Alternatives to SMART-TRIAL

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.

In a matter of hours, you can create an eCRF that is just as easy to use and as simple as a paper one. This will help you avoid the most common problems in data collection for Pre-authorisation and post-authorisation studies. When creating an eCRF, make sure you have an EDC that is flexible. This will allow you to adapt to any type of study. The EDC includes a number of monitoring and management tools that will help you save a lot of time and effort in managing and monitoring the study. You should use a valid system that gives trust to the sponsor and allows for the collection of high quality data. Do not wait until the analysis phase to find errors in the data. Otherwise, you will have to chase down investigators to correct them. Avoid making the process of creating an eCRF long and complicated.

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

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

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.

Complex eClinical Solutions for EDC/ERT/eCOA significantly speeds up the start and completion of clinical trials (up to 5 days), reduces costs (up to 80% for monitoring), and increases capitalization and attractiveness (recognized by 89% customers). 96% of data science specialists say it increases the knowledge and advancements of Data Management and Data Science professionals. 94% of investigators love interfaces' usability. Strong internal competence in Data Management 365 is an important part of the Data Management 365 policy. This allows us to not only better understand the challenges faced by Data Managers and improve the MainEDC™, but also to transfer technology and best practices to our clients.

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.

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.

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

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.

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.

TrialPoint™ electronic data capture (EDC) is highly adaptable and user-friendly, earning the approval of coordinators everywhere. Our skilled data managers specialize in transforming clinical protocols into accessible metadata dictionaries, ensuring that TrialPoint™ is tailored to your needs rather than hindering your processes. The platform is capable of accommodating any randomization string, media uploads, or coding dictionaries, and it has the functionality to obscure treatment assignments from users. To enhance timely data collection, the system proactively determines visit windows and dispatches alerts and reminders, helping to keep the entire team aligned and on track. In the current landscape, incorporating patient-reported health outcomes and quality of life questionnaires is common in clinical trials, often leading to protocol adherence challenges. Explore TrialPoint's electronic patient-reported outcomes (ePRO) module, which can be customized to accommodate any quality of life questionnaire or patient diary, providing a seamless experience for participants. Ultimately, this flexibility not only facilitates compliance but also enhances the overall quality of the data collected in clinical trials.

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

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

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.

Jeeva's patent-pending modular system is built on the most powerful cloud platform. One login from any browser-enabled device can be used to remotely screen patients, educate, enroll, send SMS, email and generate evidence including electronic patient-reported outcomes. They are tired of waiting for patient recruitment and retention to happen. It is crucial to provide sufficient evidence of safety and efficacy for investigational new medicines in order to receive regulatory agency approval. Jeeva is a great tool for saving time and money for patients, biopharma sponsors, and long-term follow up studies for gene therapy.

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.

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.

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.

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.

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

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.

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.

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.

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.

Koneksa stands out as a prominent digital biomarker firm catering to the pharmaceutical and biotechnology sectors, focusing on the creation, testing, and validation of digital biomarkers that assist clients in assessing how treatments affect patients. Established in 2013, Koneksa delivers comprehensive remote clinical trial support by integrating digital health technologies, therapeutic knowledge, and swift, user-friendly remote data gathering to enhance understanding of patient health outcomes. Their innovative and validated data algorithms are designed for immediate use in treatment development initiatives, facilitating the detection of signals more rapidly than conventional methods. The company's cloud-based Software as a Service (SaaS) platform enables real-time integration of multiple endpoints, providing instant access to data and supporting informed, cost-effective decision-making early in the trial process. Additionally, this platform’s capability to gather extensive remote data at higher frequencies presents opportunities for obtaining ecologically valid measures, which can lead to a reduction in sample size while maintaining the integrity of the research. By continuously evolving their tools and methodologies, Koneksa aims to redefine how clinical trials are conducted in the modern age.

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

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.

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.

uMotif is an innovative platform for eCOA/ePRO and eConsent, aimed at enhancing both clinical and real-world research efforts. Created with input from patients, this platform offers unmatched engagement, significantly improving the speed, quality, and precision of data collection. Through the integration of uMotif's eCOA/ePRO system with real-time glucose monitoring, the platform achieved remarkable compliance rates during a comprehensive diabetes study across Europe. In another instance, an immunology trial benefited from the patient-focused eCOA/ePRO solution, enabling the sponsor to fulfill data requirements a full six months ahead of schedule. Additionally, in a CNS study mandated by the FDA, participants utilized their personal devices to provide submission-ready ePRO data, showcasing the platform's versatility. uMotif's commitment to a patient-first design philosophy emphasizes a deep understanding of the patient experience and the factors influencing their behavior. This expertise not only ensures the development of software that addresses patient needs effectively but also results in extraordinarily high engagement levels for study sponsors, fostering a win-win environment for both parties.

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.

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

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.

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 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.

Catchtrial is an online electronic solution that allows you to manage CRFs, images and other data with efficiency and speed. Catchtrial is simple, secure, and affordable. It has been used by both large and small businesses to manage international trials. Catchtrial replaces the paper-based process and allows for cost savings. To collect paper CRF, there will not be any need to visit sites. You can also upload images and capture them, so you don't need to ship CD roms. The study progress can be accessed from sponsors' offices, giving them full control. Catchtrial is unique in that it offers flexible personalizations and functionalities that make trial management easier than other eCRF options.

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.

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.

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.

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.

Phoenix CTMS is a comprehensive, web-based clinical research platform that integrates Patient Recruitment System (PRS), Clinical Trial Management System (CTMS), and Clinical Data Management System (CDMS) capabilities into a single modular solution. The platform is designed to address the full spectrum of operational and regulatory demands faced by academic researchers, CROs, and hospitals running clinical trials at any phase. Phoenix CTMS provides a secure, private registry for sensitive patient data, ensuring compliance with EU-GDPR and other data privacy regulations. It supports a highly flexible electronic data capture (EDC) system with unlimited JavaScript form scripting for both server and browser, making it ideal for managing complex and large electronic case report forms (eCRFs). Users can conduct parallel trials while efficiently organizing site staff and resources through an intuitive interface. Unlike many commercial EDC packages, Phoenix CTMS is an open source project under LGPL 2.1, developed in collaboration with clinical trial sites at the Medical University of Graz. It is designed as a turnkey system that is operational out-of-the-box, eliminating the need for integrating multiple disparate tools. The platform is particularly suitable for users seeking a secure, private, and customizable clinical trial management solution.

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.

Suvoda is a worldwide leader in clinical trial technology, focusing on intricate, life-preserving studies in fields like oncology, central nervous system conditions, and rare diseases. Established in 2013, the company provides a comprehensive platform featuring Interactive Response Technology (IRT), electronic Consent (eConsent), electronic Clinical Outcome Assessments (eCOA), and ePatient solutions, all aimed at streamlining essential patient interactions. Their innovative software design guarantees a fluid user experience, enabling accurate randomization, efficient drug supply management, and immediate data collection. With a strong commitment to improving patient understanding and alleviating the demands on trial sites, Suvoda's offerings are designed to evolve alongside the increasing complexities of clinical trials. Based near Philadelphia, with additional offices across Europe and Asia, Suvoda has successfully supported over 1,500 trials in more than 85 countries, showcasing their global reach and expertise in the field. Their dedication to innovation and excellence positions them as a vital partner in the advancement of clinical research.

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.

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.