Alternatives to eReconciliation

Ethical eAdjudication represents a cutting-edge software solution for endpoint adjudication and e-clinical needs. This cloud-based service is crafted specifically for study leaders, quality assurance personnel, and committee members, providing an exceptionally user-friendly experience. It simplifies the management of event databases, facilitates committee evaluations, and organizes meetings focused on resolving disagreements and achieving consensus within a GxP compliant framework. By utilizing Ethical eAdjudication, users can perform independent reviews and adjudication processes effectively, ensuring timely results while maintaining rigorous quality control standards. This innovative platform not only streamlines operations but also enhances collaborative decision-making among stakeholders.

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.

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

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.

IVR Clinical Concepts is a company that focuses on offering technology for virtual clinical trials and solutions for patient engagement. Their products feature electronic patient-reported outcomes and patient diaries, which are designed to enhance data quality by minimizing errors, thereby shortening timelines and reducing overall costs. Furthermore, they provide comprehensive patient recruitment and outreach services that emphasize outreach, pre-screening, and the collection of real-time data. The solutions for subject screening, registration, and randomization are characterized as modular, tailored, adaptable, and customizable. In addition to these services, IVRCC also delivers clinical trial material management solutions aimed at lightening the workload while ensuring greater control, along with eClinical integration services that work to unify data seamlessly. Their chart review services offer insights based on real-world data and clinical experiences. By prioritizing custom, modular, and adaptable solutions, IVRCC strives to enhance the patient experience and maximize the success rates of clinical trials. This commitment to innovation positions IVRCC as a leader in the industry, dedicated to improving the efficacy of clinical research.

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

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

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.

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.

DFnet is a company specializing in healthcare technology that delivers eClinical solutions such as electronic data capture, eSource, and comprehensive data management services. We enhance clinical trials globally by providing increased flexibility, improved data quality, and enhanced efficiency. Our platform allows for data collection from various sources, including paper CRFs, EDC, and other electronic systems, along with online and offline tablet entries and ePRO. You can either set up our system on your premises or utilize our secure cloud hosting options. Our advanced optical recognition technology accelerates SDV and RBM processes, significantly reducing the time required for manual data entry. Designed for optimal adaptability in multi-center studies, our web-based data capture system makes data from any source readily accessible in a centralized real-time platform. This capability ensures that researchers can make informed decisions quickly and efficiently, ultimately improving the overall conduct of clinical trials.

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.

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.

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.

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.

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.

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.

Mednet is an eClinical technology company that specializes in healthcare solutions for the global life science community. Mednet's flexible, EDC-centric eClinical platform increases the efficiency of clinical research of all sizes. Mednet's comprehensive solution suite provides all the tools necessary to create and manage clinical research. It can also adapt to changing demands and requirements. Mednet has been trusted by CROs in every sector of the pharmaceutical, medical device, and biotechnology industries for almost 20 years. They provide the expertise, reliability, and innovation that they need to succeed. Mednetsolutions.com has more information.

DSG, Inc., a global leader in eClinical, offers a complete suite of innovative technology solutions as well as data management services to the global clinical research community. DSG's eClinical platform offers a competitive advantage and on-time delivery. DSG solutions have been used in thousands clinical trials across the globe using our award-winning eCaseLink™, platform and eCaseLinkDesign for enterprise licensing. The company was founded in 1992 and is proud to have been awarded the SCDM Data Driven Innovation Award.

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.

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.

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

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.

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

Streamline your clinical studies with Clinvigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us for thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The Clinvigilant eClinical suite includes: EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. Every interaction and data exchange creates Audit Trails, which provide compliant real-time data visibility across all relevant roles. Our products are modular, highly customizable, and available on the web, iPad, and Mobile App for both Android and iOS. We also support Patient's Own Device (BYOD) and interface with Devices and Wearables. Clinvigilant💊, your one-stop🌐solutions provider for clinical trials☁️ .

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.

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

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.

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

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.

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

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.

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.

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.

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.

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

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.

HumanFirst is establishing the necessary operational framework to facilitate decentralized trials and provide distributed care directly at home. Our workflow management platform equips your team with essential tools for tailored remote monitoring solutions. The timeline-driven interface supports every stage from evaluation to deployment and management. We have cataloged connected sensor technologies in Atlas, classifying physiological and behavioral metrics into over 150 distinct categories. Our expertise covers medical conditions across more than 25 therapeutic areas. Utilizing the open-access V3 Framework, we have analyzed more than 500,000 pieces of evidence to identify optimal technologies for digital endpoint measurement. By implementing remote monitoring, we aim to enhance patient outcomes significantly. You can also showcase your connected product on Atlas, contributing to an expansive network of innovations. Our commitment to open-access publications has garnered recognition in leading peer-reviewed journals, emphasizing our dedication to advancing healthcare. HumanFirst is dedicated to promoting safe, effective, and equitable healthcare practices in the home environment, ensuring that every patient receives the best care possible.

Data management is crucial to the success and efficiency of your clinical research. Despite being complex, Quanta View, an e-CRF, makes it possible to control the processing of your data. Quanta View includes elements such as monitoring, follow up of inclusions, and project management. The application will be there to help you in all aspects of your clinical research. It is accessible via the internet and responsive. It adapts to all media (tablet, laptop, etc.). Quanta view is designed for the pharmaceutical, medical device, and cosmetic industries.

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.

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.

The Datimbi Platform is exceptionally designed for scenarios that require the gathering of extensive and intricately structured data from various contributors or sources, featuring integrated quality assurance measures and the ability to oversee and manage quality and collection processes in real time, along with comprehensive reporting and analysis capabilities. Furthermore, rapid setup is a key feature of our platform. It is tailored for applications like electronic Case Report Forms (eCRFs) in Clinical Trial Management, Social Case Management, econometric event study evaluations, or virtually any data collection and processing workflow that demands efficiency. If your requirements align with these use cases, you can often achieve full deployment and operational status on the platform within just one week! Setting up roles, transitioning workflow statuses, designing complex data collection forms, defining processing rules, managing lists of values, tracking changes, and creating custom email notifications can all be accomplished through an intuitive web interface. Additionally, these functionalities can be administered by your own trained personnel or through a service provided by Datimbi, ensuring flexibility and support for your organization's needs. This combination of speed and ease of use makes the Datimbi Platform a valuable asset for any data-intensive project.

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

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.

Fusion is Axiom’s proprietary, cost-effective and easy-to-use eClinical solution. It is aimed at small to medium-sized device, pharma and biotech companies. Axiom's Fusion eClinical Suite allows you to add-on any Modules that meet your study needs. Are you running a small study? You can choose the base configuration with EDC and DM, as well as AE/SAE tracking. Are you looking for something more? To make managing your study easier, you can include powerful Modules like Inventory Tracking, RTSM, Safety Management. You can save time by electronically capturing your study data - even offline! Once you have an internet connection, your data will sync to your Fusion databases. Real-time records available for subject screening activities. Fusion Safety Database allows you to manage pharmacovigilance events.

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