Alternatives to eAdjudication

Through the use of the eAdjudication® software managed service, trial leaders can effectively oversee timelines, adapt to fluctuating circumstances and results, and track trends in provider performance and adherence to protocols throughout the extended duration of trials. This innovative, comprehensive managed software service helps prevent unforeseen expenses and timeline violations in Endpoint Adjudication Studies. The eAdjudication® Managed Software Service stands out as the most effective solution for managing Endpoint Adjudication (CEC). By collaborating with the eAdjudication® platform and Ethical's staff, study teams, committee members, and clinical organizations can engage seamlessly in real-time within a user-friendly and GxP-compliant framework, eliminating the inefficiencies, costs, and errors associated with manual processes. Furthermore, the all-inclusive nature of eAdjudication® services facilitates the smooth integration and adoption of EA software across eClinical organizations, enhancing overall operational efficiency. In doing so, it empowers research teams to focus on delivering quality results without being hindered by logistical challenges.

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.

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.

eDeviation provides comprehensive tools for assessing and managing Protocol Deviations. It streamlines processes from software design and validation to gathering necessary documentation and exporting information for the Trial Master File (TMF), thereby alleviating the burden on clinical teams who may face risks from improperly assessed or overlooked protocol deviations, whether they occur once or multiple times. As a component of Ethical's eClinical Software Platforms, eDeviation® enhances the efficiency and accuracy of clinical trial management. Whether evaluations are conducted by a dedicated independent committee or by your own research team, our software can be tailored to meet your specific requirements. The integration of forms, workflows, and export functions ensures adherence to GxP standards and fosters effective study management. Additionally, this platform allows study teams, investigators’ sites, and committee members to collaborate online in real-time, facilitating quicker decision-making, reaching consensus, and ensuring the prompt handling of protocol deviation assessments and management. Ultimately, eDeviation® enhances the overall integrity and efficiency of clinical trial processes, contributing to better outcomes in research.

Clinical One RTSM is capable of accommodating various randomization strategies, ranging from the most straightforward to highly intricate studies, all without requiring any programming or coding, which consequently reduces the duration of user acceptance testing. You can take charge of your study with self-service configurations, allowing you to develop a study in just a matter of days rather than weeks. Additionally, you can assess the drug inventory status and make real-time adjustments without needing to consult the vendor, thereby avoiding unnecessary costs and change requests. By implementing changes swiftly, you can eliminate expenses associated with change requests and prevent delays, enabling you to launch your studies almost instantaneously. This platform stands out as the only one that genuinely integrates individuals, processes, and data to streamline and expedite the future of clinical trials. Moreover, the inclusion of virtual components in clinical trials enhances patient engagement and significantly elevates the quality of trial data. To keep pace with the rapidly evolving landscape, it is essential to adopt transformative digital strategies that facilitate quicker study initiations, harmonize data from diverse sources, and optimize workflow efficiency. Such advancements are pivotal for the successful execution of modern clinical research initiatives.

Modern Interactive Response Technology (IRT) systems are becoming more intricate. The significance of flexible and customizable IRT cannot be overstated, as this technology serves as the primary source for essential data, including recruitment metrics, clinical trial attrition rates, patient attendance, and more. It is vital to select a platform that is intuitive, optimized for mobile use, and all-encompassing—underpinned by high standards of quality, adaptability, and expertise. Embrace a partnership that offers profound therapeutic knowledge tailored to the contemporary risk-based eClinical landscape. By merging advanced technology with specialized knowledge and a dedication to exceptional service, we enhance clinical trials to achieve favorable patient results. Our extensive understanding of clinical processes and supply chain dynamics fosters innovation, granting clients greater control over their Randomization and Trial Supply Management (RTSM) protocols. Our cutting-edge tools elevate quality assurance, improve site productivity, and enhance patient adherence significantly. Furthermore, our IRT platform is adaptable enough to cater to a wide array of studies, with the capability for full validation and deployment in just 30 days, ensuring efficiency in clinical trial operations. This swift implementation can lead to more timely data collection and improved overall trial management.

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.

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.

AssisTek stands out as a frontrunner in cutting-edge clinical technology solutions tailored for clinical research, providing specialized software that optimizes and improves the process of gathering patient data. With a legacy of over 25 years, the company has successfully facilitated more than 800 clinical research trials spanning 46 therapeutic areas, which include upwards of 500 multinational Phase I–IV clinical trials. Their electronic Clinical Outcome Assessment (eCOA) solutions boast scalability, customization, and efficiency, backed by a reliable cloud-based technology platform. Among their extensive product offerings are the TEK eCOA Tablet, which accommodates any questionnaire utilized in clinical trials, TEK eDiary, enabling the collection of patient-reported outcomes from home, TEK Configurator for comprehensive project development in clinical trials, and TEK Study Portal, which consolidates eClinical tracking, training, and reporting into one convenient location. AssisTek's innovative systems and services have established them as the preferred partner for data collection and analytics, winning the trust of both patients and healthcare professionals alike. As they continue to evolve, AssisTek remains committed to enhancing the efficiency and accuracy of clinical research methodologies.

Our versatile electronic Case Report Form (eCRF) platform is designed specifically for non-commercial clinical trials and can be tailored to fit any study protocol with ease. Developed through extensive collaboration with researchers and medical professionals over many years, our eCRF solution prioritizes usability, offering a straightforward and flexible interface. Additionally, the system complies with all necessary quality standards, and since we maintain complete control over the codebase, we have the capability to continually enhance and modify it in response to evolving regulatory demands and the dynamic landscape of clinical trials. This ensures that our platform remains not only relevant but also ahead of the curve in meeting the needs of researchers and participants alike.

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.

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☁️ .

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.

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.

The Datimbi Platform is exceptionally designed for scenarios that require the gathering of extensive and intricately structured data from various contributors or sources, featuring integrated quality assurance measures and the ability to oversee and manage quality and collection processes in real time, along with comprehensive reporting and analysis capabilities. Furthermore, rapid setup is a key feature of our platform. It is tailored for applications like electronic Case Report Forms (eCRFs) in Clinical Trial Management, Social Case Management, econometric event study evaluations, or virtually any data collection and processing workflow that demands efficiency. If your requirements align with these use cases, you can often achieve full deployment and operational status on the platform within just one week! Setting up roles, transitioning workflow statuses, designing complex data collection forms, defining processing rules, managing lists of values, tracking changes, and creating custom email notifications can all be accomplished through an intuitive web interface. Additionally, these functionalities can be administered by your own trained personnel or through a service provided by Datimbi, ensuring flexibility and support for your organization's needs. This combination of speed and ease of use makes the Datimbi Platform a valuable asset for any data-intensive project.

Suvoda is a worldwide leader in clinical trial technology, focusing on intricate, life-preserving studies in fields like oncology, central nervous system conditions, and rare diseases. Established in 2013, the company provides a comprehensive platform featuring Interactive Response Technology (IRT), electronic Consent (eConsent), electronic Clinical Outcome Assessments (eCOA), and ePatient solutions, all aimed at streamlining essential patient interactions. Their innovative software design guarantees a fluid user experience, enabling accurate randomization, efficient drug supply management, and immediate data collection. With a strong commitment to improving patient understanding and alleviating the demands on trial sites, Suvoda's offerings are designed to evolve alongside the increasing complexities of clinical trials. Based near Philadelphia, with additional offices across Europe and Asia, Suvoda has successfully supported over 1,500 trials in more than 85 countries, showcasing their global reach and expertise in the field. Their dedication to innovation and excellence positions them as a vital partner in the advancement of clinical research.

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.

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.

We offer a comprehensive tracking solution designed specifically for clinical trials. With a simple download onto your trial managers' mobile devices, you can relax as TruLab's advanced blockchain technology handles all the complexities. There's no need to wait for samples to arrive at a central lab to identify potential issues; instead, you can detect data anomalies in real-time as samples progress through the clinical trial process. TruLab facilitates continual remote accessioning of samples, addressing the significant concern that 20% of samples are either lost or deemed unusable during late-stage trials. This situation is unacceptable from ethical, logistical, and financial perspectives. Furthermore, with sample collections increasingly taking place at participants' homes, new challenges in tracking these samples arise. TruLab effectively monitors samples wherever they are located, ensuring that they are accounted for from residences to repositories, thus enhancing the overall integrity of the clinical trial process. By providing seamless tracking capabilities, TruLab empowers trial managers to mitigate risks and improve outcomes.

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.

IVR Clinical Concepts is a company that focuses on offering technology for virtual clinical trials and solutions for patient engagement. Their products feature electronic patient-reported outcomes and patient diaries, which are designed to enhance data quality by minimizing errors, thereby shortening timelines and reducing overall costs. Furthermore, they provide comprehensive patient recruitment and outreach services that emphasize outreach, pre-screening, and the collection of real-time data. The solutions for subject screening, registration, and randomization are characterized as modular, tailored, adaptable, and customizable. In addition to these services, IVRCC also delivers clinical trial material management solutions aimed at lightening the workload while ensuring greater control, along with eClinical integration services that work to unify data seamlessly. Their chart review services offer insights based on real-world data and clinical experiences. By prioritizing custom, modular, and adaptable solutions, IVRCC strives to enhance the patient experience and maximize the success rates of clinical trials. This commitment to innovation positions IVRCC as a leader in the industry, dedicated to improving the efficacy of clinical research.

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.

Electronic source documents, known as eSource, replace traditional paper methods, streamline workflows, and minimize the likelihood of errors and omissions. BREEZE eSource transcends basic visit templates and scheduling functionalities. By aligning clinical contexts with regulatory and protocol requirements, along with study procedures, BREEZE eSource ensures users effectively capture all necessary data mandated by the protocol. The business rules within BREEZE guarantee that data collected are not only correct but also complete, precise, and compliant with relevant standards. Our team of clinical trial specialists creates tailored eSource documents specific to each study for review and approval prior to the trial's initiation, providing ongoing support and adjustments throughout the study duration. The individual modules integrate flawlessly, working in unison to enhance efficiency. The Cross-Module Action Multiplier further elevates functionality by predicting and automatically fulfilling supplementary tasks based on user inputs, such as automatically recording completed visits or procedures, which then updates invoicing and recalibrates scheduling effortlessly. This interconnected approach not only simplifies trial management but also enhances overall data integrity and operational effectiveness.

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.

Historically, managing clinical trials at investigator sites involved either the cumbersome task of maintaining numerous shared spreadsheets or investing in costly software that often did not fit the Australian context. MAISi represents a revolutionary shift in this landscape. Originating in 2001 as a data repository for clinical trials at a prominent hospital, MAISi has transformed into an advanced workflow application designed to streamline various functions within research units. Serving as a centralized database, MAISi efficiently organizes information related to studies and the corresponding business units that manage them. This structured approach enhances management decision-making capabilities. Individual staff members within each business unit can access specific data pertaining to their studies, patients, investigators, and study team members, while those with broader access rights, typically Financial Officers and System Administrators, can view comprehensive data across all units. Additionally, this streamlined access promotes collaboration and improves overall operational efficiency.

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.

Document management and teamwork are streamlined with myClin, which serves as an interactive and dynamic eTMF solution. You can swiftly upload and share research documents through your secure and centralized myClin channels, facilitating immediate access that speeds up the distribution of essential study updates and training information. With oversight built into the process, our "File it" feature allows you to monitor who has reviewed and comprehended your study materials. This feature not only serves as a record of effective study execution but also tracks training activities such as views, filings, or downloads at both the team and individual levels. Always be prepared for inspections, as our compliance score highlights the engagement levels of each site or study team member with relevant study information. This proactive approach directs you to areas of lower compliance within your study, fostering ongoing improvements in risk management practices. In just a few hours, we can set up a myClin channel for you to explore myClin with your team, making the process exceptionally straightforward. Experience the ease and efficiency that myClin brings to your study management today.

Research teams are facing rising demands to achieve greater outcomes with limited resources. The progress of a trial can be significantly hindered by issues such as disconnected systems, the necessity for manual data entry, repetitive workflows, and fragmented information. Thus, it is essential to adopt a clinical trial management system that integrates and optimizes workflows while ensuring complete transparency, and Medidata offers the perfect solution. Rave CTMS stands out as the sole data-centric platform designed for efficient and intelligent end-to-end trial management. As a key component of the Medidata Rave Clinical CloudTM, it encompasses all the features you would expect from a top-tier CTMS and even more. Rave CTMS empowers your study teams to plan and oversee all clinical trials consistently and cohesively, standardizing activity planning and management across study, country, and site levels. This includes managing the creation and activation of study/site teams, tracking patient enrollment and milestones, monitoring sites, and addressing issues effectively. Moreover, with Rave CTMS, you can enhance collaboration and communication among team members, which ultimately leads to better trial outcomes.

Experience total oversight and effortless management with LifeSphere CTMS, a user-friendly solution crafted for clinical operations teams to enhance efficiency, maintain organization, and simplify processes. This modern cloud application is designed to shorten study timelines by streamlining management and automating essential tasks throughout the trial life cycle. Tackle the intricacies of clinical studies with an intuitive yet robust trial management tool that ensures comprehensive visibility of all trial activities, keeping study teams synchronized and punctual. Enhance your clinical operations with this all-in-one platform, which encompasses payment processing and monitoring, while also ensuring a smooth integration with LifeSphere eTMF. Additionally, achieve compliance with the TMF Reference Model Exchange Mechanism Standard, facilitating effortless document sharing across various platforms, thus further optimizing your clinical workflows. With LifeSphere CTMS, you can elevate your clinical trial management to new heights of efficiency and collaboration.

Enhance the quality of data management by directly capturing eSource data during patient interactions. This process incorporates integrated editing and validation mechanisms, allowing users to electronically gather high-quality information, which significantly minimizes errors and inquiries, while facilitating real-time remote oversight. By doing so, the study duration, expenses, and risks are significantly reduced. FDA-endorsed, this innovative eSource approach simplifies and modernizes clinical trials, effectively replacing slow, error-prone monitoring and the transcription process into electronic data capture (EDC) systems. Additionally, tailored for site users, ez-SourceDocx optimizes workflows, alleviates workloads, and ensures adherence to study protocols by guiding sites through properly sequenced visit procedures, which not only confirm the collection of all endpoint data but also encourage timely quality assessments by investigators. Ultimately, this comprehensive system enhances overall clinical trial efficiency and reliability.

Discover a comprehensive platform designed for researching, documenting, and organizing your clinical data seamlessly. The Nucleus platform streamlines your research data management, providing a unified space for storing study documentation, clinical datasets, submission materials, and compliant media. With Nucleus Documents, you can efficiently manage documents and maintain version control for your quality documentation and media assets. Easily oversee, manage, and share your organizational content without hassle. Additionally, effortlessly compile and regulate your electronic trial master file documents through our centralized regulatory document management system. Nucleus Coding facilitates dictionary term coding for both MedDRA and WHODrug dictionaries, available as a standalone application or integrated within your data capture system, ensuring flexibility and efficiency in your coding processes. This comprehensive solution not only enhances data integrity but also optimizes collaboration across your research teams.

ClinAccess™ 5.1 represents the evolution of our premier Clinical Data Management System, built entirely on the robust SAS® 9 platform. This innovative system paves the way for streamlined clinical data management, efficient clinical trial analysis, and seamless preparation of electronic submissions. By integrating data entry directly into SAS® data sets, it significantly boosts your team’s efficiency by removing the cumbersome process of transferring data from Oracle/SQL to SAS. ClinAccess™ is specifically tailored for user-friendly study definition, data entry, and management, featuring tools that track the progress and quality of ongoing clinical trials. Your data is consistently maintained in SAS® for easy access, whether for review, analysis, or submission to the FDA. The underlying database architecture is optimized to facilitate rapid statistical analysis and reporting. Consequently, users can expect reduced time and effort in data analysis, ultimately leading to a faster time to market. Additionally, ClinAccess™ stands out for its reliability, comprehensive auditing capabilities, and robust security measures, making it an unparalleled choice for clinical data management. With ClinAccess™, you can confidently navigate the complexities of clinical trials while ensuring data integrity and compliance.

Medable offers an innovative software solution designed for the research and execution of clinical trials via a decentralized platform. This technology is focused on actively engaging patients remotely to ensure the collection of the most accurate results. Additionally, patients can conveniently provide their consent for digital assessments from a distance, and the platform is tailored to comply with local languages and regulatory requirements. Optimize the decentralization of your protocol with our adaptable, modular digital and decentralized clinical trial (DCT) platform. Facilitate extensive remote screening on a global scale and achieve your enrollment goals more swiftly. Create any type of screening assessment to fit your needs. Enhance the clarity of consent documents with responsive designs suitable for web and mobile devices. Deliver remote eConsent experiences to patients that rival popular consumer digital interfaces. With the capability to adapt to local regulations and languages, we offer global flexibility that accommodates diverse needs. By engaging patients and alleviating the challenges associated with travel and time constraints of on-site visits, you can significantly enhance patient access and involvement in the study. Ultimately, this approach not only streamlines the clinical research process but also prioritizes patient convenience and participation.

SimpleCTMS was created to deliver the advantages of a Clinical Trial Management System (CTMS) while avoiding the heavy initial financial and resource investments typical of conventional enterprise solutions, as well as the limitations posed by using spreadsheet trackers. This platform offers emerging drug developers a flexible and budget-friendly way to enhance the management, effectiveness, and initial costs of clinical trial operations. Clients benefit from the assistance of a dedicated manager who offers proactive support and strategic guidance. Additionally, all users can access technical help from our specialized team of clinical software professionals. While customized training and professional services are offered for an extra fee, the system is supported by a robust quality framework utilizing validated software processes, ensuring reliability and efficiency throughout its use. Furthermore, the emphasis on user support and tailored services reinforces SimpleCTMS’s commitment to facilitating successful clinical trials.

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.

Clario CTMS offers a user-friendly, comprehensive solution for managing clinical trials, enhancing control and efficiency in both data management and workflow while delivering high-quality data for every study, which ultimately leads to significant savings in time, labor, and operational costs. This cloud-based system allows users to access and oversee real-time operational metrics from anywhere at any time, ensuring flexibility in trial management. By utilizing a Microsoft Office-based work environment, Clario CTMS streamlines fragmented clinical trials into a unified and productive workspace, leveraging the familiarity of the most popular office tools globally. The smooth, bi-directional data transfer between Clario CTMS and SharePoint, along with other Microsoft products, creates a robust and efficient platform. Additionally, merging Office functionalities with clinical workflows helps minimize administrative tasks, decrease back-office documentation, and achieve a notably reduced total cost of ownership for organizations. The integration capabilities of Clario CTMS not only enhance operational efficiency but also foster collaboration among teams working on clinical trials.

We provide a range of solutions, from straightforward turnkey options to extensive multi-site research projects, assisting principal investigators in navigating the typical challenges associated with database configuration and selection. Researchers frequently turn to QuesGen for expert guidance on optimal data management practices and for supplementary services that facilitate the swift launch of their studies. As a seasoned collaborator for numerous academic institutions and researchers, we excel in handling sizable datasets and performing data curation through our adaptable data platform. This capability allows for the rapid and seamless initiation and expansion of research projects. With an all-encompassing data model, a library of assessments, and expertise in curation, QuesGen is dedicated to ensuring that you are operational quickly while guaranteeing high-quality, compliant data, enabling you to concentrate on analyzing your findings. Our solutions support various clinical research efforts within your organization, adhering to HIPAA and FDA 21 CFR Part 11 requirements, and they can seamlessly integrate with your electronic medical records system and the Federal Interagency TBI Repository (FITBIR). By leveraging our services, researchers can enhance their efficiency and streamline their workflows, ultimately leading to more impactful research outcomes.

Complion's platform was designed for clinical researchers. Our solution ensures compliance at the highest level with the lowest effort and the most efficiency. This allows you to concentrate on what really matters: improving and advancing patient outcomes. Our eReg solution is available to all clinical trial stakeholders, whether you are a Sponsor, Research Site or CRO. Reduce costs, avoid redundancy and increase staff productivity. You can easily archive, view and get signatures from any device. An audit trail is built into the system to ensure accuracy and eliminate patient safety risks and study conduct. Our clients include hospitals, cancer centers, and medical centers as well as multi-specialty clinics and dedicated research sites.

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.

EasyTrial.net is an online platform that allows you to access study data anytime and from anywhere. With this system, you can easily engage others by utilizing individual access controls that let you share specific information while restricting access to other data as needed. Moreover, EasyTrial.net adheres to GDPR regulations, ensuring that your data is stored securely. As the principal investigator, you maintain complete control over your data, while EasyTrial.net acts as the data processor, ready to establish data handling agreements upon request. Our expertise lies in data security, with a strong emphasis on IT and cyber protection. Over the years, thousands of clinical trials have been conducted within EasyTrial.net, earning the trust and approval of numerous data regulation authorities, hospitals, and educational institutions across various countries, which attests to the platform's reliability and security. This extensive experience further reinforces our commitment to safeguarding your sensitive information throughout the research process.

AutoCruitment offers an innovative, web-based platform that directly connects with patients, efficiently recruiting, qualifying, and automatically directing the most suitable candidates to clinical trials. By integrating advanced global recruitment technologies, it streamlines the process of finding, screening, and referring patients without relying on the traditional hurdles of provider consent, access to medical records, or investigator site involvement. Utilizing sophisticated online behavior analysis and geotargeting across over 1,500 digital channels—including search engines, display ads, social media platforms, and mobile partnerships—it effectively reaches and pre-qualifies patients in real time through tailored online screening tools that adhere to specific inclusion and exclusion criteria. Research facilities benefit from a secure and intuitive portal that provides immediate referrals, customizable reporting options, and live-tracking dashboards. Additionally, dedicated teams for project management and site engagement collaboratively work to enhance randomization rates, ensuring a more efficient trial process overall. This comprehensive approach not only improves patient recruitment but also fosters stronger connections between research sites and potential trial participants.

The platform features a sleek and user-friendly design, ensuring that navigation and data entry are both swift and effortless; it incorporates access control measures and SSL encryption for security, operates entirely online without the need for installations, and includes built-in monitoring alongside tools for data management and reporting, with a monthly flat rate (SaaS) that is customizable based on the size and duration of the study. Data collection is accelerated through an accessible web interface, allowing users to easily review the status of data completion with visual indicators, while it also employs edit checks and both automatic and manual queries to identify any discrepancies; additionally, it offers source data verification (SDV) and remote reviews through integrated buttons, meticulously tracking all changes made, including the author, date, time, and reason for each modification, and it can generate datasets (e.g., CSV) for subsequent statistical analysis, providing a comprehensive solution for research needs. This robust functionality ensures that users can efficiently manage their data while maintaining high standards of accuracy and security throughout the research process.

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.

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.

Oversee your clinical trial seamlessly through a single platform. Zapclinica offers an eClinical suite tailored to manage and execute every facet of your decentralized clinical trial—whether hybrid or entirely virtual. By automating intricate processes, it helps in spotting anomalies, optimizing resources, and enhancing decision-making alongside collaboration among sponsors, CROs, and study sites. This comprehensive solution significantly cuts down the time and expenses associated with running a successful clinical trial. With Zapclinica, you can handle all study components without the need for additional vendors or third-party services; instead, select the necessary applications within one unified environment, including EDC, ETMF, Payments, Logistics, and much more. Embrace the efficiency of a single platform to streamline your clinical research efforts.