Alternatives to Datatrial Nucleus

ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.

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.

Enhance the efficiency of regulatory operations within your organization to bolster compliance and facilitate research advancements. Veeva SiteVault simplifies the process of managing clinical trials by integrating your regulatory tasks, leading to improved effectiveness and adherence to regulations. You can oversee regulatory and source documents through a unified platform that complies with 21 CFR Part 11 and HIPAA standards. With real-time insights across all trials, SiteVault Enterprise boosts operational effectiveness, accelerates study initiation, and fosters swift, high-quality trial management. Transition away from manual workflows and customize your own processes to enhance both quality and speed in study activation. By granting monitors secure, direct access to your regulatory and source documents, you eliminate the hassles of EMR access and document redaction. Furthermore, you can tailor your workflows, generate reports, and create dashboards to gain deeper insights into start-up timelines and regulatory workflows, ultimately driving better outcomes for your clinical trials. This comprehensive approach not only streamlines processes but also enhances collaboration across teams.

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

WCG ClinSphere represents a groundbreaking method for conducting comprehensive clinical trials. By harnessing artificial intelligence, this platform seamlessly links sites, sponsors, CROs, and participants within a single cloud-based environment. It provides a centralized hub to effectively oversee your trial from inception to completion. The architecture of WCG ClinSphere is founded on four principles of efficiency that enhance its functionality. Our extensive clinical dataset fuels a federated AI learning model, facilitating intelligent automation throughout the clinical trial process. Users can access real-time reports and insights, ensuring they remain well-informed to make prompt decisions. Tasks are simplified, and accuracy is improved through intuitive workflows that provide guidance at every stage. The platform optimizes logistics, operations, and processes during the clinical research experience, ultimately leading to faster and more effective outcomes. With the integration of vast data resources and advanced analytics, WCG ClinSphere fosters the essential connections needed for accelerated clinical research advancements. The collaborative nature of the platform also encourages innovation and continuous improvement in 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.

A cloud platform that is accessible from anywhere, infinitely scalable, and powered by AI offers collaborative features while adhering to the strictest security and compliance standards. This user-friendly software, designed by specialists in neuroimaging and data science, addresses the specific and complex requirements of the neuroscience field. Customized to suit your particular needs, it supports a wide range of activities, including research, clinical trials, point-of-care applications, algorithm development, and the utilization of brain-related data. The platform facilitates global data aggregation and consolidates imaging studies into a single cloud environment. It provides an efficient, comprehensive management solution for clinical, real-world data, and medical imaging information. Users receive tailored, expert assistance throughout their studies to ensure successful outcomes. Additionally, it features centralized reading capabilities and the option to compare quantitative results against a normative database. The platform also guarantees high-quality, shareable reporting and data export options to streamline the submission approval process, making it an invaluable tool for neuroscience professionals. Furthermore, its innovative design enhances collaboration among researchers and clinicians, fostering a community dedicated to advancing the field.

SiteCentric is an integrated platform designed for clinical trial management, specifically created by research sites to address their unique needs, which combines various functions such as CRM, eISF, CTMS, financial management, and reporting into one cohesive system. This comprehensive solution streamlines and automates processes throughout the entire trial lifecycle, facilitating the nurturing of study leads and organization of pipeline activities with a specialized CRM. It also centralizes essential documents, including budgets, contracts, eReg, training records, and source documentation, to ensure a swift startup process. Additionally, it enhances enrollment efforts through targeted outreach strategies and by utilizing existing databases for more effective recruitment. The platform tracks patient visits meticulously while capturing high-quality eSource data, and conducts internal quality control checks along with maintaining version control and audit-ready eISF documentation. Furthermore, it oversees financial aspects such as budgets, invoicing, payment reconciliation, and patient reimbursements, while also providing leadership dashboards that reveal key performance metrics and trends in real-time, allowing research sites to make informed decisions quickly. Ultimately, SiteCentric empowers research sites by consolidating various functionalities into one efficient platform tailored to enhance clinical trial operations significantly.

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

TrialPoint™ electronic data capture (EDC) is highly adaptable and user-friendly, earning the approval of coordinators everywhere. Our skilled data managers specialize in transforming clinical protocols into accessible metadata dictionaries, ensuring that TrialPoint™ is tailored to your needs rather than hindering your processes. The platform is capable of accommodating any randomization string, media uploads, or coding dictionaries, and it has the functionality to obscure treatment assignments from users. To enhance timely data collection, the system proactively determines visit windows and dispatches alerts and reminders, helping to keep the entire team aligned and on track. In the current landscape, incorporating patient-reported health outcomes and quality of life questionnaires is common in clinical trials, often leading to protocol adherence challenges. Explore TrialPoint's electronic patient-reported outcomes (ePRO) module, which can be customized to accommodate any quality of life questionnaire or patient diary, providing a seamless experience for participants. Ultimately, this flexibility not only facilitates compliance but also enhances the overall quality of the data collected in clinical trials.

The Medidata Clinical Cloud represents our innovative platform designed to revolutionize the clinical trial journey for patients, sponsors, CROs, and research institutions. As the sole comprehensive technology solution focused exclusively on clinical research, the Medidata Clinical Cloud addresses the entire research spectrum from inception to completion. Our platform enables organizations in the life sciences and medical device sectors to reduce development expenses, manage risks effectively, and expedite the introduction of treatments and devices to the marketplace. Whatever selection you make for your clinical trial initiatives, you will benefit from the capabilities of the Medidata Clinical Cloud. At Medidata, we are at the forefront of the digital evolution in clinical research. With the power of artificial intelligence, machine learning, and sophisticated analytics, our platform connects researchers, study coordinators, investigators, and patients, thereby hastening the research process. Additionally, it provides a regulatory-compliant, patient-friendly electronic informed consent solution for clinical trials, ensuring a smoother experience for all parties involved. This integration of advanced technology not only streamlines operations but also enhances the overall quality of clinical research.

Cloudbyz CTMS is a cloud-based trial management platform natively built on Salesforce Cloud. It is aimed at sponsors, clinical research organizations (CRO), and clinical sites for managing end-to-end clinical trial operations. Designed for clinical research, it expedites implementation and drives user adoption. Cloudbyz CTMS comes with an intuitive, straightforward design that allows for quick deployment. Boasting a rich set of features, Cloudbyz CTMS makes it easy for users to manage all aspects of clinical trials, including sites, enrolment, documents, events, milestones, site visit reports, finances, inventory, etc. The solution benefits are listed below- 1. Secure, reliable & scalable 2. Faster time to value 3. Monitor study progress & risks from planning to close-out 4. Seamless collaboration among sponsors, CROs & sites 5. Improved clinical team efficiency

VACAVA offers healthcare solutions that simplify and reduce the costs associated with managing regulatory documents for clinical trials. The reliance on manual workflows can lead to delays and the risk of losing important information whenever documents are transferred. By utilizing VACAVA's solutions, you can enhance your regulatory processes by centralizing profiles, forms, and documents in a single, easily accessible online platform. With electronic approvals in compliance with 21 CFR Part 11, documents transition smoothly throughout your workflow. User-friendly dashboards provide efficient oversight, making management straightforward. Developed in partnership with a leading clinical trial research organization, VACAVA’s Regulatory Document Management System is designed to streamline operations and significantly boost efficiency. Additionally, it is surprisingly cost-effective and can be tailored to suit your specific requirements. VACAVA’s offerings are not only flexible and scalable but also delivered through the cloud, eliminating concerns about server management, security, and data backups. This means organizations can focus more on their research and less on technical hurdles.

SimpleTrials is a subscription-driven, on-demand Clinical Trial Management System (CTMS) tailored for sponsors, Contract Research Organizations (CROs), and research sites. It encompasses a wide array of tools designed to efficiently plan, oversee, and monitor clinical study portfolios, featuring capabilities such as site initiation and subject monitoring, document management through an integrated electronic Trial Master File (eTMF), real-time analytics for studies, comprehensive calendars and monitoring options, customizable fields and trackers, on-demand reporting, planning milestones, management of site contracts and payments, as well as electronic visit documentation. The platform is built to ensure compliance with 21 CFR Part 11 and establishes a secure, validated space for handling clinical trial data. Users benefit from the ability to personalize tracking views, connect with various Electronic Data Capture (EDC) systems, and access pre-built templates for uniform document management. Furthermore, the system enhances collaboration among stakeholders, facilitating smoother communication throughout the trial process.

Streamline your document workflows to eliminate inefficiencies that consume valuable time and resources, hindering your growth and ability to secure new studies. Florence eBinders seamlessly connects all your clinical trial systems, automates eRegulatory tasks, shortens contract negotiation duration, monitors study advancement, and facilitates secure remote oversight on a leading eRegulatory, eISF, and eSource platform. With our highly-rated implementation and support teams, your team and study can be set up quickly, ensuring a smooth transition for all users. Most sites become fully operational within just four weeks! By enabling secure access for your monitors and providing remote capabilities for your team, you can significantly decrease the time spent on-site during monitoring visits. Additionally, this approach fosters a more efficient and flexible research environment.

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

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.

RealTime-CTMS stands out as a leading, cloud-driven clinical trial management system designed specifically to enhance both efficiency and profitability for research sites and site networks. It features a suite of fully-integrated services, such as RealTime-PAY, RealTime-TEXT, and RealTime-eDOCS, which is the first fully-integrated eRegulatory document management system, facilitating faster and easier access to study or subject information through a user-friendly interface. In addition to these offerings, RealTime-CTMS provides a variety of other solutions, including online document storage, appointment reminders, data collection, and payment processing, ensuring comprehensive support for clinical trial management. This extensive array of features makes RealTime-CTMS an invaluable tool for improving the overall workflow within clinical research environments.

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.

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.

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.

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.

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.

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.

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.

Phoenix CTMS is a comprehensive, web-based clinical research platform that integrates Patient Recruitment System (PRS), Clinical Trial Management System (CTMS), and Clinical Data Management System (CDMS) capabilities into a single modular solution. The platform is designed to address the full spectrum of operational and regulatory demands faced by academic researchers, CROs, and hospitals running clinical trials at any phase. Phoenix CTMS provides a secure, private registry for sensitive patient data, ensuring compliance with EU-GDPR and other data privacy regulations. It supports a highly flexible electronic data capture (EDC) system with unlimited JavaScript form scripting for both server and browser, making it ideal for managing complex and large electronic case report forms (eCRFs). Users can conduct parallel trials while efficiently organizing site staff and resources through an intuitive interface. Unlike many commercial EDC packages, Phoenix CTMS is an open source project under LGPL 2.1, developed in collaboration with clinical trial sites at the Medical University of Graz. It is designed as a turnkey system that is operational out-of-the-box, eliminating the need for integrating multiple disparate tools. The platform is particularly suitable for users seeking a secure, private, and customizable clinical trial management solution.

BSI CTMS impresses with its innovative interface and intelligent visualization of data. Our clinical trial management software is more than just an attractive interface. It includes functions that assist pharma, biotech, and diagnostics sponsors as well as CROs and academics (SMOs) in their daily lives for managing clinical trials in a targeted manner. BSI CTMS continues to be developed based on market needs and in close collaboration. BSI CTMS is unique because it offers CTMS, eTMF and Study Startup functionality in one integrated platform. Excel and other standalone solutions are overrated.

Most Easy-to-Use Clinical Trial Management System (CTMS) 𝐂𝐥𝐢𝐧𝐢𝐨𝐧 𝐂𝐓𝐌𝐒 integrates seamlessly with Clinion EDC and Clinion RTSM to provide detailed and faster access to the entire trial process to address all aspects of Clinical trial management from a single platform: investigator sites, patients enrollment, SAEs, deviations, inclusions, visit scheduling, IP management, milestones, finances, custom reports, and on-demand analytics enables you to improve quality, control risk, and reduce costs. Clinion CTMS is modular in design These modules are available: Admin Module Project Management Site Monitoring Activities Finance and Budget Management Safety Reporting Management of IP Inventory Document Management System Audit/Activity Log Comprehensive dashboards Comprehensive Reports

Harnessing actionable insights from the leading AI-driven clinical analytics platform allows your teams to effectively manage risk and enhance performance throughout studies, systems, sites, and vendor relationships. The cutting-edge technology from Saama is specifically crafted to optimize workflows, automate labor-intensive tasks, and foster improved collaboration among various clinical functions such as operations, medical review, data management, biostatistics, and pharmacovigilance. Both sponsors and CROs depend on Saama's capabilities for data aggregation and AI solutions, which facilitate superior decision-making, minimize delays, and drastically reduce costs and timelines associated with drug development. By leveraging Saama's tools, you can accelerate the pace of clinical trial innovation. When your clinical data is centralized and continuously updated, it simplifies the lives of your ClinOps and medical review teams considerably. Furthermore, Data Managers, often undervalued, can shift their focus from repetitive tasks to the critical data points that truly drive project success, ensuring that their expertise is fully utilized in the process. This transformation not only enhances efficiency but also contributes to the overall quality of clinical outcomes.

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.

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.

Clinical Conductor CTMS (Clinical Trial Management System) is a cutting-edge system for managing clinical trials. It's suitable for hospitals, research sites and asset management companies. Site networks, health systems, contract research organizations (CROs), and other healthcare facilities. This cloud-based solution makes clinical trials more efficient and helps research organizations make better business decisions. The key features include electronic data capture and enrollment management, document management, recruitment management, and many more.

In the realm of clinical research, effective organization is a fundamental component of achieving success. Ensuring that the appropriate resources are utilized at the optimal moment presents its own set of challenges, especially concerning document management within a clinical trial. GRAVITY stands out as a long-standing solution for managing site files and trial master files. We have transformed both types of documents into a user-friendly, coordinated electronic format. This comprehensive package enhances document management by providing a logical and convenient framework. As an integrated eTMF and eISF system, GRAVITY serves as a complete cloud-based electronic Document Management System (DMS), acting as a hub for sponsors, CROs, and sites alike. Furthermore, GRAVITY can also function independently for each individual entity as needed. Once a site is chosen to conduct a clinical trial, the influx of documents begins, and the initial set of critical documents necessitates careful management. GRAVITY features a distinctive capability that allows it to monitor essential document management while also notifying users about any documentation that is nearing expiration, ensuring compliance and efficiency throughout the trial process. This proactive approach not only streamlines operations but also enhances the overall quality of clinical research.

LifeSphere eTMF serves as the definitive source of truth for your clinical trial. Experience a flexible solution that simplifies inspections, guarantees compliance, and reduces the time and effort required by your organization. As the pioneering system designed to adhere to the TMF reference model, LifeSphere eTMF integrates clinical documentation with regulatory requirements and study protocols into a unified platform. Establish and oversee a singular source of truth for your clinical trial to enhance efficiency. With features that promote live collaboration and real-time document sharing, you can ensure the quality, timeliness, and completeness of your trial master file. Expedite TMF inspections swiftly and effectively to manage audits seamlessly. Furthermore, uphold compliance through built-in workflows and intuitive dashboards that facilitate straightforward trial reconstruction, making the process smoother for all stakeholders involved.

Omda MedSciNet solutions enhance the quality, usability, and administration of medical data throughout its lifecycle from collection to analysis. This secure and standardized software streamlines the process for clinical researchers and other professionals in healthcare and academia, allowing for the efficient gathering and examination of well-organized medical data. The dedicated Omda team excels in the development and management of customized database applications, as well as designing clinical studies tailored for medical research and quality registries. The Omda MedSciNet study platform offers a dependable, feature-rich, and highly adaptable online environment suitable for hosting and managing complex study and clinical trial systems. With a proven track record spanning 20 years, Omda MedSciNet has effectively supported studies and clinical trials of various scopes and sizes. Standard implementations come equipped with a comprehensive array of components essential for launching fully functional studies or clinical trials, ensuring that researchers have all the necessary tools at their disposal. This commitment to quality and customization positions Omda MedSciNet as a leader in the field of medical data management.

Medilake is your premier solution for comprehensive clinical and non-clinical trial data management We are pleased to introduce Medilake, a versatile and innovative platform that excels at the seamless management of clinical trial and nonclinical trial data. Medilake is the best choice to simplify, optimize, and enhance data management processes in an era when data is the lifeblood for healthcare and research. Why choose Medilake to manage clinical and non-clinical trial data? Unified Data Hub - Streamlined collaboration - Data Integrity & Security Advanced Analytics - And Customization and Scalability

With more than two decades of expertise in the fields of software publishing and clinical research, Arone delivers a comprehensive array of tools designed for the efficient entry and management of patient data for clinical research organizations. Our solutions are ready to use, and we offer tailored support to ensure your projects and studies are conducted effectively. Utilize a unified platform to gather and oversee patient data seamlessly. Arone facilitates patient randomization by randomly designating treatment types to study participants, which helps eliminate bias in research outcomes. Enhance the engagement of clinical trial participants by enabling them to enter their daily data conveniently. Additionally, our personalized support enhances the overall success of your research projects. Together, we strive to innovate and improve the clinical research landscape.

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.

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.

AcceleTrial™ eliminates uncertainties in identifying and activating clinical trial sites. Our Study Start-up Management System (SSMS) relies on objective data rather than self-reported information. With AcceleTrial™, you gain access to a comprehensive database of thousands of globally ranked and indexed sites, evaluated based on their specific therapeutic expertise, clinical trial experience, and patient data. This system allows for an objective pairing of the most suitable sites worldwide with the relevant data on expertise, experience, and patient demographics for your clinical trials. You can swiftly engage the right sites to commence patient enrollment through AcceleTrial™'s automated “push and pull” functionality, available in multiple languages. The platform simplifies the process of gathering necessary documents with pre-filled templates and enables real-time tracking of activities. You can begin utilizing the system immediately, as it is a cloud-based solution that requires minimal IT infrastructure or training. Moreover, AcceleTrial™ can be seamlessly integrated with CTMS or other existing clinical trial management systems for enhanced efficiency. This ensures a streamlined approach to clinical trial management, allowing researchers to focus on their core objectives.

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

Experience a comprehensive and integrated solution with our Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS), and Electronic Data Capture System (EDC) all combined. With our advanced and adaptable Clinical Trial Software System, all your research information is easily accessible. You have the choice to host Clindex® on your own servers or utilize the Fortress Medical Cloud (SaaS – Software as a Service) for convenience. Global cloud access ensures that your data remains securely housed in a SOC 3 certified data center. Whether you prefer to create your own study database or require assistance, Clindex® equips you with all the necessary tools. Our straightforward quick start manuals and comprehensive help documentation guide you meticulously through the setup process. Alternatively, you can rely on our dedicated Clindex services team to design a study tailored to your needs, ensuring a smooth and efficient experience.

Speeding up the creation of crucial medications and ensuring that patients worldwide can access top-notch cancer treatment and research equally. Our technology is transforming how patients access cutting-edge medicines and participate in clinical trials. FICS is a groundbreaking software solution that facilitates the gathering of regulatory-compliant data throughout patient treatment. By integrating previously isolated and non-interacting applications into a comprehensive, seamless platform, FICS is making clinical trials more efficient, quicker, and of superior quality, ultimately enhancing patient outcomes in significant ways.

Progressing artificial intelligence to remove the need for trial and error in healthcare, our digital twins facilitate swift and assured clinical trials. We focus on areas such as neuroscience, immunology, and metabolic diseases, among others. TwinRCTs expedite full enrollment by requiring fewer participants to provide equivalent statistical power compared to conventional trial methodologies. This approach significantly reduces the time needed for late-stage study enrollment. Additionally, TwinRCTs enhance the ability to detect treatment effects in early-stage studies by bolstering statistical power without necessitating an increase in participant numbers. They enable researchers to make informed decisions based on initial study outcomes and help attract more participants to trials. By utilizing smaller control groups, TwinRCTs also improve participants' odds of receiving the experimental treatment. Our commitment to positioning clinical trials with digital twins for regulatory success is unwavering. Unlearn is at the forefront of transforming the medical field through the innovative application of artificial intelligence, creating and implementing novel generative models that are trained on vast datasets derived from previous patient studies. This evolution in methodology not only streamlines research but also enhances the overall effectiveness of clinical trials.

Clinevo's electronic Trial Master File (eTMF) is a user-friendly digital solution for the organization and storage of documents, images, and various digital assets related to clinical trials. This eTMF incorporates an integrated DIA reference model and complies with regulatory standards. Additionally, Clinevo offers the MICC Intake, a web-based platform designed for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) professionals to efficiently log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Furthermore, Clinevo Safety serves as a comprehensive cloud-based system that ensures ease of use and regulatory compliance throughout the entire Pharmacovigilance process, encompassing PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals, all within a single platform. Lastly, the Clinevo Website Intake tool can seamlessly integrate with Sponsor or CRO websites, offering consumers and reporters an intuitive web interface for easy access and reporting. This innovative suite of tools enhances the efficiency and effectiveness of clinical trial management and safety reporting.