Top SMART-TRIAL Alternatives

Castor is an innovative clinical trial platform designed to simplify data management through electronic data capture (EDC), eConsent, and patient-reported outcomes (ePRO). Its flexible and user-friendly interface allows researchers to collect, manage, and analyze clinical data efficiently across multiple sites and remote patients. Castor’s tools are specifically designed to support decentralized clinical trials (DCTs), enabling real-time data monitoring, remote recruitment, and seamless patient engagement. The platform ensures full regulatory compliance, including HIPAA, GDPR, and 21 CFR Part 11, and is certified for ISO standards. With more than 50,000 global users, Castor continues to improve the speed and quality of clinical trials through integrated, scalable solutions that reduce administrative burdens and accelerate research.

OpenClinica stands out as a prominent provider of software solutions for managing clinical data. Their robust tools are designed to enhance the compliance and efficiency of clinical trials. The main offerings from OpenClinica include OpenClinica Enterprise, OpenClinica Participate, and OpenClinica Randomize, which together facilitate a comprehensive approach to clinical data management. Each product addresses specific needs within the clinical research landscape, making them essential for successful trial execution. OpenClinica is an industry-leading platform that enables more efficient and effective clinical trials by providing a comprehensive range of tools for managing data, patient engagement, and recruitment. Key features include electronic data capture (EDC), patient-reported outcomes (ePRO), and fully automated eConsent, all designed to improve accuracy and streamline study workflows. The platform supports EHR-to-EDC integration, reducing manual errors and accelerating data collection. OpenClinica also offers robust reporting and data analysis tools, ensuring real-time insights into trial progress. With over 15,000 studies powered and more than three million patients involved, OpenClinica is trusted by life sciences organizations worldwide, from pharmaceutical companies to academic researchers and government bodies. Its seamless integration, user-friendly design, and comprehensive features make it an essential tool for advancing clinical research.

Since 2005, Medrio's Electronic Data Capture (EDC) platform and its complementary eClinical solutions like ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have gained the trust of leading pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic organizations. Our reputation is built on providing user-friendly solutions that enhance the efficiency and simplicity of clinical trials across all phases, sizes, and complexities. Users of Medrio can create their databases in an average of 2.8 weeks without needing any programming skills and can easily implement mid-study modifications with just a few clicks. With options ranging from add-on features to comprehensive service packages, Medrio delivers adaptable, modular solutions tailored to meet the precise needs of our clients, ensuring they receive only the services they require. Our cutting-edge software, combined with extensive training and support resources, has resulted in a remarkable 98% customer satisfaction rating, demonstrating our commitment to excellence in the clinical trial landscape. We continuously strive to innovate and improve our offerings to keep pace with the evolving needs of our users.

Within just a few hours, you can design an electronic Case Report Form (eCRF) that is as user-friendly and straightforward as its paper counterpart. This approach will significantly reduce the typical challenges encountered in data collection for both pre-authorisation and post-authorisation studies. When you set out to create an eCRF, it’s crucial to utilize an Electronic Data Capture (EDC) system that offers flexibility, enabling you to customize it for various study types. Additionally, the EDC comes equipped with several monitoring and management tools that can greatly streamline the study oversight process, saving you both time and energy. It is essential to employ a reliable system that instills confidence in the sponsor and facilitates the gathering of high-quality data. Addressing any data errors only during the analysis phase can lead to complications, as it may require you to track down investigators for corrections after the fact. Therefore, strive to keep the eCRF creation process efficient and straightforward, ensuring that it meets all necessary requirements without unnecessary complexity. By focusing on these elements, you can enhance the overall effectiveness and accuracy of your research.

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.

Electronic source documents, commonly referred to as eSource, eliminate the necessity for physical paperwork, improve workflows, and significantly reduce the likelihood of mistakes and omissions. The BREEZE eSource platform goes beyond mere visit templates and scheduling capabilities. By integrating clinical settings with regulatory and protocol requirements as well as study-specific procedures, BREEZE eSource ensures that users efficiently collect all necessary data dictated by the protocol. Moreover, BREEZE’s array of business rules guarantees that the information obtained is precise, complete, and in compliance with established standards. Our dedicated team of clinical trial experts creates customized, study-specific eSource documents that are meticulously reviewed and approved before the study begins, with ongoing assistance and modifications provided throughout the duration of the trial. The various modules work together harmoniously and are designed for seamless integration. Additionally, the Cross-Module Action Multiplier not only boosts efficiency by anticipating needs but also automates supplementary tasks triggered by user input, such as promptly updating invoicing for completed visits or procedures and recalibrating the schedule as required. This thorough approach not only streamlines the process but also significantly bolsters data integrity and enhances operational effectiveness, ultimately leading to more successful clinical trials. In a landscape where efficiency and accuracy are paramount, BREEZE eSource stands out as an indispensable tool for modern clinical research.

Science 37 is an innovative clinical research organization that specializes in decentralized clinical trials using its unique Metasite model, which removes the necessity for physical locations, enabling patients to participate in studies from nearly any location. This approach significantly increases accessibility, allowing over 90% of individuals who may typically be excluded from traditional site-based research to take part, and it boasts recruitment capabilities similar to those of 20 sites concentrated in one area, providing patients with the flexibility they seek. The Metasite leverages a proprietary platform that simplifies study management and enhances workflow for both patients and research personnel, all while ensuring efficient data capture without the need for manual reentry. By consolidating staff, processes, and technology, this model ensures built-in compliance with protocols, leading to improved adherence rates and the collection of high-quality data. Furthermore, Science 37's committed in-house medical professionals, telemedicine investigators, and mobile nursing teams possess extensive experience in managing remote trials across a wide variety of therapeutic areas, guaranteeing extensive outreach and support. This dedication to pioneering trial methodologies establishes Science 37 as a leader in reshaping the clinical research landscape, thereby opening new avenues for patient engagement and participation.

Dacima Clinical Suite stands out as a cutting-edge web-based platform that integrates electronic data capture (EDC), clinical data management software (CDMS), and clinical trial management tools into a single cohesive solution. Tailored for a variety of applications, it effectively supports clinical trials, epidemiological research, web randomization, electronic patient-reported outcomes (ePRO), surveys, and patient registries. The suite features three essential modules: the Manager (Administrator), the Designer Module, and the Data Entry Module, each playing a vital role in streamlining the research process. This comprehensive approach ensures that users have all necessary tools at their fingertips for efficient data management and analysis.

TrialKit is a versatile cloud-based solution accessible through a web interface and a dedicated mobile application, designed to facilitate comprehensive clinical trial management for organizations involved in medical devices, diagnostics, digital therapeutics, and biopharmaceuticals, regardless of their scale. With our user-friendly study builder, you can create and launch validated studies in just days instead of weeks, eliminating the need for any programming knowledge. To date, numerous users worldwide have utilized the adaptability of TrialKit to successfully launch more than 8,000 studies spanning all stages of development. This platform empowers researchers to streamline their processes and enhance the efficiency of clinical research endeavors.

TrialPoint™ electronic data capture (EDC) system stands out for its exceptional adaptability and ease of use, earning the trust of coordinators across the board. Our expert data managers are dedicated to converting clinical protocols into user-friendly metadata dictionaries, ensuring that TrialPoint™ is customized to meet your specific needs instead of complicating your workflows. The platform is designed to support any randomization string, media uploads, or coding dictionaries, and it includes features that allow for the concealment of treatment assignments from users. To promote efficient data collection, the system intelligently identifies visit windows and sends out alerts and reminders, which aids in keeping the whole team synchronized and focused. In today’s environment, integrating patient-reported health outcomes and quality of life assessments into clinical trials has become standard, often resulting in challenges with protocol adherence. Discover the ePRO module offered by TrialPoint, which can be tailored to fit any quality of life questionnaire or patient diary, ensuring a smooth experience for participants. This remarkable flexibility not only boosts compliance but also improves the overall integrity and quality of the data gathered in clinical research. By utilizing TrialPoint™, you can streamline your trial processes and enhance participant engagement significantly.

Replior stands out as an innovative company that focuses on delivering advanced software solutions tailored for clinical trials, featuring a comprehensive platform that integrates EDC, eConsent, ePRO, and Virtual Visits to optimize trial execution. Our all-encompassing system, known as Trial Online, streamlines the collection and management of data from researchers, participants, and wearable technology efficiently. It is meticulously designed to support decentralized clinical trials (DCT), providing the flexibility to accommodate site visits, remote interactions, or a blend of both. Our journey began two decades ago when we were tasked with developing an online CRF service for a prominent pharmaceutical company, which marked our evolution from an IT operations provider into a specialized software developer focused on clinical data collection. Over time, we have broadened our offerings to provide a full range of data collection services, while our IT operations are adeptly overseen by our highly skilled sister company, Complior. As we forge ahead, our unwavering commitment to innovating and improving clinical trial processes remains central to our purpose, driving us to continually enhance user experience and data integrity in the trials we support.

At ePharmaSolutions, we are at the forefront of developing groundbreaking strategies. Although we do not consider ourselves a high-tech corporation, our core is founded on concepts that are intricately linked to technology yet not limited by it. We are transforming the drug development sector by providing solutions that optimize the processes of identifying, activating, training, and managing clinical trial sites. By reinterpreting conventional challenges through a fresh perspective, we deliver technology-enhanced solutions aimed at simplifying the complexities associated with clinical trial management. ePharmaSolutions (ePS) distinguishes itself as a leading provider of e-clinical solutions that revolutionize the processes of selecting, training, activating, and managing clinical trial sites. By introducing innovative viewpoints to persistent challenges, we develop advanced, technology-driven solutions that empower sponsors, contract research organizations, and investigator sites to efficiently tackle and streamline the complexities of clinical trial management. Our dedication to transforming these processes guarantees that we stay at the cutting edge of the industry, consistently evolving to address changing demands, ultimately fostering a more efficient and effective clinical trial landscape.

Cytel is recognized as a leading global innovator in the realm of software dedicated to clinical trial design, biometrics, and sophisticated analytics, with a goal of enhancing clinical trial efficiency while empowering pharmaceutical firms to fully leverage both clinical and real-world data. Founded in 1987 by esteemed statisticians Cyrus Mehta and Nitin Patel, Cytel has maintained its position at the forefront of adaptive clinical trial technology and biostatistics. Its flagship software, the East Horizon platform, plays a crucial role in supporting accurate trial design and simulation, utilizing adaptive and Bayesian approaches to refine protocols and streamline the drug development journey. The East Horizon platform represents a holistic integration of Cytel's trusted software solutions, boasting R integration that markedly enhances trial design capabilities. Additionally, Cytel offers the Xact software suite, an extensive toolkit tailored for statistical analysis of smaller datasets, effectively addressing challenges posed by sparse and missing data. By persistently innovating and broadening its range of products, Cytel is dedicated to delivering state-of-the-art solutions that align with the dynamic demands of clinical research, ensuring that researchers have the tools necessary to improve patient outcomes. As a result, Cytel continues to shape the future of clinical trials through its unwavering commitment to excellence in software development and analytics.

We are excited to unveil the newest iteration of eTMF Connect, a solution crafted with a focus on simplicity while maintaining high standards of performance. This complete overhaul of eTMF Connect results in a quicker, more scalable, and efficient eTMF solution that is equipped to handle the evolving demands of clinical trials today and into the future. With the integration of advanced data visualization and reporting tools, Montrium has significantly enhanced the business intelligence capabilities of eTMF Connect. This new functionality provides project teams and clinical operations managers with deeper insights into TMF completeness, quality, and timeliness across all studies, allowing for improved visibility. Consequently, these upgrades will advance your TMF strategy within various clinical programs. Each clinical trial comes with its own set of challenges, and the unique intricacies and regional differences can create considerable complexity that may trouble even the most experienced TMF professionals. Therefore, it is imperative that your eTMF platform possesses the flexibility to tackle these diverse challenges effectively. Achieving this adaptability enables your organization to navigate the complexities of clinical trials with assurance and accuracy, ultimately contributing to more favorable outcomes. With these advancements, eTMF Connect positions itself as an indispensable tool for managing clinical trial documentation and ensuring regulatory compliance.

With over twenty years of experience in software development and clinical research, Arone provides an extensive suite of tools specifically tailored for the entry and management of patient data in clinical research organizations. Our ready-to-use solutions come with dedicated support to guarantee the successful implementation of your studies and projects. By utilizing a unified platform, we simplify the collection and management of patient information. Furthermore, Arone streamlines the randomization process, ensuring that treatment assignments for study participants are done fairly to reduce bias. This approach not only enables participants to efficiently manage their daily data submissions but also offers personalized support for their individual projects. Our dedication lies in improving the efficiency and accuracy of clinical research through our cutting-edge solutions, paving the way for more effective studies. With a focus on innovation, we are committed to transforming the landscape of clinical trials.

Jeeva has developed a revolutionary modular system that operates on a cutting-edge cloud platform. With just one login from any device that supports a browser, users can easily screen patients, offer education, manage enrollment, send SMS and emails, and compile evidence such as electronic patient-reported outcomes. Frustrations with slow patient recruitment and retention are common in the industry, making it imperative to gather solid evidence of safety and efficacy for new investigational medicines to secure approval from regulatory agencies. Jeeva stands out as an invaluable resource for optimizing time and financial resources for patients and biopharma sponsors, particularly in long-term follow-up studies associated with gene therapy. Its innovative approach streamlines processes, ultimately enhancing the efficiency of clinical trials and improving patient care.

Efficiently oversee every phase of clinical trials with Ennov’s all-inclusive Clinical Trial Management software. Each year, sponsors of clinical trials seek innovative strategies to enhance efficiency and minimize the expenses tied to their operations. By centralizing data, consistently tracking advancement, automating timelines, overseeing budgets, and delivering precise reporting and metrics, investigational site productivity can be significantly boosted. Ennov CTMS empowers trial sponsors and Contract Research Organizations (CROs) to manage all facets of trial operations from a unified platform, including investigator sites, participants, serious adverse events, deviations, inclusions, visit documentation, communication with trial subjects, management of investigational products, trial locations, and financial oversight. Study managers can monitor and plan their trials in real-time, enabling quicker and more informed decision-making. Additionally, the dashboard features of Ennov CTMS provide study teams with immediate access to analytics, enhancing quality, mitigating risks, and curtailing costs further. This comprehensive approach ultimately leads to a more streamlined clinical trial process, fostering greater success rates.

Discover the leading edge of eSource, CTMS, and eRegulatory software tailored for clinical trial sites with CRIO. Our premier electronic source enables you to capture source data in real-time, significantly reducing paper dependency by up to 90% and improving data quality by 80%. Take control of your operations with CRIO’s intuitive Clinical Trial Management System, which streamlines patient scheduling, financial oversight, and recruitment optimization. We proudly offer innovative electronic regulatory binders, featuring the groundbreaking first-ever electronic delegation log, all fully compliant with 21 CFR Part 11 regulations. For sponsors of clinical trials, our secure online portal allows for complete remote monitoring of your sites’ source data and regulatory documents. Join our vast network of over 500 clinical research sites globally, and benefit from our dedication to enhancing your business by simplifying your site operations. This ensures that your studies progress seamlessly, whether you are on-site or working remotely, allowing you to concentrate on what truly matters: propelling your clinical research efforts forward while ensuring efficiency and accuracy throughout the process.

Clin'form is a robust and flexible electronic Clinical Outcome Assessment (eCOA) platform designed to enhance the efficiency of clinical trials for both participants and research facilities, while also improving data accuracy and expediting processes for research teams. Its adaptability allows it to be utilized across a wide array of protocols and demographics, making it ideal for any questionnaire type, including Patient-Reported Outcomes (PRO), Observer-Reported Outcomes (ObsRO), Clinician-Reported Outcomes (ClinRO), and diaries, catering to a diverse demographic from children to seniors. The platform is engineered to accommodate varying population sizes, effectively managing studies that involve small cohorts as well as those with more than 10,000 participants across multiple global locations. Clin'form seamlessly integrates with other clinical systems to create an efficient workflow, supporting a range of data collection methods—including dedicated tablets, smartphones, patients' personal devices, web access via any browser, and in-person interviews. A standout feature is the integrated tele-visit option, which provides flexibility in response to unforeseen changes, along with patient engagement tools that are designed to foster high compliance rates. Furthermore, the intuitive interface of Clin'form ensures that both researchers and participants can navigate the platform with ease, thereby enhancing the overall clinical trial experience and effectiveness. Overall, Clin'form not only streamlines the data collection process but also places a strong emphasis on user experience, making it a valuable asset in clinical research.

eDeviation offers a thorough suite of tools designed for the evaluation and management of Protocol Deviations, simplifying the journey from software development and validation to the collection of essential documentation and the exportation of data for the Trial Master File (TMF). This innovation significantly reduces the workload on clinical teams who may encounter risks associated with poorly evaluated or neglected protocol deviations, regardless of their frequency. As part of Ethical's eClinical Software Platforms, eDeviation® improves the precision and productivity of clinical trial oversight. The software can be customized to fit the unique needs of your research team, whether assessments are made by an independent committee or internally. Its built-in forms, workflows, and export capabilities guarantee compliance with GxP standards while promoting effective study management. Moreover, the platform supports real-time online collaboration among study teams, investigators’ sites, and committee members, which accelerates decision-making and ensures that protocol deviation assessments are addressed promptly. This collaborative environment not only streamlines processes but also fosters a culture of transparency and accountability in clinical trials. Ultimately, eDeviation® plays a crucial role in enhancing the integrity and efficiency of clinical research processes, leading to improved research outcomes.

Lindus Health is revolutionizing clinical trials by offering a comprehensive solution that delivers faster and more trustworthy results. Our integrated approach merges full-service CRO capabilities, effective site management, and advanced technology to enhance every aspect of your research, from the initial design phase to the ultimate delivery of data. By leveraging our agile in-house technology, we streamline site setup and patient recruitment, utilizing a rich database of over 30 million electronic health records to expedite the enrollment process. Our transparent pricing structure, based on fixed milestones and pay-on-results, effectively aligns our goals with those of our clients, eliminating the possibility of unexpected costs and delays. With an outstanding average satisfaction rating of 9.7 out of 10, our skilled and committed clinical operations team strives for excellence at each step of the process. In a short span of time, Lindus Health has expanded its global presence, successfully managing over 91 trials in various therapeutic fields, including metabolic health, women's health, diagnostics, and medical devices, all while upholding a strong emphasis on innovation and quality in clinical research. This unwavering commitment to efficiency and reliability solidifies Lindus Health’s position as an industry leader, ensuring that we continue to push the boundaries of what is possible in clinical trials. By prioritizing both patient experience and research integrity, we aim to set new standards that will benefit the future of healthcare.

DFnet is a healthcare technology firm that focuses on providing eClinical solutions, including electronic data capture, eSource, and extensive data management services. We enhance clinical trials on a global scale by offering greater flexibility, superior data quality, and increased efficiency. Our platform facilitates data collection from diverse sources, such as paper CRFs, EDC, and other electronic systems, as well as through online and offline tablet entries and ePRO. Users have the option to implement our system on-site or take advantage of our secure cloud hosting services. Our cutting-edge optical recognition technology accelerates both SDV and RBM processes, greatly minimizing the time necessary for manual data entry. Tailored for maximum versatility in multi-center studies, our web-based data capture system ensures that information from any source is easily accessible in a centralized real-time platform. This feature empowers researchers to make swift and informed decisions, ultimately enhancing the overall execution of clinical trials and leading to better outcomes. Additionally, our commitment to innovation means we are constantly evolving our solutions to meet the changing needs of the healthcare landscape.

Koneksa has emerged as a leading digital biomarker company, serving the pharmaceutical and biotechnology industries with a focus on the development, evaluation, and validation of digital biomarkers that help clients understand the impact of treatments on patients. Founded in 2013, Koneksa offers extensive support for remote clinical trials by merging digital health innovations with therapeutic expertise and efficient, user-friendly remote data collection to improve insights into patient health outcomes. Their advanced and validated data algorithms are tailored for immediate application in treatment development, allowing for quicker identification of signals compared to traditional techniques. The company's cloud-based Software as a Service (SaaS) platform supports real-time integration of various endpoints, granting immediate data access and facilitating informed, cost-effective decisions early in the trial stages. Furthermore, the platform's ability to collect significant remote data at higher frequencies opens doors for acquiring ecologically valid measures, which can reduce the required sample size without compromising research integrity. As Koneksa continuously enhances its methodologies and tools, it seeks to transform the approach to clinical trials, ultimately leading to more efficient and patient-centered research practices. This commitment to innovation positions Koneksa at the forefront of a rapidly evolving landscape in clinical research.

Improve data management quality by capturing eSource data directly during patient encounters. This method includes integrated editing and validation features that enable users to collect high-quality information electronically, significantly reducing errors and inquiries while allowing for real-time remote monitoring. As a result, the overall duration, costs, and risks associated with studies are noticeably decreased. Approved by the FDA, this cutting-edge eSource method streamlines and modernizes the clinical trial process, effectively replacing traditional, error-prone monitoring and the manual transcription into electronic data capture (EDC) systems. Furthermore, designed with site users in mind, ez-SourceDocx enhances workflows, lightens workloads, and ensures compliance with study protocols by guiding sites through properly sequenced visit procedures, which not only guarantee the collection of all endpoint data but also promote timely quality evaluations by investigators. This all-encompassing system ultimately bolsters the efficiency and dependability of clinical trials while paving the way for innovations in data management practices. By leveraging technology in this manner, the potential for improved patient outcomes increases significantly.

AssisTek emerges as a leader in advanced clinical technology solutions specifically designed for clinical research, offering specialized software that enhances the process of collecting patient data. With a rich history spanning over 25 years, the organization has successfully supported more than 800 clinical research trials across 46 therapeutic areas, including over 500 multinational Phase I–IV trials. Their electronic Clinical Outcome Assessment (eCOA) solutions are marked by scalability, customization, and efficiency, all powered by a dependable cloud-based technology platform. Among their diverse range of products are the TEK eCOA Tablet, adaptable for any questionnaire used in clinical trials, TEK eDiary, which allows for the collection of patient-reported outcomes from home, TEK Configurator for thorough project development in clinical trials, and TEK Study Portal, which integrates eClinical tracking, training, and reporting into a single, user-friendly platform. AssisTek's pioneering systems and services have made them the go-to partner for data collection and analytics, earning the confidence of both patients and healthcare professionals. As they innovate further, AssisTek continues to focus on improving the effectiveness and precision of clinical research methodologies while exploring new avenues to advance the field. Their commitment to excellence ensures they stay at the forefront of technological advancements in clinical research.

The Medidata Clinical Cloud is an advanced platform crafted to transform the clinical trial experience for patients, sponsors, CROs, and research institutions alike. As the only all-encompassing technological solution dedicated solely to clinical research, this platform covers the entire spectrum of research from its initial stages to final outcomes. It empowers organizations within the life sciences and medical device industries to cut down on development costs, effectively manage risks, and accelerate the launch of new treatments and devices into the market. Regardless of your choice for clinical trial strategies, the advantages of the Medidata Clinical Cloud will be at your disposal. Medidata stands at the leading edge of the digital transformation in clinical research. By harnessing the capabilities of artificial intelligence, machine learning, and advanced analytics, our platform facilitates connections among researchers, study coordinators, investigators, and patients, ultimately speeding up the research process. Furthermore, it features a regulatory-compliant and patient-centric electronic informed consent solution for clinical trials, which improves the experience for everyone involved. This seamless integration of cutting-edge technology not only optimizes operational efficiency but also significantly uplifts the overall quality and integrity of clinical research endeavors. Thus, adopting the Medidata Clinical Cloud means embracing a future where clinical trials are more efficient and patient-focused than ever before.

Zelta serves as a cloud-based platform dedicated to the unified management and acquisition of clinical data, aiming to optimize and improve the processes involved in clinical trials. Its flexible modular structure is tailored to meet the specific requirements of different studies, which leads to quicker and more effective results. With features that include electronic data capture, management of clinical operations—such as randomization and tracking of trial supplies—clinical trial oversight, and electronic trial master file capabilities, Zelta provides thorough supervision of studies. Additionally, it fosters engagement among patients and providers through electronic clinical outcome assessments and e-consent options. Suitable for a range of studies across all phases, therapeutic disciplines, and international locations, Zelta is designed to offer a user-friendly experience with secure single sign-on access available from any location. Its adaptable and scalable framework permits easy customization and seamless integration with both proprietary and third-party technologies, ensuring it can meet various research requirements effectively. This makes Zelta an invaluable tool for researchers looking to streamline their clinical trial efforts.

Ofni Clinical provides a highly efficient solution for clinical data management, allowing for the rapid creation and deployment of secure databases tailored for clinical trials in accordance with regulatory requirements. This platform is equipped with an extensive suite of search and reporting capabilities, along with robust mechanisms for data validation and edit checks, ensuring that all data handled is of the highest quality. With its versatile customization features, Ofni Clinical can be implemented quickly and cost-effectively, making it an appealing option for researchers of various backgrounds. The system supports data collection from both conventional paper Case Report Forms and contemporary electronic data capture systems, offering flexibility in data sourcing. Notably, many Ofni Clinical setups can be finalized in less than a month, transforming projects from their initial stages to validated systems efficiently. If you're interested in enhancing your clinical trial processes, contact us today to learn how Ofni Clinical can facilitate a smooth transition from your current CRFs while keeping training and implementation expenses low. Moreover, its comprehensive features for edit checks and data validation assist in identifying questionable data entries, which is crucial for thorough data analysis. Users will enjoy a streamlined experience designed to effectively support their research goals, ultimately contributing to the success of their clinical trials. The combination of rapid implementation and high-quality data handling makes Ofni Clinical a valuable asset in the realm of clinical research.

IVR Clinical Concepts is a company dedicated to providing advanced technology for virtual clinical trials and enhancing patient engagement. Their offerings include electronic patient-reported outcomes and patient diaries, which aim to improve data integrity by reducing errors, ultimately leading to faster timelines and lower costs. Additionally, they offer thorough patient recruitment and outreach services that focus on engagement, pre-screening processes, and the acquisition of real-time data. The solutions for subject screening, registration, and randomization are noted for being modular, customizable, and adaptable to various needs. Alongside these capabilities, IVRCC also provides clinical trial material management solutions that help alleviate workload while ensuring better control, as well as eClinical integration services that strive for seamless data unification. Their chart review services deliver valuable insights derived from real-world data and clinical experiences. By emphasizing customized, modular, and flexible solutions, IVRCC aims to enhance the overall patient experience while increasing the success rates of clinical trials. This dedication to innovation and tailored solutions not only strengthens their offerings but also cements IVRCC's role as a prominent leader within the clinical research sector, committed to advancing the effectiveness and efficiency of clinical studies.

Mosio empowers research teams to enhance participant engagement, streamline communication, and gather data effectively through the widely used medium of text messaging. Our platform offers research teams the tools to interact more effectively with participants via mobile devices, integrating engaging elements and automated messaging features. WHO CAN BENEFIT? + Sponsors of clinical trials in the pharmaceutical and biotech sectors + Cancer treatment facilities and organizations focused on clinical research + Studies funded by the National Institutes of Health (NIH) + Agencies dedicated to public health + Professionals such as clinical trial managers, directors, project managers, principal investigators, and coordinators, along with all research personnel involved in participant communication. ADVANTAGES + Engaging medication reminders and alerts for compliance + Automation of the data collection process + Boost in participant engagement and adherence rates + SMS reminders for appointments to reduce no-show rates + Improved participant retention through automated check-ins, ensuring ongoing communication and support. Overall, Mosio serves as a vital tool for enhancing the efficiency of clinical research endeavors.

Signant Health stands as a global frontrunner in evidence generation, dedicated to revolutionizing the clinical trial landscape by engaging patients in their own settings and reimagining the path to validation. They provide a comprehensive suite of clinical technology solutions that encompasses electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and an integrated eClinical platform. Their offerings also include patient engagement tools like an intuitive app, eConsent for effective informed consent practices, and telehealth capabilities. Furthermore, Signant Health specializes in clinical data and analytics services, which involve COA data analysis along with the synthesis and interpretation of data. With over thirty years of experience, the company has been crucial in facilitating numerous clinical trials and has significantly contributed to hundreds of drug approvals, solidifying their position as a dependable partner for sponsors and CROs who aim to deliver high-quality data for informed decision-making and regulatory filing. Their unwavering dedication to innovation is continuously molding the future of clinical research, ensuring that advancements benefit both patients and the medical community at large.

Clinical Conductor CTMS is an advanced platform designed for the effective management of clinical trials. It caters to a variety of users including hospitals, research facilities, and asset management firms, as well as site networks, health systems, and contract research organizations (CROs). By utilizing this cloud-based solution, clinical trials can be executed with greater efficiency, enabling research organizations to enhance their decision-making processes. Notable features of this system encompass electronic data capture, enrollment management, document control, and recruitment oversight, among others, providing a comprehensive toolkit for trial management. Ultimately, it streamlines operations and fosters improved outcomes in clinical research endeavors.

ClinSoft™, created internally by Innovate Research, does not involve any external acquisitions or integrations. The software adheres to FDA regulations, including 21 CFR Part 11, GCP, and HIPAA standards, ensuring it is both fully auditable and validated. This user-friendly system facilitates rapid start-up and close-out processes, allowing you to save valuable time and guaranteeing that any amendments or updates to study protocols are implemented efficiently. As a contract research organization based in India, Innovate Research specializes in clinical research and regulatory affairs, ensuring compliance with US FDA 21 CFR Part 11. The platform features secure electronic signatures and records, role-based access control, and an audit trail. Moreover, it includes an intuitive interface for editing checks and setting up case report forms (CRFs), along with reusable frameworks for items, panels, visits, and pages, enhancing usability and efficiency for clinical trials. Additionally, the comprehensive design of ClinSoft™ supports streamlined workflows, ultimately improving overall productivity in clinical research operations.

Catchtrial is a web-based electronic solution designed for the efficient and rapid management of CRFs, images, and various data types. It stands out as a straightforward, secure, and cost-effective platform, utilized by both large corporations and smaller enterprises for conducting international trials. By replacing traditional paper processes, Catchtrial not only streamlines operations but also generates significant cost reductions. The necessity for physical site visits to collect paper CRFs is eliminated, and users can easily upload and capture images, removing the need for shipping CD-ROMs. Study progress can be monitored directly from sponsors' offices, ensuring they maintain complete control over the process. Furthermore, Catchtrial is distinguished by its ability to offer customizable options and features, making trial management more accessible and efficient compared to other eCRF solutions available in the market today. This adaptability allows users to tailor the platform to their specific needs, further enhancing its appeal for diverse trial management scenarios.

The in-system protocol functions as an all-encompassing training initiative, incorporating fingerprint attendance to bolster security measures. Cronos delivers workflows that are highly adaptable, specifically designed for a variety of studies, including dermal, patch, and other bioavailability-bioequivalence (BA-BE) or early-phase research endeavors. It efficiently captures, cleanses, and manages study data, regardless of whether it originates from traditional paper formats or electronic data capture (EDC) systems. Users are able to extract information into preferred datasets while adhering to industry standards such as CDISC (SDTM). The EDC tool boasts real-time activity tracking, and its Bedside Data Collection features enable faster, paperless evaluations. Additionally, Cronos encompasses a sample inventory and tracking system, providing a data repository that is compliant and ready for regulatory scrutiny. It allows for data e-printing from nearly all BA instruments and software, and includes an online review process that integrates e-stamping and e-signatures within a well-defined workflow. Users have the capability to view projects, export, and archive data seamlessly while generating high-quality statistical reports, tables, listings, and formats in both fixed and customizable layouts with impressive efficiency. This comprehensive system not only simplifies the research workflow but also significantly improves data integrity and accessibility, ensuring that researchers can focus more on their studies and less on administrative tasks. Ultimately, Cronos empowers users to manage their research data with confidence and precision, enhancing the overall quality of their findings.

Our platform for managing clinical trials is engineered to support virtually any form of controlled clinical trial, including randomized studies, and provides a range of randomization algorithms. This versatile software can be easily configured for both paper Clinical Report Forms (CRFs) and electronic CRFs (eCRFs). It is adept at capturing data in various formats and methods, adhering to the specific guidelines you set to maintain data integrity and quality assurance. The system allows for direct Electronic Data Capture (EDC) via eCRFs, or it can generate paper CRFs that can subsequently be entered into the system. Additionally, users can upload a variety of media including images, audio recordings, videos, and documents such as consent forms, with the only constraint being the available storage space. The platform incorporates Double Data Entry and offers thorough exception reporting to ensure accuracy. Furthermore, it features a mechanism to lock records once they have been validated, preventing any further modifications. This extensive functionality significantly bolsters the reliability of the data gathered throughout the trial, thus enhancing the overall research quality. Overall, our platform is designed to streamline the clinical trial process while ensuring the highest standards of data management and security.

Datatrak International, Inc. specializes in providing software-as-a-service solutions that utilize cloud-based technology tailored for the life sciences sector. Their integrated eClinical solution, along with associated services, enhances both the efficiency and cost-effectiveness of clinical trials. The company has crafted a robust, multi-faceted solution that operates on a unified platform, which was further enhanced by the inclusion of service delivery through their Clinical and Consulting Services teams. With a comprehensive suite of software products, Datatrak accelerates the reporting process of clinical research data to both sponsors and regulatory bodies, outpacing the capabilities of disjointed technologies. The aim is to equip teams with features such as role-specific access, version-controlled document management, as well as integrated calendar functionalities, tasks, and contact management. All of these components are seamlessly integrated within their eClinical software offerings, which encompass EDC, CTMS, and various reporting tools. By consolidating these functionalities, Datatrak significantly streamlines the clinical trial process.

ClinAccess™ 5.1 marks a significant advancement in our leading Clinical Data Management System, which is entirely constructed on the powerful SAS® 9 framework. This cutting-edge system enhances the efficiency of clinical data management, streamlines the analysis of clinical trials, and simplifies the preparation of electronic submissions. By allowing data entry to be performed directly into SAS® data sets, it eliminates the tedious task of transferring data from Oracle/SQL to SAS, greatly increasing your team's productivity. ClinAccess™ is designed with user-friendly features for study definitions, data entry, and management, including tools that monitor the progress and quality of ongoing clinical trials. Your data remains consistently organized within SAS® for straightforward access, whether it’s for review, analysis, or submission to regulatory bodies like the FDA. The database architecture is finely tuned to enable swift statistical analysis and reporting, ensuring users experience a significant reduction in the time and effort needed for data analysis, which can accelerate the overall time to market. Furthermore, ClinAccess™ is distinguished by its reliability, extensive auditing functionalities, and strong security protocols, making it an exceptional option for managing clinical data. With ClinAccess™, you can adeptly handle the intricacies of clinical trials while upholding data integrity and compliance standards, thereby ensuring the success of your research endeavors. This comprehensive system empowers organizations to achieve milestones with confidence in their data management processes.

Suvoda stands as a prominent player in the arena of clinical trial technology, concentrating on complex, life-saving research in areas such as oncology, central nervous system disorders, and rare diseases. Founded in 2013, the organization offers a robust platform equipped with Interactive Response Technology (IRT), electronic Consent (eConsent), electronic Clinical Outcome Assessments (eCOA), and ePatient solutions, all designed to optimize critical patient engagements. Their cutting-edge software ensures a seamless user experience, facilitating precise randomization, effective drug supply management, and prompt data gathering. Committed to enhancing patient comprehension and reducing the burdens faced by trial sites, Suvoda's solutions are crafted to adapt to the growing intricacies of clinical research. Headquartered near Philadelphia, with additional branches throughout Europe and Asia, Suvoda has proudly aided in the execution of over 1,500 trials across more than 85 countries, demonstrating their extensive global influence and proficiency in the industry. Their unwavering focus on innovation and high standards establishes them as an essential ally in the progress of clinical research, paving the way for future breakthroughs and transformations in the field.

At Calyx, we recognize that the success of any clinical development project hinges on the integrity of your data, highlighting the crucial role of an effective electronic data collection (EDC) system. Utilized in more than 2,600 clinical trials around the world, Calyx EDC streamlines the collection and reporting of clinical trial data through a platform that is both intuitive and efficient. It is vital to protect your essential data with a dependable partner—contact us to learn how Calyx can bolster the success of your initiative. With Calyx EDC, you acquire the flexibility to seamlessly plan, design, and manage studies, regardless of their complexity. Its comprehensive features are designed to reduce costs, improve site visibility, and enhance overall efficiency, ensuring your trial stays on track. Count on Calyx to be the support you need to navigate the intricate landscape of clinical trials, enabling you to focus on what truly matters. Your journey toward successful clinical outcomes begins with the right partnership.

Discover a holistic and cohesive approach with our Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS), and Electronic Data Capture System (EDC) seamlessly integrated. Our versatile Clinical Trial Software System makes it simple for you to access all your research data effortlessly. You can opt to run Clindex® on your own infrastructure or take advantage of the Fortress Medical Cloud (SaaS – Software as a Service) for added convenience. With global cloud capabilities, your information is safely stored in a SOC 3 certified data center, providing peace of mind. Whether you wish to build your own study database or need support, Clindex® provides all the essential tools you need. Our user-friendly quick start manuals, along with extensive help documentation, guide you thoroughly through the setup process. If you prefer a more tailored approach, our dedicated Clindex services team is available to create a study customized to your specifications, ensuring a seamless and efficient experience. Additionally, the flexibility of our system allows for ongoing improvements and updates, keeping your research at the forefront of technological advancements.

OpenText™ Information Management solutions provide life sciences organizations with the tools needed to leverage data and content insights, improving their decision-making processes and accelerating product development timelines. These solutions facilitate the smooth integration, management, and secure exchange of information across individuals, systems, and devices. By optimizing the use of information assets from research and development to commercialization, companies can take advantage of flexible cloud-native software that functions seamlessly in various environments. OpenText specifically tailored for the life sciences sector greatly speeds up the discovery phase, enabling the extraction of actionable insights that drive innovation throughout the development pipeline. Users can transform research articles into electronic lab notebooks via intelligent capture and harness text mining techniques to reveal valuable insights. Furthermore, the platform excels in extracting knowledge from unstructured text found in clinical trial reports, study protocols, and data pertaining to clinical safety and efficiency. It also provides tools for the intelligent analysis, categorization, and extraction of information from clinical trial documents, thereby reducing the likelihood of costly delays and disruptions in the development process. By harnessing these advanced features, life sciences organizations can significantly improve their operational efficiency and propel their research initiatives forward while remaining competitive in a fast-evolving field. The integration of these tools ultimately enhances collaboration and innovation across the entire organization.

Explore an all-encompassing platform tailored for the seamless research, documentation, and organization of your clinical data. The Nucleus platform simplifies the management of your research data by offering a cohesive environment for the storage of study documentation, clinical datasets, submission materials, and compliant media. With Nucleus Documents, you can adeptly handle documents while ensuring version control for your quality documentation and media assets. You can manage, oversee, and share your organizational content effortlessly, making collaboration smoother than ever. Moreover, you can easily gather and regulate your electronic trial master file documents through our centralized regulatory document management system. Nucleus Coding provides dictionary term coding for both MedDRA and WHODrug dictionaries as a standalone application or integrated within your data capture system, thus offering flexibility and efficiency in your coding processes. This robust solution not only bolsters data integrity but also fosters improved collaboration among your research teams, ensuring that everyone stays informed and aligned. Additionally, the platform’s user-friendly interface enhances overall usability, making it an invaluable tool for clinical research professionals.

Improve the robustness of your evidence by utilizing advanced electronic Patient-Reported Outcomes (ePRO) and electronic Clinical Reported Outcomes (eClinRO). These electronic assessments, collectively referred to as eCOA, effectively capture patients' emotions and functional capabilities during clinical trials. By adopting an electronic approach to clinical data collection, you ensure that the information gathered from patients is not only of superior quality but also adheres to necessary regulatory guidelines. Essentially, eCOA addresses the pitfalls associated with traditional paper diaries, such as readability issues, transcription errors, and data inconsistencies. Moreover, the FDA encourages the implementation of ePRO, which allows patients to express their health experiences through various questionnaires, potentially covering aspects like quality of life and daily activity levels. Conversely, clinician-reported outcomes involve assessments conducted by healthcare professionals, including evaluations such as physical examinations like the Psoriasis Area and Severity Index (PASI). Additionally, performance outcomes assess a patient's capability to perform specific tasks, including timed activities, thereby providing a holistic perspective on their health. In conclusion, embracing eCOA and its related strategies represents a significant advancement toward enhancing the reliability and efficiency of clinical trial methodologies, ultimately benefiting patient care. This shift not only streamlines data collection but also fosters greater patient engagement in their health management.

Data is sourced from multiple avenues such as EDC, EHR, smartphones, mobile devices, and central laboratories. Prism adeptly assimilates this varied data and converts it into actionable insights. By fusing user-friendliness with state-of-the-art features, Prism EDC offers a contemporary method for the collection and management of clinical trial data. In addition to conventional form-based data collection, Prism also aggregates and organizes information from a myriad of sources. Moreover, Prism eSource introduces a revolutionary software solution that allows research teams to directly extract clinical trial data from a site's electronic health record (EHR). This advancement not only boosts efficiency and cuts costs when compared to the previous model—where sites had to repetitively enter the same data into various systems—but also accelerates the process of making new therapies available to patients in need. Consequently, the healthcare sector stands to gain immensely from the efficient processes that Prism enables, ultimately improving patient outcomes and enhancing the quality of care.

The complexity of Modern Interactive Response Technology (IRT) systems is on the rise. The importance of customizable and adaptable IRT solutions is paramount, as these systems are crucial for gathering vital information such as recruitment statistics, clinical trial dropout rates, and patient participation. Choosing a user-friendly, mobile-optimized, and comprehensive platform is essential, built on a foundation of quality, flexibility, and expertise. It is essential to engage with a partner that possesses deep therapeutic insights relevant to today’s risk-based eClinical environment. By integrating state-of-the-art technology with specialized expertise and a commitment to outstanding service, we significantly improve clinical trials, ultimately leading to better patient outcomes. Our profound knowledge of clinical workflows and supply chain intricacies drives innovation, empowering clients with enhanced control over their Randomization and Trial Supply Management (RTSM) processes. Our revolutionary tools not only boost quality assurance but also substantially increase site efficiency and patient adherence. Additionally, our versatile IRT platform is designed to accommodate a diverse range of studies and can achieve complete validation and deployment within just 30 days, thereby optimizing clinical trial procedures. This rapid rollout facilitates quicker data acquisition and contributes to a more streamlined overall trial management experience, ultimately paving the way for more effective clinical research outcomes.

Clinpal is recognized as the leading all-in-one clinical research platform tailored for virtual, hybrid, and direct-to-patient studies. This innovative platform allows patients to connect from any location using a variety of devices, enhancing both convenience and accessibility. Research teams benefit from extensive data and analytics capabilities throughout the entire trial process, while sites enjoy the advantages of having all essential features integrated into a single, user-friendly system, effectively reducing their workload. With Clinpal Build, users can take advantage of an intuitive point-and-click interface, enabling Contract Research Organizations (CROs) and others to quickly and easily set up data, forms, and workflows. The platform's Single Platform feature fully supports clinical trials by covering every aspect, from patient recruitment and data capture to long-term follow-up, ensuring data availability as required. Moreover, Clinpal employs advanced technology that accommodates various formats, allowing for a cohesive online setup; this means that once configured, it functions seamlessly across browsers, mobile devices, or applications. This forward-thinking approach not only simplifies the clinical trial process but also fosters greater engagement from researchers and participants, leading to more efficient study outcomes. Additionally, Clinpal’s commitment to innovation keeps it at the forefront of clinical research advancements, continuously improving user experience and study efficiency.

Discover unparalleled oversight and seamless management with LifeSphere CTMS, an intuitive solution designed specifically for clinical operations teams aiming to boost productivity, stay organized, and streamline procedures. This contemporary cloud-based application focuses on reducing study timelines by optimizing management and automating crucial tasks throughout the clinical trial life cycle. Navigate the complexities of clinical research effortlessly with this powerful trial management tool, which provides complete visibility into all trial activities, ensuring that study teams remain aligned and on schedule. Transform your clinical operations using this comprehensive platform, which integrates payment processing and monitoring, while also guaranteeing smooth connectivity with LifeSphere eTMF. Furthermore, achieve adherence to the TMF Reference Model Exchange Mechanism Standard, which allows for easy document sharing across multiple platforms, thereby enhancing your clinical workflows even more. With LifeSphere CTMS, you can take your clinical trial management to unprecedented levels of efficiency and teamwork, ultimately driving better outcomes for research initiatives. This solution not only simplifies the management process but also empowers teams to focus more on advancing clinical research objectives.

Research teams are increasingly pressured to deliver improved results despite constraints in resources. The advancement of a clinical trial can be greatly obstructed by challenges such as uncoordinated systems, the need for manual data entry, repetitive processes, and scattered information. Therefore, it is crucial to implement a clinical trial management system that effectively integrates and streamlines workflows while providing full transparency; Medidata presents an ideal solution for this need. Rave CTMS is distinguished as the only data-centric platform crafted for efficient and intelligent management of the entire trial process. As an integral part of the Medidata Rave Clinical CloudTM, it includes all the essential features expected from a leading CTMS, along with additional functionalities. With Rave CTMS, your study teams gain the capability to plan and execute all clinical trials in a consistent and unified manner, standardizing activity planning and management at study, country, and site levels. This system facilitates the organization of study/site team creation and activation, tracks patient enrollment and milestones, monitors site performance, and addresses challenges effectively. Furthermore, Rave CTMS fosters improved collaboration and communication among team members, ultimately contributing to more successful trial outcomes, and ensuring that every aspect of the trial is managed with precision and clarity.

Advancing artificial intelligence to eliminate the necessity for trial and error in healthcare, our digital twins enable rapid and reliable clinical trials. We prioritize research in fields such as neuroscience, immunology, and metabolic disorders, among others. TwinRCTs accelerate full enrollment by requiring fewer participants to achieve the same statistical power as traditional trial methods. This innovative strategy drastically cuts down on the time needed for late-stage study enrollment. Furthermore, TwinRCTs improve the detection of treatment effects in early-stage research by increasing statistical power without needing more participants. They allow researchers to make well-informed decisions based on initial findings and assist in attracting additional participants to clinical trials. By utilizing smaller control groups, TwinRCTs also enhance the likelihood of participants receiving the experimental treatment. Our dedication to ensuring that clinical trials with digital twins achieve regulatory approval remains steadfast. Unlearn is leading the charge in revolutionizing the healthcare industry through the pioneering use of artificial intelligence, crafting and applying cutting-edge generative models that utilize extensive datasets gathered from prior patient studies. This shift in methodology not only optimizes research efficiency but also significantly improves the effectiveness of clinical trials. The future of medicine is being reshaped as we continue to refine these innovative approaches.