital components of our design process, performed by specialized personnel to ensure a comprehensive and functional eCRF. By emphasizing these critical aspects, we guarantee exceptional quality outcomes for our clients, fostering a collaborative relationship built on trust and results. Ultimately, our commitment to excellence positions us as a leader in the field of data management services.