Alternatives to Protocol Manager (CTMS)

Castor offers an intuitive and comprehensive platform for managing clinical trial data, focusing on electronic data capture (EDC), eConsent, and patient-reported outcomes (ePRO). The platform is optimized for decentralized trials, providing seamless tools for remote patient engagement and data collection. With real-time reporting, Castor helps researchers track trial progress and make data-driven decisions. The solution ensures compliance with industry regulations such as HIPAA, GDPR, and 21 CFR Part 11, making it ideal for life sciences organizations looking to enhance trial efficiency while maintaining high data integrity.

Medrio's Electronic Data Capture (EDC) platform and complimenting eClinical solutions such as ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have been trusted by major pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic companies since 2005. We are known for our easy-to-use solutions, delivering speed and simplicity to clinical trials of all phases, sizes, and complexities. Medrio users can build their databases in an average of 2.8 weeks with no programming required, make mid-study changes with just a few clicks of a mouse, and much more. From bolt-on capabilities to full-service offerings, Medrio offers flexible, modular solutions that give our customers exactly what they need – and none of what they don’t. Our innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.

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.

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.

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

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

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.

Full cycle product for Research and Development Teams in the Pharmaceutical Industry. The product includes Electronic Trial Master File and Trial Management. It also has Electronic Document Management with eSignature support. This product is suitable for areas regulated by 21CFR Part 11 requirements.

Clinion RTSM makes it easy to manage clinical trial supply and patient randomization by using Interactive Response Technologies (IWRS). The Inventory module, which integrates with the Clinion RTSM Software's Randomization module, allows you to implement simple or complex randomization strategies according to protocol specifications. Clinion has one of the best integrated EDC/RTSM platforms available in the industry. Site users can perform Randomization, drug allotment, returns, and re-allotment without having to log in to two systems or worry too much about reconciliation Our predictable and affordable pricing model allows you to lower the cost of RTSM ownership while not sacrificing quality or functionality. You can gain more by integrating EDC and RTSM modules

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

Replior is a pioneering company specializing in software solutions for clinical trials, featuring an integrated platform that encompasses EDC, eConsent, ePRO, and Virtual Visits to enhance trial execution. Our comprehensive system, known as Trial Online, facilitates the seamless collection and management of data from investigators, participants, and wearable devices in an efficient manner. It is designed to accommodate decentralized clinical trials (DCT), allowing for flexibility with site visits, remote interactions, or a combination of both. Our journey commenced two decades ago when we were approached to create an online CRF service for a major pharmaceutical firm, marking our transition from an IT operations provider to a dedicated software developer for clinical data collection. Over the years, we have expanded our offerings to include a complete suite of data collection services, while our IT operations are expertly managed by our highly qualified sister company, Complior. As we continue to innovate, our commitment to enhancing clinical trial processes remains at the forefront of our mission.

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.

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

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.

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.

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.

Cytel stands out as a prominent global innovator in software for clinical trial design, biometrics, and advanced analytics, focusing on maximizing the efficiency of clinical trials while aiding pharmaceutical companies in harnessing the full scope of both clinical and real-world data. Established in 1987 by renowned statisticians Cyrus Mehta and Nitin Patel, Cytel has consistently been a leader in adaptive clinical trial technology and the field of biostatistics. Its software solutions, notably the East Horizon platform, facilitate accurate trial design and simulation, employing adaptive and Bayesian methodologies to enhance protocols and expedite the drug development process. The East Horizon platform serves as a comprehensive integration of Cytel's reliable software offerings, featuring R integration that significantly improves trial design functions. Furthermore, Cytel provides the Xact software suite, which is an all-encompassing toolkit designed for statistical analysis of small datasets, including those with sparse and missing data. By continuously innovating and expanding its product offerings, Cytel remains committed to providing cutting-edge solutions that meet the evolving needs of clinical research.

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

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.

At ePharmaSolutions, we are pioneering innovative approaches. While we don't classify ourselves as a high-tech firm, our foundation is built on ideas that are deeply rooted in technology yet not confined by it. We enhance the drug development landscape by offering solutions that streamline the processes of identifying, activating, training, and managing clinical trial sites. By viewing traditional challenges through a new lens, we provide technology-driven solutions designed to simplify the complexities of clinical trial management. ePharmaSolutions (ePS) stands out as a premier provider of e-clinical solutions that transform the methods of selecting, training, activating, and overseeing clinical trial sites. By infusing fresh perspectives into longstanding issues, we create innovative, technology-facilitated solutions that enable sponsors, contract research organizations, and investigator sites to effectively navigate and simplify the intricacies of clinical trial management. Our commitment to redefining these processes ensures that we remain at the forefront of the industry, continually adapting to meet evolving needs.

DrugDev Spark™ stands out as the first all-encompassing unified clinical operations suite globally. Delve into our offerings below to discover the reasons behind the trust placed in DrugDev technology by numerous sponsors, including 9 out of the top 10, and CROs, with 4 of the top 5 relying on our services. This groundbreaking platform merges cutting-edge technology with expert services, demonstrating its value across thousands of clinical trials. Our solutions, meticulously tested and refined by sponsors, CROs, and sites of various scales in over 60 countries, encompass every aspect from planning to closeout. Our extensive experience has enabled us to incorporate best practices into every feature of our system. Consequently, it’s no surprise that leading organizations, including 9 of the top 10 pharmaceuticals and 4 of the top 5 CROs, trust DrugDev technology. The collaboration fostered by our solutions is transforming the landscape of clinical trials, facilitating more efficient and effective processes for sponsors and CROs alike. Many of the world’s foremost sponsors and CROs are leveraging DrugDev solutions to revolutionize their approach to conducting clinical trials through enhanced teamwork and innovation.

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.

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.

Signant Health operates as a worldwide leader in evidence generation, striving to transform the landscape of clinical trials by connecting with patients in their environments and rethinking the route to validation. Their extensive range of clinical technology solutions includes electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and a cohesive eClinical platform. Additionally, they offer patient engagement solutions featuring a user-friendly app, eConsent for informed consent processes, and telemedicine functionalities. Furthermore, Signant Health delivers clinical data and analytics services, which include COA data analysis as well as the aggregation and interpretation of data. With a rich history spanning over three decades, they have played an instrumental role in supporting numerous trials and have been pivotal in hundreds of drug approvals, establishing themselves as a reliable ally for sponsors and CROs eager to provide high-quality data for informed trial decisions and regulatory submissions. Their commitment to innovation continues to shape the future of clinical research.

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.

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.

As a provider specializing in Data Management, we deliver comprehensive services that include both data management and the planning and development of statistical analyses alongside suitable CRF design. We ensure that all necessary documentation complies with FDA standards and other relevant regulations. Our previous experiences indicate that investing more time in the planning stage significantly enhances the overall efficiency and speed of the trial's final phases. Our databases are meticulously created by seasoned data managers who possess extensive knowledge of various eCRFs and understand the essential aspects of electronic data capture system design and data collection. This expertise enables us to construct the eCRF in a remarkably short timeframe. Additionally, the validation and testing of the eCRF are critical components of our design process, handled by separate personnel to guarantee a thoroughly detailed and functional eCRF. By prioritizing these elements, we can ensure the highest quality outcomes for our clients.

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

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.

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.

Our platform delivers extensive support tailored to the needs of your clinical trial by leveraging advanced cloud-based technology. Clinibase empowers your organization to achieve remarkable improvements in both efficiency and productivity. Rather than employing a generic plug-and-play method with our Clinical Trial Management System, we take the stance that each organization possesses distinctive systems and workflows. Consequently, Clinibase can be entirely customized to meet the specific clinical trial needs and requirements of your organization. In addition, we implement surveys to identify issues, highlight areas for enhancement, and automate each facet of your daily clinical trial operations. With our social integration tools, you can swiftly identify and recruit eligible participants, expediting the process significantly. Moreover, we prioritize participant engagement through seamless communication pathways that promote high retention rates and foster positive experiences for those involved. By ensuring that data is both accurately recorded and securely stored, you can enhance the integrity of your trials. Our commitment to customization and efficiency establishes Clinibase as a vital partner in your clinical research endeavors.

Clin'form is an adaptable and powerful electronic Clinical Outcome Assessment (eCOA) platform that aims to simplify clinical trials for both patients and research sites, improve data integrity, and speed up processes for research teams. Its versatility allows it to be used across various protocols and demographics, making it suitable for any type of questionnaire—including Patient-Reported Outcomes (PRO), Observer-Reported Outcomes (ObsRO), Clinician-Reported Outcomes (ClinRO), and diaries—while catering to individuals of all ages, from children to the elderly. The platform is designed to handle diverse population sizes, effectively managing studies that involve anywhere from a small group to over 10,000 participants spread across multiple regions worldwide. Clin'form integrates smoothly with other clinical systems to provide an efficient workflow, supporting various data collection methods such as dedicated tablets or smartphones, the patient's personal device, web access on any browser, and in-person interviews. Noteworthy features include an integrated tele-visit option to accommodate unexpected changes and patient engagement tools that promote high levels of compliance. Additionally, Clin'form's user-friendly interface ensures that both researchers and participants can easily navigate the platform, making the clinical trial experience more streamlined and effective.

Experience an unrestricted trial period with no limits on the number of participants, clinical locations, treatment groups, or stratification factors, all for a single payment. Benefit from comprehensive assistance for double-blind studies, encompassing kit oversight, replacements, and emergency unblinding procedures. Randomize.net offers advanced randomization techniques such as permuted blocked stratification, minimization, and straightforward randomization methods. Tailor your randomization applications to include the specific options and functionalities you desire. With the Web Service API from Randomize.net, seamless integration of randomization into your own application is achievable. Complete support is available for both subject randomization and reporting needs. This highly secure online randomization service is designed specifically for clinical trials, ensuring reliability and integrity. Additionally, the platform enables researchers to focus on their core objectives while managing the complexities of study design efficiently.

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.

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.

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

Clinicubes CTMS is a robust and effective clinical trial management system designed specifically for hospitals, site management organizations, and smaller contract research organizations, emphasizing finance tracking, budgeting, and comprehensive reporting. This platform includes a variety of valuable features that facilitate the efficient management and execution of all components of clinical trials. By centralizing the management of the trial database, it ensures access to the most current information, thereby enhancing overall productivity. The system allows for the aggregation, organization, and restructuring of databases related to physicians and healthcare service institutions. Additionally, it enables the collection, evaluation, and analysis of data from numerous studies across various locations, consolidating findings into a single report. It also offers reporting capabilities that measure trial execution against established criteria and objectives. Moreover, the system provides interactive dashboards for communicating study performance metrics and other operational insights. Ultimately, this advanced CTMS enhances decision-making processes and optimizes trial outcomes.

Our leading solution for managing patient randomization and trial supplies is available in various formats, making it the most adaptable and customizable Interactive Response Technology on the market. Whether you're conducting Phase I or Phase IV trials, and regardless of whether your study design is straightforward or involves complex adaptive methodologies, IXRS®3 is equipped to handle any combination of study goals. Additionally, you will benefit from a dedicated team of biostatisticians and integration specialists who are available around the clock to provide support. The functions intended for site users streamline processes that are typically vulnerable to human mistakes, allowing them to correct data independently without needing to contact a Help Desk or worry about compliance issues. Instead of sifting through numerous pages of specifications and legal jargon, users can access clear visual tools that enhance understanding. Furthermore, you can monitor and respond to each development stage of the software build, which helps to prevent unexpected issues during delivery, ensuring a smoother trial experience. This comprehensive approach not only facilitates efficiency but also empowers users with greater control over their trial processes.

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.

AI-driven analysis of medical imagery is complemented by sophisticated automation of clinical data processes. Offered as a web-based SaaS or an on-premise solution, UNITY has garnered global trust from leading medical technology firms and healthcare institutions for its ability to gather comprehensive, consistent, and compliant data. Its integrated modules for Patient-Reported Outcome Measures (PROM), electronic Case Report Forms (eCRF), and medical image analysis optimize essential data collection tasks, thereby facilitating quicker and more cost-effective clinical trials. RAYLYTIC's Imaging Core Lab brings decades of expertise in the precise, automated, and independent assessment of musculoskeletal structures and device efficacy in areas such as the spine, hip, and knee, providing clients with unmatched analytical and operational assistance. This advanced capability ensures that medical professionals can rely on high-quality data to inform their decision-making processes, ultimately improving patient outcomes.

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.

In recent years, the Life Sciences sector has incurred nearly $15 billion in fines and settlements related to compliance, underscoring the importance for firms to follow best practices in pharmaceuticals, medical devices, and biotechnology. Additionally, the way clinical trials are managed can greatly influence the timeline, scope, and financial resources allocated for the development of drugs or medical devices. Utilizing OpenText™ Clinical Trial Quality Management System (ctQMS) allows organizations to maintain compliance, lower record management expenses, and foster collaboration to implement best practices throughout the entire clinical trial lifecycle. This strategic approach not only enhances operational efficiency but also contributes to the overall success of product development initiatives.

The TCS ADD platform significantly enhances the speed at which pharmaceutical companies can bring products to market by streamlining the entire clinical research and development process, ultimately leading to more agile and secure clinical trials. By fostering digital ecosystems and simplifying the intricacies of data management, TCS ADD facilitates quicker access to innovative and effective medications for patients. This platform utilizes the TCS Decision FabricTM, an advanced cognitive artificial intelligence engine, alongside smart analytics and the Internet of Things, delivering exceptional business advantages to the pharmaceutical sector. It serves as a comprehensive, metadata-driven solution designed to uphold industry standards and sponsor requirements in clinical trials. Furthermore, this data science-oriented platform employs artificial intelligence and machine learning technologies to expedite decision-making, accelerate study initiation, and implement targeted interventions. By digitizing the entire supply chain management of clinical trials while prioritizing patient safety, this solution not only improves overall effectiveness but also enhances the patient experience throughout the trial process. Ultimately, TCS ADD represents a transformative approach to clinical trial management that aligns with the evolving needs of healthcare.

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.

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.

Studypages serves as an all-in-one clinical trial management software aimed at creating a cohesive experience for participants while optimizing clinical operations. It includes a variety of tools that support participant involvement, site administration, sponsor supervision, effective communication, teamwork, and automation of workflows. By merging these features within a singular platform, Studypages significantly boosts the productivity and effectiveness of clinical research, thereby expediting the advancement of medical breakthroughs. Additionally, this integration helps to ensure that all stakeholders are aligned and informed throughout the research process.

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.

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.

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

The innovative IWRS facilitates a streamlined and organized drug distribution across various investigation sites, significantly minimizing drug wastage while also adeptly managing intricate randomization processes for both single-arm and extensive multi-arm, multi-center studies. Additionally, the SyMetric Platform's Dynamic Adaptive Randomization feature prevents covariate imbalances among participants, ensuring equitable Treatment Assignment regardless of the sample sizes involved. With the patient management capabilities on the SyMetric Platform, users can efficiently handle Subject Screening and Enrollment, manage Visits, dispense and receive Investigational Product (IP), execute Unblinding, and oversee Withdrawals and Completion processes. Moreover, the robust IP supply management tools embedded in the SyMetric Platform empower drug supply coordinators to maintain stringent control over the supplies dispatched to sites, allowing them to modify supply strategies based on the current treatment arms and updated ratios. This comprehensive approach not only enhances operational efficiency but also strengthens the integrity of clinical trial outcomes.