Alternatives to LifeSphere CTMS

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.

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

LifeSphere NavaX serves as your entry point into a future where cutting-edge automation, artificial intelligence, and smart data analytics come together to transform your business and improve overall outcomes. Tailored for scalability and adaptability, LifeSphere NavaX collaborates with you to chart your path towards automation, aligning it with your specific objectives, aspirations, and timelines. You maintain control throughout the process, with the flexibility to enable or disable features as your needs evolve. This solution enhances existing LifeSphere offerings while seamlessly integrating with external systems, ensuring a fluid shift toward a more intelligently automated environment. Developed in partnership with leaders in the pharmaceutical and regulatory fields, LifeSphere NavaX upholds stringent quality and security standards through comprehensive governance and compliance measures. By automating routine manual tasks and workflows, it delivers significant time and cost efficiencies, boasting potential efficiency improvements of up to 50% on critical workflows. As a result, businesses can focus on strategic initiatives, ultimately leading to enhanced productivity and growth.

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

Introducing the latest version of eTMF Connect: a solution designed with simplicity at its core while ensuring no compromises are made. We have completely transformed eTMF Connect to deliver a faster, more scalable, and high-performing eTMF solution that meets the demands of both current and future clinical trial landscapes. Enhanced Data Visualizations & Reporting Features. Montrium has integrated a suite of advanced data visualization and reporting tools into eTMF Connect, significantly boosting its business intelligence capabilities. This functionality enables deeper insights across all studies, allowing project teams and clinical operations managers to gain improved visibility into TMF completeness, quality, and timeliness. As a result, these enhancements will elevate your TMF strategy across various clinical programs. Each clinical trial presents its own unique challenges, and the intricacies and regional variations involved can add significant complexity that might keep even seasoned TMF professionals awake at night. It is crucial for your eTMF platform to be adaptable enough to address these diverse challenges and intricacies effectively. By doing so, it ensures that your organization can navigate the complexities of clinical trials with confidence and precision, ultimately leading to more successful outcomes.

cubeCTMS is an all-encompassing clinical-trial management platform that facilitates complete oversight of trials, encompassing aspects such as tracking study sites and investigators, managing enrollment and visit schedules, and overseeing budget and contract workflows, as well as milestone reporting and document management. By centralizing study operations and automating essential processes, it allows sponsors, CROs, and study teams to oversee progress in real time, coordinate tasks across various studies, enhance communication with sites, and reduce risks. The platform offers integrated dashboards, notifications, and audit-ready documentation to ensure compliance with regulatory standards, including readiness for FDA 21 CFR Part 11, empowering stakeholders to oversee trial timelines, resources, and overall performance from a singular interface. Additionally, cubeCTMS seamlessly connects with other CRScube modules, such as EDC, eTMF, and pharmacy/RTSM, creating a cohesive ecosystem that minimizes redundancy, optimizes data flow, and supports flexible workflows during amendments or large-scale implementations. This integration not only streamlines processes but also enhances the overall efficiency of clinical trials, making it an invaluable tool for research teams.

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

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.

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.

LifeSphere Safety presents a cutting-edge, all-inclusive SaaS Safety platform designed to facilitate seamless case processing, enhance compliance scalability, and standardize pharmacovigilance practices globally. Catalyze significant transformations with top-tier features, incorporating the newest advancements in automation, analytics, and GenAI technologies, all driven by LifeSphere NavaX. Experience remarkable efficiency improvements through touchless case processing, utilizing potent, production-ready automation and AI to optimize routine safety operations. With unmatched turnkey support for both global and regional regulations, confidently navigate any market while benefiting from continuous cloud upgrades that guarantee ongoing compliance. Transform safety into a strategic asset by utilizing powerful, user-friendly resources for reporting, dashboard creation, operational benchmarking, and insightful signal analysis, ensuring your organization remains at the forefront of industry standards. Embrace the future of safety management with LifeSphere Safety's innovative solutions tailored to meet the evolving demands of the regulatory landscape.

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

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.

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.

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.

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

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.

LifeSphere Medical Affairs, a cloud-centric solution created by ArisGlobal, aims to boost efficiency, adherence to regulations, and teamwork among medical affairs teams. It features a consolidated workspace that integrates medical information management with safety and quality assurance systems, promoting comprehensive automation and instantaneous data exchange. This platform simplifies the collection and management of medical inquiries through various channels, automates the handling of product complaints and adverse events, and guarantees adherence to global regulatory standards that are constantly changing. With its sophisticated analytics and reporting capabilities, it delivers valuable insights that enhance data-informed decision-making and lead to better patient outcomes. LifeSphere Medical Affairs is also built to be both scalable and customizable, accommodating the specific requirements of organizations, regardless of their size. Furthermore, it empowers medical teams to operate more effectively in a dynamic regulatory landscape.

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.

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.

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.

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.

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

Sarjen offers a comprehensive suite of life sciences solutions designed to optimize clinical trial management and laboratory operations. BizNET streamlines early-phase trials with automation, security, and real-time monitoring, ensuring rapid, precise execution and compliance. For late-phase trials, Smart Trial Suite accelerates processes, reduces costs, and enhances patient safety through intelligent automation, real-time insights, and extensive modules like eTMF and eDC. Complementing these, the Bioanalytical LIMS automates lab workflows, ensuring data integrity, reducing errors, and accelerating data validation for regulated environments. Together, these GxP-compliant, audit-ready platforms boost productivity, ensure regulatory adherence, and drive efficient, high-quality outcomes across the entire drug development lifecycle.

Ripple, a web-based software solution that allows for the management and recruitment of research participants in clinical, translational, and social science studies is an active registry. Ripple was developed by researchers to transform the participant workflow. It is an end-to–end research participant management system that speeds up the entire research process.

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.

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.

Cloudbyz eTMF is a cloud-based solution that offers a repository of all clinical trials documents, including images, files, information, etc. Store, manage, and easily share all documents related to clinical trials in a digital format. Manage trial documents, remain inspection-ready, and provide real-time visibility to CROs and sponsors, as well as monitors and other stakeholders.

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.

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.

Intrinsic's Clinical Trial Management System (Intrinsic’s CTMS®) is thoughtfully crafted with the user experience in focus, aiming to reduce data input and enhance proactive oversight of studies. As a cloud-based platform featuring an efficient interface, it allows for comprehensive study management across various levels and employs a task-oriented approach, marking a significant advancement in trial management solutions. Notably, Intrinsic® is the pioneering CTMS that offers seamless integration with all Microsoft applications, including Outlook, Excel, SharePoint, and Power BI. The introduction of Dynamic Worksheets enables users to effortlessly import large sets of data and updates from CROs via their clinical trial management software, eliminating the need for complex system integrations, while also allowing for the generation of 'live' exports for on-the-fly analysis and reporting. Additionally, Intrinsic CTMS® harnesses the capabilities of Power BI, a cloud-based reporting tool, empowering users to create reports from other clinical systems, such as EDC and IRT, without the burden of developing expensive data warehouses. This innovative approach not only simplifies data management but also enhances the overall efficiency of clinical trial processes.

ImproWise is an entirely web-based platform that guarantees security and HIPAA compliance, specifically designed for comprehensive Clinical Trial Management (CTMS) and Clinical Data Management (CDMS). This innovative solution delivers unmatched flexibility, rapid performance, and robust security by integrating functionalities such as CTMS, CDMS, EDC, CTBM, CTPM, eTMF, ePRO, and RBACS. Tailored to address the requirements of all parties involved in clinical trials, ImproWise facilitates smooth collaboration among sponsors, investigators, data managers, data entry specialists, site personnel, and regulatory affairs experts, ultimately enhancing efficiency throughout the entire trial process. Furthermore, the platform's user-friendly interface makes it accessible for users of varying technical backgrounds, ensuring that everyone can contribute effectively to the trials.

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.

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.

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.

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

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.

TrialKit is a cloud-based platform available via both a web and native mobile app, enabling end-to-end clinical trial management for medical device, diagnostics, digital therapeutics, and biopharma companies of all sizes. Design and deploy validated studies in days not weeks using our intuitive study builder that requires no programming. Thousands of global users have leveraged the flexibility of TrialKit to deploy over 8,000 studies across all phases of development.

Cloudbyz EDC, a cloud-native application with an intuitive user interface, is designed to store and effectively manage clinical data throughout the life cycle of a clinical trial. Our innovative solution allows clinical research teams the ability to collect, analyze and manage clinical data that is of varying complexity and size. Create your study without coding, using an interface that allows users to create forms and navigate easily to the appropriate screens for data analysis and collection.

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.

Clinion's electronic trial master file (eTMF) system offers distinctive functionalities that enhance the ease of storage, retrieval, and oversight of documents. With its intuitive user interface, it stands out as the preferred solution for managing clinical trial documentation efficiently. This streamlined approach not only saves time but also ensures compliance and organization throughout the trial process.

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.

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.

oomnia is a unified clinical trial system designed to simplify clinical trials regardless of phase or therapeutic area. It brings together EDC, RTSM, CTMS, eTMF, ePRO, and eCOA into one real-time, interoperable SaaS system, ensuring faster execution, full compliance, and clean data across your entire trial.

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.

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.