Alternatives to CTMS Master

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

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.

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.

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.

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

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.

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

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.

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.

Effectively monitor clinical trials from start to finish with Ennov’s comprehensive Clinical Trial Management software. Each year, clinical trial sponsors search for new ways to improve the efficiency and reduce the costs associated with running their trials. Investigational site efficiency and productivity can be improved by centralizing information, actively monitoring progress, automating schedules, managing finances, and providing accurate reporting and metrics. With the Ennov CTMS, trial sponsors and CROs are able to actively address all aspects of trial management from a single platform: investigator sites, patients, SAEs, deviations, inclusions, visit reports, phone contacts, investigational product management, trial facilities, and finances. Study managers can plan and track their trials in real time to make better decisions faster. With the Ennov CTMS dashboard functionality, study personnel get on-demand analytics to improve quality, control risk, and reduce costs.

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

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

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.

Science 37 is a pioneering clinical research organization that focuses on decentralized clinical trials through its innovative Metasite model, which eliminates the need for physical proximity, allowing patients to engage in studies from virtually anywhere. This method significantly broadens accessibility, reaching over 90% of individuals who might be excluded from conventional site-based research, and harnesses the recruiting capabilities equivalent to 20 sites in one location, thereby offering patients the flexibility they desire. The Metasite operates on a proprietary platform that not only streamlines study orchestration but also facilitates the workflow for both patients and research staff, all while efficiently capturing study data without manual reentry. By centralizing personnel, processes, and technologies, this approach guarantees built-in protocol compliance, which leads to enhanced compliance rates and the collection of high-quality data. Science 37's dedicated in-house medical teams, telemedicine investigators, and mobile nursing professionals are well-versed in the conduct of remote trials spanning various therapeutic areas, thus ensuring comprehensive outreach. This commitment to innovative trial methodologies positions Science 37 at the forefront of transforming the landscape of clinical research.

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

Lindus Health is transforming the landscape of clinical trials by providing an all-encompassing solution that yields quicker and more dependable outcomes. Our holistic methodology combines full-service CRO functions, operational site management, and cutting-edge technology, enhancing every facet of your study from initial design to final data delivery. Utilizing our nimble in-house technology, we accelerate the setup of sites and the recruitment of patients, tapping into a vast pool of over 30 million electronic health records to speed up enrollment. Our pricing model, which operates on fixed milestones and pay-on-results, aligns incentives effectively, removing the risk of unforeseen expenses and delays. With an impressive average satisfaction rating of 9.7 out of 10, our dedicated and experienced clinical operations team is committed to achieving excellence at every stage. Lindus Health has quickly broadened its global footprint, successfully conducting more than 91 trials across diverse therapeutic areas, such as metabolic health, women's health, diagnostics, and medical devices, all while maintaining a focus on innovation and quality in clinical research. This relentless pursuit of efficiency and reliability makes Lindus Health a leader in the industry.

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.

We create innovative solutions that enhance and strengthen the clinical trial ecosystem. Our platform for Enrollment Performance Management is favored by research sites and relied upon by sponsors. It is utilized by 2,000 research sites in 26 countries and is endorsed by half of the world's top-20 biopharma companies. This enables sites to reduce time spent on repetitive and manual activities, facilitating a smoother patient progression. By minimizing redundant efforts, there are fewer logs, phone calls, and emails required from both sites and sponsors. Sponsors can proactively improve enrollment with immediate access to advanced pre-screening and enrollment metrics. Our remarkably straightforward patient recruitment and enrollment solution is trusted by over 1,800 sites worldwide. Gain access to impactful recruitment and enrollment insights, ensuring clinical trials are conducted faster and with greater predictability. By eliminating unnecessary tasks, sites can refocus their efforts on what truly matters: providing assistance to patients. Effortlessly manage recruitment across all trials, sponsors, or CROs with the ability to input information once and have it directed where it is needed most. This innovative approach not only streamlines the process but also enhances collaboration among all stakeholders involved in clinical trials.

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

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.

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.

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.

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.

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

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.

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.

ClinOne serves as a comprehensive platform that enhances connectivity and empowerment for participants, caregivers, and clinical trial sites by providing essential tools for trial awareness, consent management, and fostering participant engagement and retention, all supported by robust data analytics and standardized interoperability. Among its many features, Site Hub acts as a centralized resource for trial sites to access vital information, including criteria for participant inclusion and exclusion, site resources, and a streamlined systems landing page equipped with single sign-on capabilities and community engagement options. The Connect module further enriches the experience with features like Sponsor & Monitor Hub, trial awareness initiatives, a healthcare provider community, site selection processes, and data addressing diversity, equity, and inclusion. Meanwhile, the Inform module focuses on facilitating consent management and education through eConsent with eSignature options, as well as offering data insights, tele-visit functionalities, and avenues for community collaboration. Additionally, the Empower module enhances the overall trial experience with services such as transportation management, monitoring medication adherence, and providing a dedicated portal for care partners and caregivers, ensuring a holistic approach to participant support throughout the clinical trial journey.

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.

Access your study's data instantly via a unified dashboard that keeps you informed about key milestones, overall study progress, and various Key Risk Indicators (KRIs). By proactively identifying and resolving issues as they arise, you can significantly reduce research risks and enhance trial performance. Compare your trial's performance with Lokavant's exclusive data to make the most of your resources and lessen the burden on your study team. Source trial data is seamlessly integrated and standardized in real-time alongside Lokavant's proprietary data and that of its partners. This results in a streamlined, self-service overview of study performance, complete with automated reporting and benchmarking features. Additionally, daily re-forecasting of enrollment and site performance allows for effective comparisons to historical data, yielding valuable insights that can drive better decision-making. This holistic approach ensures that you stay ahead of potential challenges, fostering a more efficient research environment.

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

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.

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.

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.

VIPER streamlines the process of screening by automating remote patient identification right at the diagnosis stage and ensuring qualified enrollment. By leveraging artificial intelligence, VIPER efficiently matches patients to precision trials during a critical enrollment period by utilizing lab-agnostic genomic data, electronic medical records (EMR), and pathology information tailored to both the patient and the research requirements. The system employs a specialized matching engine that searches for the most suitable clinical trials corresponding to a patient's specific diagnosis at the moment they receive it. Additionally, through seamless workflow integration, VIPER provides real-time alerts regarding a patient’s eligibility for available trials, ensuring the entire care team is informed during this narrow enrollment timeframe. Furthermore, VIPER features interactive dashboards that offer extensive data mining capabilities, allowing for the aggregation of site and study-level patient data to effectively meet study key performance indicators (KPIs). This comprehensive approach not only enhances trial recruitment efficiency but also supports researchers in achieving their goals more effectively.

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

Clinpal stands out as the premier comprehensive clinical research platform specifically designed for virtual, hybrid, and direct-to-patient studies. Patients can access the platform from any location using various devices, ensuring convenience and accessibility. Research teams can harness robust data and analytics throughout the entire duration of the trial, while sites benefit from having all necessary functionalities consolidated into one user-friendly system, thus alleviating their workload. With Clinpal Build, users can utilize an intuitive point-and-click interface that allows Contract Research Organizations (CROs) and others to swiftly and effortlessly define data, forms, and workflows. The platform's Single Platform feature offers complete support for clinical trials, encompassing everything from patient recruitment and data capture to long-term follow-up, with data readily available as needed. Clinpal’s cutting-edge technology is designed to accommodate multiple formats, providing a unified online configuration; by setting it up once, it seamlessly operates for users on browsers, mobile devices, or applications. This innovative approach ensures that researchers and participants alike can engage with clinical trials in a streamlined and efficient manner.

Clindata Cloud gathers pre-clinical, clinical, and Risk Metric data from various sources and provides the clinical operations teams with data sets that are ready for submission, along with analytics and alerts for risk-based monitoring. It integrates and harmonizes study data from different origins into a unified data model, ensuring that the incoming data is validated for factors such as completeness, accuracy, integrity, and consistency while also raising alerts for any anomalies or risk indicators. Data is standardized according to CDISC data standards to reduce noise and facilitate the creation of ready-to-submit data sets in real-time, allowing for ongoing validation and analysis. Additionally, it produces real-time analytics based on the standardized data, ensuring timely insights for clinical decision-making. This comprehensive approach enhances the efficiency and reliability of clinical operations.

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.

Ready by ArcheMedX for Pharma and Biotech Trusts to better equip their trial team, improve decision-making, and reduce study delays By understanding which sites and teams are best equipped to conduct the study, you can avoid the most common causes of study delays. Reduce the time and cost of resolving problems, especially early in a trial. You can be confident that the sites you choose truly understand your patient eligibility requirements. You'll feel more confident that they will be better equipped to help you enroll eligible patients faster, meet enrollment targets, and avoid screen failures. You can be confident that the trial team is fully conversant with the protocol, down to the individual and study objectives. You can predict where there are risks so that you can avoid them and have fewer deviations overall.

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

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.

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

Historically, clinical trials and medical research operated separately from the routine care provided in local healthcare facilities and by individual doctors. Many physicians remained unaware of ongoing research initiatives, leaving patients largely uninformed about studies that could enhance their treatment outcomes or health. Elligo has transformed this landscape by facilitating unprecedented participation in clinical research through access to a vast network of over 150 million patients and their comprehensive data, enabling doctors to present research opportunities to patients who might not otherwise encounter them. Traditional methods of recruiting participants often face challenges, such as the need for patients to travel to specific research sites, which can limit involvement. Moreover, studies indicate that patients are more inclined to participate in research when it is associated with their trusted healthcare provider, underscoring the importance of integrating clinical research into familiar medical environments. This approach not only bridges the gap between research and patient care but also empowers individuals to take part in potentially life-changing medical advancements.

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.

Phoenix CTMS is an innovative web application that integrates the functionalities of database software essential for clinical research into a cohesive modular system. After extensive collaboration with trial sites at the Medical University of Graz, Phoenix CTMS is now available to the public under the LGPL 2.1 license. This exceptional suite of features is designed to meet all operational and regulatory needs of the clinical front end in academic research, as well as at CROs and hospitals that manage clinical studies across all phases. If you're looking for a CDMS that offers unlimited support for JavaScript form scripting on both server and client sides, this system is ideal. It efficiently handles large electronic case report forms (eCRFs) and serves as a robust open-source alternative for those needing to utilize eCRFs. With the ability to formulate complex ad-hoc database queries for identifying suitable subject candidates through set operations, it also facilitates the management of multiple trials simultaneously, ensuring effective organization of site staff and resources. Furthermore, the software aids in implementing various processes in accordance with ICH GCP guidelines, making it a comprehensive solution for clinical trial management.