Alternatives to Intrinsic CTMS

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.

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.

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.

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

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.

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.

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.

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.

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.

The premier clinical trial management system, specifically designed to overcome the technical challenges of managing clinical trials. CTMS Master makes it easier for users to communicate, reduces manual work, and eliminates redundant data and tasks. This allows for more efficient trial conduct. A Site Visit Report tool that integrates with an automated workflow eliminates duplicate data entry. It also facilitates the creation and distribution of out-of-the box Site Visit Reports (SVR). Standard templates can be used for site and project documents, budgets, events, milestones and site visit reports. CTMS Master offers more than 100 metrics/statistics to help you track clinical study sites, countries, and projects. It also includes 80+ standard reports and ad-hoc reporting capabilities. CTMS Master allows you to create site-specific budgets using a default template, track accrued and future obligations, and define automatic or manual approval for each payment type.

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.

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.

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.

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.

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.

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.

Korio serves as a versatile platform for Randomization & Trial Supply Management (RTSM), emphasizing adaptability, high standards, and efficiency. It is engineered not merely to respond to the challenges of clinical trials but to proactively avert them from arising. Regardless of the trials encountered, Korio is equipped to manage them effectively. Traditional RTSM systems struggle to accommodate the growing complexity of study designs, and inflexible platforms fail to implement necessary RTSM design modifications swiftly in response to clinical trial adjustments. Drawing from extensive practical experience, Korio has created an RTSM solution where adaptability and dependability coexist, blending innovation with seasoned expertise. Enhance your operational efficiency through Korio's user-friendly, role-specific interface, which empowers a diverse range of users—from site personnel and supply managers to clinical operations and data management teams—to work more efficiently and confidently. With Korio, enjoy a consistently managed trial experience that can adapt to your evolving needs. Ultimately, Korio is not just a tool, but a comprehensive solution for modern clinical trial management.

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.

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.

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.

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.

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

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.

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.

Teckro's clinical trial software seamlessly links all participants in a study to essential information, ensuring accessibility anytime and anywhere. With the convenience of smartphones, we uncover solutions daily—so why not apply that to clinical trials? Research staff and CRAs can access vital, current study data precisely when and where they require it. With just a tap on any mobile device, crucial details are readily available, providing a straightforward connection for research personnel. Additionally, site staff and monitors receive real-time alerts for any necessary updates or changes. Teckro's cloud-based clinical trial software is quick to implement, requiring no installation, and is designed to be user-friendly and intuitive. Furthermore, the platform is securely hosted and adheres to key industry standards, including FDA 21 CFR Part 11. By ensuring that only the correct, approved versions of study documents are available, Teckro eliminates the stress associated with managing document versions. This innovative approach not only enhances efficiency but also fosters collaboration among all stakeholders involved in the clinical trial process.

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☁️ .

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.

Enhance the efficiency of clinical trial operations by optimizing, automating, and analyzing data from all study management activities. Siebel CTMS offers a robust, scalable, and unified trial management platform designed to elevate operational productivity by standardizing workflows in clinical operations while delivering immediate data visibility. With Siebel CTMS, you can oversee and direct trial operations effectively from inception to completion, ensuring a seamless management experience. The system enhances data integrity by allowing customization of workflows to align with specific customer needs across various research studies. Furthermore, Siebel CTMS seamlessly integrates with sophisticated analytics tools that deliver prompt, data-driven insights into clinical programs, empowering you to make well-informed business choices. Accessing accurate and comprehensive clinical trial data in real-time enables swift and efficient decision-making, ultimately leading to improved outcomes in trial management. By leveraging these capabilities, organizations can significantly enhance their operational agility and responsiveness in the competitive clinical research landscape.

eClinical Solutions empowers global life sciences organizations to enhance their clinical development efforts through specialized data services and the elluminate® Clinical Data Cloud, which serves as the backbone for digital trials. This platform is utilized by over 100 biopharmaceutical firms and is specifically designed to hasten the digitization process, enabling companies to adeptly handle the increasing volume, variety, and velocity of clinical data. As noted in Gartner’s 2022 Hype Cycle for Life Science Clinical Development, life science firms are rapidly advancing their digital capabilities, with the widespread integration of hyperautomation, artificial intelligence, and sophisticated analytics. By utilizing elluminate’s automated data pipeline and flexible infrastructure, organizations can navigate the intricacies of contemporary clinical trials, ultimately generating significant business value across various clinical development areas. The ability to adapt and thrive in this rapidly evolving landscape is crucial for maintaining a competitive edge in the industry.

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.

Our clinical trials management platform is designed to accommodate nearly any type of controlled clinical trial, including those that are randomized, and offers a variety of randomization algorithms. This software can be effortlessly set up for both paper Clinical Report Forms (CRFs) and electronic CRFs (eCRFs). It is capable of capturing data in numerous formats and methods, applying specific guidelines you establish to ensure data integrity and quality control. The system facilitates direct Electronic Data Capture (EDC) through eCRFs or allows for the printing of paper CRFs that can later be input into the platform. Additionally, users can upload various media such as images, audio, video, and documents like consent forms, with the only limitation being the available storage capacity. The system supports Double Data Entry and features comprehensive exception reporting. Moreover, it includes a functionality to lock records after they have been verified, ensuring that no further alterations can be made. This robust capability enhances the overall integrity of the data collected throughout the trial process.

Ofni Clinical serves as an efficient clinical data management solution that swiftly develops and deploys secure databases for clinical trials that meet regulatory standards. This tool offers an array of robust search and reporting functionalities, alongside powerful data validation and edit check mechanisms, ensuring high-quality data handling. With its adaptable customization options, Ofni Clinical can be set up quickly and affordably, making it an attractive choice for researchers. The system is capable of collecting data from both traditional paper Case Report Forms and modern electronic data capture systems. Many Ofni Clinical implementations can be completed in under a month, taking projects from inception to a validated state. Reach out to us today to discover how Ofni Clinical can enhance your clinical trial processes, allowing for a seamless transition from your existing CRFs while minimizing training and implementation costs. Additionally, its extensive features for edit checks and data validation help in pinpointing dubious data entries and facilitate comprehensive data analysis. Users can expect a streamlined experience that supports their research objectives effectively.

CSAM Studies, formerly known as MedSciNet Studies, is a robust and highly adaptable online platform that has demonstrated success in managing clinical studies and trials for two decades. This web-based environment for medical research provides an advanced suite of applications designed for the hosting, administration, and oversight of projects varying in scale and intricacy. The standard offering from CSAM MedSciNet includes all essential elements necessary to establish a fully operational study or clinical trial. Additionally, this benchmark solution is equipped with features that facilitate dynamic and interactive data entry forms, customizable workflow structures, and sophisticated capabilities for data validation, analysis, and exportation. By leveraging these tools, researchers can ensure a comprehensive and efficient approach to managing their clinical studies.

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.

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.

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.

The in-system protocol serves as a comprehensive training program, integrated with fingerprint attendance for enhanced security. Cronos offers highly customizable workflows tailored for conducting various studies such as dermal, patch, and other bioavailability-bioequivalence (BA-BE) or early-phase research. It enables the capture, cleansing, and efficient management of study data, whether sourced from paper-based or electronic data capture (EDC) trials. Additionally, users can extract data into preferred datasets in compliance with industry standards like CDISC (SDTM). The EDC tool features real-time activity monitoring, and its Bedside Data Collection capabilities facilitate quicker, paperless assessments. Furthermore, Cronos includes a sample inventory and tracking system, ensuring a compliance-ready data repository. It supports data e-printing from nearly all BA instruments and software, along with an online review process complete with e-stamping and e-signatures within a defined workflow. Users can view projects, export, and archive data efficiently while generating high-quality statistical reports, tables, listings, and formats in both fixed and customizable layouts with remarkable ease. This robust system not only streamlines the research process but also enhances overall data integrity and accessibility.

EDGE, a cloud-based Clinical Trials Management System, has been successfully integrated into the UK's clinical research infrastructure and the devolved countries. Currently, EDGE is used in 80% of England's NHS regions, Scotland, and Northern Ireland. EDGE is the leading research management system in the UK. EDGE was launched in 2000 and adopted by the National Cancer Research Network. It has seen tremendous growth and has a growing number international subscribers from countries which include Canada, Belgium, New Zealand, South Africa and India.

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

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.

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.

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.

Clinevo's Clinical Trial Management System (CTMS) is a comprehensive, cloud-based platform designed to efficiently oversee every facet of clinical trials while being highly customizable. It adheres to all necessary regulatory standards, encompassing security measures, access management, change control protocols, audit trails, and system validation processes for optimal compliance and reliability.

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.

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.