Alternatives to Chronicles CTMS

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.

OpenText™ Information Management solutions empower organizations in the life sciences sector to harness data and content insights, enhancing their decision-making and speeding up product development. These tools enable seamless integration, management, and secure sharing of information among individuals, systems, and devices. By utilizing information assets effectively from research and development through to commercialization, organizations can benefit from adaptable cloud-native software that operates in any environment. OpenText for life sciences significantly accelerates the discovery process, facilitating the extraction of actionable insights that foster innovation in the pipeline. Users can convert research papers into electronic lab notebooks through intelligent capture, and uncover valuable insights using text mining techniques. Moreover, the platform allows for the extraction of knowledge hidden within unstructured text of clinical trial reports, study protocols, and findings related to clinical safety and efficiency. It also offers methods to intelligently analyze, categorize, and extract information from clinical trial documents, ultimately minimizing the risk of expensive delays and interruptions in the development process. By effectively utilizing these advanced capabilities, life sciences organizations can significantly enhance their operational efficiency and drive forward their research initiatives.

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.

Discover a comprehensive platform designed for researching, documenting, and organizing your clinical data seamlessly. The Nucleus platform streamlines your research data management, providing a unified space for storing study documentation, clinical datasets, submission materials, and compliant media. With Nucleus Documents, you can efficiently manage documents and maintain version control for your quality documentation and media assets. Easily oversee, manage, and share your organizational content without hassle. Additionally, effortlessly compile and regulate your electronic trial master file documents through our centralized regulatory document management system. Nucleus Coding facilitates dictionary term coding for both MedDRA and WHODrug dictionaries, available as a standalone application or integrated within your data capture system, ensuring flexibility and efficiency in your coding processes. This comprehensive solution not only enhances data integrity but also optimizes collaboration across your research teams.

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

Clinevo's electronic Trial Master File (eTMF) is a user-friendly digital solution for the organization and storage of documents, images, and various digital assets related to clinical trials. This eTMF incorporates an integrated DIA reference model and complies with regulatory standards. Additionally, Clinevo offers the MICC Intake, a web-based platform designed for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) professionals to efficiently log, track, and monitor Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Furthermore, Clinevo Safety serves as a comprehensive cloud-based system that ensures ease of use and regulatory compliance throughout the entire Pharmacovigilance process, encompassing PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals, all within a single platform. Lastly, the Clinevo Website Intake tool can seamlessly integrate with Sponsor or CRO websites, offering consumers and reporters an intuitive web interface for easy access and reporting. This innovative suite of tools enhances the efficiency and effectiveness of clinical trial management and safety reporting.

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.

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

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.

Clinion's electronic trial master file (eTMF) system offers distinctive functionalities that enhance the ease of storage, retrieval, and oversight of documents. With its intuitive user interface, it stands out as the preferred solution for managing clinical trial documentation efficiently. This streamlined approach not only saves time but also ensures compliance and organization throughout the trial process.

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

The BizNET-CTM suite offers a comprehensive clinical trials management solution tailored for various sectors, including Contract Research Organizations (CROs), pharmaceuticals, biotechnology, and medical device industries. This versatile platform empowers CROs to effectively plan, manage, design, execute, monitor, and analyze activities and data related to clinical trials, ensuring compliance with both protocol obligations and regulatory standards. It serves as an all-encompassing solution that addresses the entire clinical research project lifecycle, beginning with project management and feasibility assessments, advancing through volunteer or patient enrollment facilitated by iris recognition technology, and encompassing the capture of trial data. The platform incorporates a multi-tiered review process, data compilation, and eventual data archiving, ensuring thorough oversight. Moreover, the BizNET-CTM suite is specifically crafted to oversee all necessary documents, tasks, processes, relationships, audits, and training that must be managed throughout the entirety of a clinical trial, thereby streamlining operations and enhancing efficiency in clinical research. This innovative approach not only simplifies complex processes but also enhances the accuracy and reliability of trial outcomes.

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.

AcceleTrial™ eliminates uncertainties in identifying and activating clinical trial sites. Our Study Start-up Management System (SSMS) relies on objective data rather than self-reported information. With AcceleTrial™, you gain access to a comprehensive database of thousands of globally ranked and indexed sites, evaluated based on their specific therapeutic expertise, clinical trial experience, and patient data. This system allows for an objective pairing of the most suitable sites worldwide with the relevant data on expertise, experience, and patient demographics for your clinical trials. You can swiftly engage the right sites to commence patient enrollment through AcceleTrial™'s automated “push and pull” functionality, available in multiple languages. The platform simplifies the process of gathering necessary documents with pre-filled templates and enables real-time tracking of activities. You can begin utilizing the system immediately, as it is a cloud-based solution that requires minimal IT infrastructure or training. Moreover, AcceleTrial™ can be seamlessly integrated with CTMS or other existing clinical trial management systems for enhanced efficiency. This ensures a streamlined approach to clinical trial management, allowing researchers to focus on their core objectives.

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.

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.

Our innovative Smart Protocol system is designed to infuse automation and intelligence into the design of clinical trials using artificial intelligence. This groundbreaking solution is transforming the traditional manual processes that research teams have relied on to create clinical trials. In today’s digital landscape, it is practically impossible for individuals to thoroughly analyze every detail pertinent to a decision. Furthermore, many organizations possess valuable data that often goes untapped, with documents frequently stored in repositories that lack visibility. Consequently, life science companies may find themselves making significant and expensive choices based on insufficient information. Our goal is to transition organizations like yours from a document-centric approach to a more insightful, data-driven methodology. We are redefining the research and planning of clinical trials by eliminating the obstacles that separate data from its end-users. To facilitate this, we gather extensive amounts of trial-related documents from both your resources and the public domain, so you can focus on what truly matters—delivering better outcomes for patients. By streamlining access to critical data, we empower teams to make informed decisions faster and more effectively.

Trialpack Designer is a user-friendly yet robust application designed for creating blister packs and cards specifically for clinical trials. This tool excels in designing packaging for intricate blinded studies, including dosage titrations, double-dummy setups, and cross-over trials, where a single pack may contain various products. It seamlessly supplies configuration information for the Trialpack PC Controller, the Controlled Dosing Systems, and the Robotic Packaging Systems. Users can easily create blister shapes, print images, and filling patterns directly on the screen. Additionally, it offers highly detailed user access controls, efficient workflow capabilities with electronic signatures, and a comprehensive audit trail that complies with 21 CFR Part 11 regulations. The system also generates reports that provide in-depth packaging instructions along with a breakdown of material requirements, ensuring thorough documentation and compliance for trial processes. This multifaceted tool is essential for maintaining the integrity and organization of clinical trial packaging.

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

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

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

Data MATRIX offers a comprehensive SaaS solution specifically designed for clinical trials. Since its inception in 2009, the Data MATRIX team has specialized in the processing and analysis of clinical data, creating documents that comply with the standards set by the Russian Ministry of Health, FDA, and EMA. Our software streamlines clinical trial processes, allowing users to efficiently manage and track progress online. Before launching a project, we meticulously adjust and validate our software to ensure that every aspect is considered for optimal performance. With a proven track record of completing 180 projects for pharmaceutical companies, biotech firms, and CROs, our solutions have led 6 out of the top 10 Big Pharma companies to achieve a 15% reduction in R&D expenses. Our dedicated team members take pride in their involvement with professional organizations that connect clinical data professionals such as CDISC, ACDM, SCDM, biostatisticians like ISBC, and medical writers associated with EMWA and AMWA. By continually enhancing our offerings, we remain committed to driving innovation in the clinical research landscape.

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.

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.

SimpleCTMS was created to deliver the advantages of a Clinical Trial Management System (CTMS) while avoiding the heavy initial financial and resource investments typical of conventional enterprise solutions, as well as the limitations posed by using spreadsheet trackers. This platform offers emerging drug developers a flexible and budget-friendly way to enhance the management, effectiveness, and initial costs of clinical trial operations. Clients benefit from the assistance of a dedicated manager who offers proactive support and strategic guidance. Additionally, all users can access technical help from our specialized team of clinical software professionals. While customized training and professional services are offered for an extra fee, the system is supported by a robust quality framework utilizing validated software processes, ensuring reliability and efficiency throughout its use. Furthermore, the emphasis on user support and tailored services reinforces SimpleCTMS’s commitment to facilitating successful clinical trials.

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.

Enhance the efficiency of regulatory operations within your organization to bolster compliance and facilitate research advancements. Veeva SiteVault simplifies the process of managing clinical trials by integrating your regulatory tasks, leading to improved effectiveness and adherence to regulations. You can oversee regulatory and source documents through a unified platform that complies with 21 CFR Part 11 and HIPAA standards. With real-time insights across all trials, SiteVault Enterprise boosts operational effectiveness, accelerates study initiation, and fosters swift, high-quality trial management. Transition away from manual workflows and customize your own processes to enhance both quality and speed in study activation. By granting monitors secure, direct access to your regulatory and source documents, you eliminate the hassles of EMR access and document redaction. Furthermore, you can tailor your workflows, generate reports, and create dashboards to gain deeper insights into start-up timelines and regulatory workflows, ultimately driving better outcomes for your clinical trials. This comprehensive approach not only streamlines processes but also enhances collaboration across teams.

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

Historically, managing clinical trials at investigator sites involved either the cumbersome task of maintaining numerous shared spreadsheets or investing in costly software that often did not fit the Australian context. MAISi represents a revolutionary shift in this landscape. Originating in 2001 as a data repository for clinical trials at a prominent hospital, MAISi has transformed into an advanced workflow application designed to streamline various functions within research units. Serving as a centralized database, MAISi efficiently organizes information related to studies and the corresponding business units that manage them. This structured approach enhances management decision-making capabilities. Individual staff members within each business unit can access specific data pertaining to their studies, patients, investigators, and study team members, while those with broader access rights, typically Financial Officers and System Administrators, can view comprehensive data across all units. Additionally, this streamlined access promotes collaboration and improves overall operational efficiency.

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.

Protocol Manager is instrumental for clinical operations in overseeing global trials across various phases of drug, device, biologic, and vaccine development. By implementing the necessary Standard Operating Procedures (SOPs), Protocol Manager ensures compliance with the FDA’s 21 CFR part 11 regulations. The platform utilizes Web Services technology to facilitate effortless and automatic integration with numerous widely-used EDC and IVRS solutions. For those systems that lack Web Services compatibility, an export/import mechanism is available for integration. This comprehensive tool features a powerful tracking system and database that effectively manages a wide range of trial information and metrics, enhancing overall operational efficiency. Additionally, it empowers organizations to maintain rigorous oversight throughout the trial process, ensuring data integrity and compliance at every stage.

Leapcure stands at the forefront of patient recruitment and engagement, bridging the gap between clinical trial sponsors and suitable participants. By leveraging cutting-edge technology and innovative methodologies, we aim to boost both trial enrollment and patient results. Our platform simplifies the recruitment process, allowing for the rapid and efficient identification of qualified candidates for clinical trials. Committed to enhancing medical research, Leapcure strives to make clinical trials more inclusive and impactful. We collaborate intimately with both sponsors and participants to ensure seamless and fruitful trial experiences, which play a crucial role in the advancement of new therapies and treatments. Through our efforts, we are not only improving access to clinical trials but also fostering a more efficient pathway for medical breakthroughs.

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.

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.

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.

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

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

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.

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.

Comprehensive research management solutions are tailored to assist you in securing funding, achieving outcomes, and overseeing all related processes more efficiently with eRA Research Software. Across the globe, a growing number of top-tier research institutions, universities, and corporate entities have opted for the InfoEd Research Software Solution to enhance cost efficiency, boost data integrity, streamline administrative workflows, and expedite compliance within electronic research administration, surpassing other options in research compliance software or eRA tools. We firmly believe that a deep understanding of the industry and its nuances forms the cornerstone of exceptional software development in the realm of research administration, leading to an unmatched collection of technological applications for research support, professional services software, and specialized educational programs by InfoEd Global, all crafted to meet the evolving needs of contemporary research environments. This commitment to excellence ensures that our clients are well-equipped to navigate the complexities of modern research endeavors.

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.

Data flows in from various channels, including EDC, EHR, smartphones, mobile devices, and central laboratories. Prism expertly integrates this diverse information and transforms it into usable knowledge. By combining user-friendliness with cutting-edge features, Prism EDC presents a modern approach to collecting and managing clinical trial data. Beyond traditional form-based data gathering, Prism also consolidates and organizes information from a wide range of sources. Additionally, Prism eSource offers a groundbreaking software solution that enables research teams to directly pull clinical trial data from a site's electronic health record (EHR). This innovation not only enhances efficiency and reduces costs compared to the existing model—where sites redundantly input the same data into multiple systems—but also speeds up the availability of new therapies to patients in need. As a result, the healthcare industry stands to benefit significantly from the streamlined processes that Prism facilitates.

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.

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

Longboat is a cloud-based solution designed to support clinical trials, offering an integrated Guided Compliance toolset that assists users consistently throughout the process. By supplying clinical trial site personnel with essential resources, Longboat enables them to concentrate on patient care. Additionally, it allows participants to access vital study details and receive reminders for upcoming visits. The platform facilitates the streamlined management of any amendments to the clinical trial protocol, ensuring a smooth and controlled rollout. Furthermore, it centralizes the secure sharing of regulated documents among sponsors, CROs, and sites, which significantly enhances the startup process and simplifies traditionally labor-intensive tasks for all research stakeholders. Through a unified support platform, all key participants—including clinical operations teams, monitors, site personnel, and trial participants—can access customized content that addresses their individual requirements. This comprehensive approach ensures that site staff are equipped with the necessary tools and resources to remain engaged and compliant while prioritizing the needs of participants. In doing so, Longboat not only improves operational efficiency but also elevates the overall experience for everyone involved in the clinical trial.

The premier clinical trial management system, specifically designed to overcome the technical challenges of managing clinical trials. CTMS Master makes it easier for users to communicate, reduces manual work, and eliminates redundant data and tasks. This allows for more efficient trial conduct. A Site Visit Report tool that integrates with an automated workflow eliminates duplicate data entry. It also facilitates the creation and distribution of out-of-the box Site Visit Reports (SVR). Standard templates can be used for site and project documents, budgets, events, milestones and site visit reports. CTMS Master offers more than 100 metrics/statistics to help you track clinical study sites, countries, and projects. It also includes 80+ standard reports and ad-hoc reporting capabilities. CTMS Master allows you to create site-specific budgets using a default template, track accrued and future obligations, and define automatic or manual approval for each payment type.

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.

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

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