Top nQuery Alternatives

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.

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.

In the past few years, the Life Sciences industry has faced fines and settlements totaling almost $15 billion due to compliance issues, highlighting the critical need for companies to adhere to best practices in pharmaceuticals, medical devices, and biotechnology. Furthermore, the management of clinical trials significantly impacts the duration, scope, and financial investments necessary for the advancement of drugs and medical devices. By leveraging OpenText™ Clinical Trial Quality Management System (ctQMS), organizations can ensure compliance, reduce record-keeping costs, and promote collaboration to implement best practices throughout the clinical trial process. This strategic methodology not only boosts operational efficiency but also plays a vital role in the successful development of products. Ultimately, embracing such advanced systems can lead to more innovative solutions in the healthcare landscape.

Data MATRIX provides an all-encompassing SaaS platform tailored specifically for clinical trial management. Established in 2009, the Data MATRIX team has focused on the intricate processing and analysis of clinical data, producing documentation that adheres to the regulations set forth by the Russian Ministry of Health, FDA, and EMA. Our innovative software simplifies the clinical trial workflow, enabling users to effectively oversee and monitor their progress through an online interface. Prior to the initiation of any project, we ensure to thoroughly adjust and validate our software, taking into account every detail necessary for peak performance. With a successful history of completing 180 projects for various pharmaceutical companies, biotech enterprises, and contract research organizations, our solutions have contributed to 6 of the top 10 Big Pharma firms achieving a notable 15% decrease in research and development costs. The commitment of our dedicated team extends beyond projects as they are actively engaged with professional networks that link clinical data professionals such as CDISC, ACDM, SCDM, biostatisticians like ISBC, and medical writers affiliated with EMWA and AMWA. By consistently refining and advancing our offerings, we strive to foster innovation within the clinical research sector, ensuring that our solutions remain at the forefront of industry needs. This commitment to progress not only supports our clients but also enhances the overall landscape of clinical trials globally.

ArcheMedX offers a solution designed for pharmaceutical and biotech trusts to enhance the effectiveness of their trial teams, streamline decision-making processes, and minimize delays in studies. By identifying the most capable sites and teams for conducting trials, organizations can sidestep common pitfalls that lead to study postponements. This approach not only cuts down on the time and expenses associated with problem resolution, particularly in the early phases of a trial, but also ensures that selected sites have a thorough understanding of patient eligibility criteria. Consequently, you can trust that they are better positioned to enroll suitable patients more efficiently, achieve enrollment goals, and reduce screen failure rates. Additionally, the trial team’s deep familiarity with the study protocol and its specific objectives fosters a comprehensive understanding of the project. This proactive strategy allows for the anticipation of potential risks, enabling teams to mitigate them effectively and ultimately resulting in fewer deviations throughout the trial process. Overall, this systematic preparation leads to a smoother and more successful trial execution.

CSAM Studies, previously referred to as MedSciNet Studies, is a powerful and flexible online platform that has effectively facilitated the management of clinical research for the past twenty years. This internet-based resource for medical studies offers an extensive array of applications aimed at the hosting, administration, and supervision of projects of various sizes and complexities. CSAM MedSciNet's standard offerings encompass all critical components needed to launch a fully functional study or clinical trial. Moreover, this exemplary solution is enhanced with features that support dynamic and interactive data entry forms, customizable workflow designs, and advanced tools for data validation, analysis, and exportation. By utilizing these capabilities, researchers can adopt a thorough and efficient strategy for overseeing their clinical trials. As a result, CSAM Studies continues to evolve, meeting the changing demands of medical research with innovative solutions.

The cutting-edge IWRS streamlines and organizes drug distribution across multiple investigation sites, significantly reducing drug waste while effectively handling complex randomization procedures for both single-arm and large-scale multi-arm, multi-center trials. Furthermore, the Dynamic Adaptive Randomization feature of the SyMetric Platform mitigates covariate imbalances among participants, promoting fair Treatment Assignment irrespective of varying sample sizes. With the patient management functionalities provided by the SyMetric Platform, users can proficiently manage Subject Screening and Enrollment, oversee Visits, dispense and receive Investigational Product (IP), carry out Unblinding, and monitor Withdrawals and Completion processes. Additionally, the advanced IP supply management features integrated into the SyMetric Platform enable drug supply coordinators to maintain tight control over the supplies sent to sites, allowing for adjustments in supply strategies based on current treatment arms and updated ratios. This holistic strategy not only boosts operational efficiency but also fortifies the reliability of clinical trial results, ensuring that the research conducted is both thorough and trustworthy. Consequently, the combination of these innovative tools and processes marks a significant advancement in the management of clinical trials.

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.

Our tailored tracking solution is specifically designed for clinical trials, allowing trial managers to effortlessly download the app onto their mobile devices. With TruLab's sophisticated blockchain technology managing all intricate details, you can have peace of mind throughout the process. You no longer have to wait for samples to reach a central lab to spot potential issues; instead, you can monitor data irregularities in real-time as samples navigate through the clinical trial stages. TruLab supports continuous remote accessioning of samples, effectively tackling the notable problem that 20% of samples are either lost or rendered unusable in late-stage trials, a situation that raises ethical, logistical, and financial concerns. As the trend of collecting samples at participants' homes grows, it introduces new challenges in tracking these specimens. TruLab proficiently oversees samples no matter their location, guaranteeing their accountability from participants' residences to storage facilities, thereby bolstering the integrity of the clinical trial process. Moreover, by delivering seamless tracking functionalities, TruLab not only empowers trial managers to reduce risks but also enhances the likelihood of achieving favorable outcomes. Ultimately, this innovative solution streamlines the entire clinical trial journey, ensuring that every sample is meticulously monitored every step of the way.

With the implementation of the eAdjudication® software managed service, trial leaders gain the ability to efficiently manage timelines, respond to varying situations and outcomes, and monitor provider performance and protocol compliance throughout the extensive duration of clinical trials. This cutting-edge managed software service is instrumental in avoiding unexpected costs and breaches in timelines during Endpoint Adjudication Studies. The eAdjudication® Managed Software Service is recognized as the premier solution for overseeing Endpoint Adjudication (CEC). By partnering with the eAdjudication® platform and the staff at Ethical, study teams, committee members, and clinical organizations can collaborate seamlessly in real-time within a user-friendly and GxP-compliant environment, thus reducing the inefficiencies, expenses, and errors that often accompany manual processes. Moreover, the comprehensive nature of eAdjudication® services promotes the smooth integration and implementation of EA software within eClinical organizations, thereby boosting overall operational efficiency. This approach not only streamlines processes but also enables research teams to concentrate on producing high-quality results without the burden of logistical obstacles, ultimately enhancing the integrity of the trial outcomes.

Phoenix CTMS is a cutting-edge web application that combines the capabilities of database software crucial for clinical research into a unified modular framework. Following thorough collaboration with trial sites at the Medical University of Graz, this innovative platform is now publicly accessible under the LGPL 2.1 license. Its remarkable suite of features caters to the operational and regulatory requirements of the clinical front end in academic research, as well as for CROs and hospitals conducting clinical studies across various phases. For those in search of a CDMS that supports extensive JavaScript form scripting on both server and client sides, this system stands out as an excellent choice. It adeptly manages large electronic case report forms (eCRFs), serving as a strong open-source alternative for users who require eCRF functionality. Moreover, its capability to generate complex ad-hoc database queries aids in the identification of appropriate subject candidates through set operations, while also simplifying the management of multiple trials at once, thereby ensuring the effective organization of site personnel and resources. Additionally, the software supports the implementation of diverse processes that comply with ICH GCP guidelines, solidifying its role as a comprehensive solution for clinical trial management and enhancing its utility in a rapidly evolving research landscape.

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.

The platform boasts a modern and intuitive design that facilitates quick navigation and effortless data entry; it features robust access control and SSL encryption for enhanced security, operates completely online without requiring any installations, and comes equipped with internal monitoring alongside comprehensive data management and reporting tools, all offered at a customizable monthly flat rate (SaaS) tailored to the size and duration of the study. Data collection is expedited through a user-friendly web interface that allows users to easily check the progress of data completion using visual indicators, while the system also includes edit checks and both automatic and manual queries to spot any inconsistencies; furthermore, it provides source data verification (SDV) and remote review capabilities through integrated buttons, keeping meticulous records of all modifications with details such as the author, date, time, and reasons for changes. In addition, the platform has the ability to generate datasets in formats like CSV for later statistical analysis, making it a well-rounded solution for various research requirements. This extensive functionality guarantees that users can efficiently oversee their data while upholding rigorous standards of accuracy and security throughout the entire research process, ultimately enhancing the integrity and reliability of their findings.

PASS software provides an extensive array of tools for calculating sample sizes across more than 1,100 statistical tests and confidence interval scenarios, outpacing any other sample size software available in the market. Each tool has been rigorously validated through both published research and authoritative texts. You can explore PASS by signing up for a free trial, viewing the introductory video, or browsing the website. With over 25 years of continuous improvement, PASS has positioned itself as the preferred software for sample size calculations in clinical trials, pharmaceuticals, and a broad spectrum of medical research applications. Additionally, it has earned acclaim in various other fields where precise sample size determination is essential. PASS streamlines the process of calculating the necessary sample size for a statistical test or confidence interval in just a few straightforward steps. If you need help at any point, comprehensive documentation, free training videos, and access to a team of Ph.D. statisticians for expert assistance are readily available. This dedication to user support guarantees that researchers can effectively harness the software to fulfill their specific research requirements. Ultimately, PASS stands out not only for its functionality but also for its commitment to empowering users in their statistical endeavors.

Numerous laboratories house critical preclinical information, often scattered across various systems both internally and with outside partners. This fragmentation leaves team members lacking the transparency necessary for making well-informed decisions, highlighting the urgent need for a consolidated solution. Pristima offers a comprehensive digital laboratory execution platform that incorporates intelligent workflows, automated tasks, and robust data management throughout the preclinical workflow. Similarly, Xybion's preclinical platform serves as a centralized data repository while also acting as a standardized archive solution. By leveraging this platform, organizations can enhance productivity and reduce operational costs significantly. Achieving total transparency across all data platforms allows for improved visibility into existing information, enabling teams to respond effectively to current business requirements. Ultimately, efficient data management not only streamlines processes but can also expedite the submission of final SENDs at the conclusion of studies, making it a critical factor in the preclinical research framework. This integration of systems will ensure that data is not only accessible but also actionable, paving the way for more strategic decision-making.

Axiom has developed Fusion, a unique and affordable eClinical platform designed specifically for small to medium-sized companies in the device, pharmaceutical, and biotech sectors. This comprehensive eClinical Suite offers customizable Modules tailored to your study’s specific requirements. If you are conducting a smaller study, you can select a foundational setup that includes Electronic Data Capture (EDC) and Data Management (DM), along with Adverse Event (AE) and Serious Adverse Event (SAE) tracking. For those seeking enhanced functionalities, Fusion provides advanced Modules such as Inventory Tracking, Randomization and Trial Supply Management (RTSM), and Safety Management to streamline study oversight. The platform also facilitates the electronic collection of study data, even in offline scenarios, ensuring that once an internet connection is available, your information seamlessly syncs with the Fusion databases. This capability enables real-time access to records relevant to subject screening activities, while the Fusion Safety Database effectively supports the management of pharmacovigilance events for improved patient safety. Overall, Fusion stands out as a versatile solution to meet diverse clinical trial needs.

AcceleTrial™ removes the guesswork involved in selecting and activating clinical trial sites. It operates on a Study Start-up Management System (SSMS) that prioritizes objective data over self-reported metrics, granting access to a vast repository of thousands of ranked sites around the world. These sites are assessed based on three crucial criteria: their relevant therapeutic knowledge, experience in conducting clinical trials, and available patient data. By utilizing this data-driven approach, you can effectively identify the best-fit sites globally for your clinical trials. The platform also supports a quick activation of these sites for patient enrollment through an automated "push and pull" system that is available in multiple languages. Moreover, it simplifies the document collection process with pre-filled templates and offers real-time activity tracking capabilities. Users can quickly adopt the system since it is cloud-based, requiring very little IT setup or training to get going. Additionally, AcceleTrial™ seamlessly integrates with CTMS or other clinical trial management software, which significantly boosts overall operational effectiveness. This groundbreaking method not only enhances the precision of site selection but also speeds up the entire process of study initiation, ensuring that trials can commence without unnecessary delays. Ultimately, AcceleTrial™ represents a significant advancement in the efficiency and reliability of clinical trial management.

Our top-tier solution for overseeing patient randomization and trial supplies is offered in multiple formats, making it the most versatile and customizable Interactive Response Technology available today. Whether you're engaged in Phase I through Phase IV trials, and regardless of the complexity of your study design—be it simple or involving sophisticated adaptive methods—IXRS®3 is designed to accommodate any mix of study objectives. You will also have the advantage of a dedicated team of biostatisticians and integration specialists available 24/7 to assist you. The functionalities designed for site users enhance workflows that are usually prone to human error, enabling them to amend data independently without the need to reach out to a Help Desk or worry about compliance challenges. Instead of navigating through extensive pages filled with specifications and legal language, users can utilize intuitive visual tools that improve clarity. Moreover, you can keep track of and react to each phase of the software development process, which helps mitigate unforeseen issues during implementation, ensuring a more seamless trial experience. This holistic approach not only boosts operational efficiency but also grants users greater authority over their trial methodologies. Ultimately, this empowers research teams to conduct their trials with confidence and precision.

Manage your clinical trial effortlessly through a unified platform. Zapclinica provides an eClinical suite designed to oversee and execute every aspect of your decentralized clinical trial, whether it is hybrid or fully virtual. By automating complex processes, it aids in identifying discrepancies, maximizing resources, and improving decision-making as well as collaboration among sponsors, CROs, and study sites. This all-encompassing solution dramatically reduces the time and costs involved in conducting a successful clinical trial. With Zapclinica, you can manage all elements of the study without relying on additional vendors or external services; simply choose the essential applications you require within a single cohesive environment, which includes EDC, ETMF, Payments, Logistics, and more. By utilizing this single platform, you can significantly enhance the efficiency of your clinical research endeavors while ensuring that every detail is meticulously handled.

Korio stands out as a multifunctional platform for Randomization & Trial Supply Management (RTSM), prioritizing flexibility, exceptional quality, and operational efficiency. Its design is not only reactive to clinical trial challenges but also anticipates and mitigates potential issues before they materialize. No matter the complexities of the trials faced, Korio is capable of effectively overseeing them. Many conventional RTSM systems find it difficult to navigate the increasing intricacies of study designs, while rigid platforms are often unable to implement essential RTSM design changes quickly when clinical trials evolve. Leveraging a wealth of practical experience, Korio has developed an RTSM solution that harmonizes adaptability with reliability, merging cutting-edge innovation with deep-rooted expertise. By utilizing Korio’s intuitive, role-specific interface, a wide array of users—including site personnel, supply managers, and clinical operations and data management teams—can enhance their productivity and perform their tasks with greater assurance. With Korio, you are guaranteed a consistently managed trial experience that remains responsive to your changing requirements. In conclusion, Korio transcends being merely a tool; it is a holistic solution tailored for the complexities of contemporary clinical trial management, ensuring that all stakeholders can achieve their goals seamlessly.

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.

EasyTrial.net is a versatile online platform that provides you with the ability to access study data at your convenience, regardless of your location. This innovative system facilitates collaboration by offering tailored access controls, allowing you to selectively share certain information while limiting access to other sensitive data as required. Furthermore, EasyTrial.net is compliant with GDPR standards, guaranteeing the secure storage of your data. As the lead investigator, you retain full authority over your data, while EasyTrial.net serves as the data processor, prepared to finalize data handling agreements whenever necessary. Our specialization in data security is underscored by our strong focus on IT and cybersecurity measures. Throughout the years, a multitude of clinical trials has been successfully managed using EasyTrial.net, which has garnered the trust and endorsement of various data regulation authorities, hospitals, and educational institutions worldwide, highlighting the platform's reliability and security. This vast experience not only demonstrates our capability but also bolsters our dedication to protecting your sensitive information throughout the entirety of the research process, ensuring peace of mind as you navigate your studies.

Cloudbyz CTMS is a cloud-based clinical trial management solution built on the Salesforce Cloud platform, specifically designed for sponsors, clinical research organizations (CROs), and clinical sites to oversee the entire spectrum of clinical trial operations. This platform is tailored for the clinical research field, facilitating swift implementation and fostering user engagement. With its user-friendly and clear interface, Cloudbyz CTMS enables rapid deployment, ensuring that teams can hit the ground running. Equipped with a comprehensive array of features, it simplifies the management of all facets of clinical trials, encompassing site management, participant enrollment, documentation, event tracking, milestone monitoring, site visit reports, financial oversight, and inventory control. The advantages of using Cloudbyz CTMS include the following: 1. A secure, reliable, and scalable infrastructure 2. Accelerated realization of value 3. The ability to track study progress and potential risks from the planning stage through to closure 4. Enhanced collaboration among sponsors, CROs, and clinical sites 5. Boosted efficiency for clinical research teams 6. Overall, the platform significantly enhances the clinical trial process, making it more streamlined and effective.

Our platform provides comprehensive support specifically designed for your clinical trial needs by utilizing state-of-the-art cloud technology. Clinibase enables your organization to realize significant enhancements in both operational efficiency and productivity. Instead of using a one-size-fits-all approach with our Clinical Trial Management System, we recognize that each organization has its own unique systems and workflows. As a result, Clinibase is fully adaptable to cater to the specific requirements and needs of your clinical trial. Additionally, we conduct surveys to pinpoint challenges, emphasize areas needing improvement, and automate various aspects of your daily clinical trial processes. Our social integration tools allow you to quickly find and recruit suitable participants, greatly speeding up the recruitment process. Furthermore, we focus on participant engagement by providing seamless communication channels that encourage high retention rates and create positive experiences for all participants involved. By ensuring that data is meticulously documented and securely managed, you can bolster the integrity of your trials. Moreover, our dedicated approach to customization and efficiency positions Clinibase as an essential ally in your clinical research efforts, ensuring that you can navigate the complexities of clinical trials with confidence and success.

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.

The Clinion Clinical Trial Management System (CTMS) offers an intuitive interface that integrates effortlessly with Clinion EDC and Clinion RTSM, providing rapid and thorough access to all elements of the trial process, thereby managing critical aspects such as investigator sites, patient enrollment, serious adverse events (SAEs), protocol deviations, participant inclusions, visit scheduling, investigational product (IP) management, key milestones, financial oversight, custom reporting, and real-time analytics, which collectively enhance quality, mitigate risks, and lower expenses. Designed with a modular architecture, Clinion CTMS includes a variety of modules tailored for specific needs, such as the Admin Module, Project Management, Site Monitoring Activities, Finance and Budget Management, Safety Reporting, IP Inventory Management, Document Management System, Audit/Activity Log, and provides comprehensive dashboards and reports to facilitate efficient trial oversight.

A reliable and intuitive cloud-based Electronic Data Capture (EDC) platform designed to oversee clinical trials and studies, regardless of their scale or complexity, encompassing features like electronic patient-reported outcomes (ePRO), electronic consent (eConsent), electronic clinical outcome assessments (eCOA), electronic source data (eSource), patient-reported outcome measures (PROMs), patient-reported experience measures (PREMs), functional health assessments, and tools for participant education and engagement. This versatile platform enhances the efficiency of research processes, ensuring that both researchers and participants have a seamless experience throughout the study.

Our cutting-edge Smart Protocol system is engineered to integrate automation and advanced intelligence into the architecture of clinical trials through the use of artificial intelligence. This revolutionary system is reshaping the outdated manual methods that research teams have depended upon for designing clinical trials. In the current digital era, it has become nearly impossible for individuals to meticulously examine every aspect necessary for making informed decisions. Additionally, a multitude of organizations hold precious data that often remains underutilized, with documents stored in systems that lack adequate access. As a result, life science companies may end up making substantial and costly decisions based on inadequate information. Our mission is to shift organizations like yours from a focus on document-centric practices to a more insightful, data-driven framework. We are transforming the research and planning processes for clinical trials by removing barriers that keep data from reaching its intended users. To achieve this, we collect vast amounts of trial-related documents from both your internal assets and the public realm, allowing you to concentrate on what truly matters—enhancing patient outcomes. By streamlining access to essential data, we empower teams to make quicker and more effective informed decisions, ultimately leading to more successful trial results in the future. This holistic approach not only improves efficiency but also fosters innovation in clinical research.

The Trialpack Designer is an intuitive yet powerful software application tailored for the creation of blister packs and cards intended for clinical trials. It is particularly adept at designing packaging for complex blinded studies, such as those involving dosage titrations, double-dummy configurations, and cross-over trials, where a single package might include multiple items. The application effortlessly supplies essential configuration data for the Trialpack PC Controller, Controlled Dosing Systems, and Robotic Packaging Systems. Users can conveniently create various blister shapes, print images, and filling patterns directly from the interface. Moreover, it incorporates detailed user access controls, streamlines workflows with electronic signatures, and maintains a thorough audit trail in adherence to 21 CFR Part 11 regulations. The system also produces reports that offer comprehensive packaging instructions alongside a detailed inventory of material needs, which ensures meticulous documentation and compliance for trial activities. This versatile tool plays a vital role in preserving the integrity and organization of clinical trial packaging, ultimately contributing to the success of the trials conducted. Furthermore, its user-friendly design makes it accessible for professionals at all levels, enhancing collaboration and efficiency throughout the research process.

Our adaptable electronic Case Report Form (eCRF) platform is specifically crafted for non-commercial clinical trials and can easily be customized to align with any study protocol. Created through years of close collaboration with medical professionals and researchers, our eCRF solution emphasizes user-friendliness, featuring an intuitive and flexible interface. Moreover, the system adheres to all required quality standards, and because we have full control over the code, we can continuously improve and adjust it to meet changing regulatory requirements and the evolving nature of clinical trials. This commitment ensures that our platform remains not only relevant but also at the forefront of innovation, effectively addressing the needs and expectations of both researchers and participants. Ultimately, this proactive approach fosters a reliable environment for conducting clinical trials, enhancing the overall quality of research outcomes.

The BizNET-CTM suite provides a robust solution for managing clinical trials, catering to diverse industries such as Contract Research Organizations (CROs), pharmaceuticals, biotechnology, and medical devices. This adaptable platform enables CROs to proficiently plan, oversee, design, implement, monitor, and analyze all facets of clinical trials while adhering to protocol requirements and regulatory guidelines. It encompasses the full spectrum of the clinical research project lifecycle, starting from project management and feasibility evaluations, moving to patient or volunteer enrollment facilitated by advanced iris recognition technology, and including the collection of trial data. A multi-layered review process is integrated into the platform, along with data compilation and subsequent archiving, ensuring comprehensive oversight throughout. Additionally, the BizNET-CTM suite is meticulously designed to manage all essential documents, tasks, processes, relationships, audits, and training required during a clinical trial, thereby optimizing operations and boosting efficiency in clinical research. This forward-thinking approach not only simplifies intricate processes but also significantly improves the accuracy and dependability of trial results, leading to better-informed decisions in the ever-evolving landscape of clinical research. Ultimately, the suite stands as a pivotal resource in advancing the effectiveness of clinical trials across various sectors.

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.

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.

Omda MedSciNet solutions significantly improve the quality, usability, and management of medical data throughout its entire lifecycle, encompassing everything from data collection to analysis. This secure and standardized platform simplifies the process for clinical researchers and professionals in both healthcare and academic settings, facilitating the efficient gathering and analysis of well-structured medical data. The dedicated team at Omda is proficient in creating and managing tailored database applications, in addition to designing clinical studies specifically aimed at advancing medical research and quality registries. The Omda MedSciNet study platform provides a reliable, feature-rich, and highly flexible online environment that is ideal for hosting and managing intricate study and clinical trial systems. With a successful history of over two decades, Omda MedSciNet has adeptly supported studies and clinical trials of diverse scopes and sizes. Standard implementations include a wide range of essential components required for launching fully operational studies or trials, ensuring that researchers are equipped with all the necessary tools. This unwavering commitment to quality and customization not only enhances the user experience but also solidifies Omda MedSciNet's position as a frontrunner in medical data management, continuously evolving to meet the needs of the research community. By prioritizing innovation, Omda MedSciNet remains at the forefront of advancements in the healthcare data landscape.

The Protocol Manager plays a crucial role in clinical operations by managing global trials across different phases of drug, device, biologic, and vaccine development. It establishes essential Standard Operating Procedures (SOPs) to ensure adherence to FDA's 21 CFR part 11 regulations. Utilizing Web Services technology, the platform enables seamless and automatic integration with a variety of popular EDC and IVRS solutions. For systems that do not support Web Services, an export/import feature is provided to facilitate integration. This all-encompassing tool includes a robust tracking system and database, enabling effective management of diverse trial information and metrics, which significantly boosts operational efficiency. Furthermore, it allows organizations to uphold stringent oversight throughout the trial process, safeguarding data integrity and ensuring compliance at each phase. As a result, the Protocol Manager not only streamlines operations but also supports the successful execution of clinical trials by promoting transparency and accountability.

Clinevo's electronic Trial Master File (eTMF) provides a streamlined digital platform for the organization and archiving of documents, images, and various digital assets pertinent to clinical trials. This eTMF is designed with an integrated DIA reference model and adheres to regulatory requirements. In addition to this, Clinevo features the MICC Intake, a web-based tool tailored for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) experts, enabling them to efficiently log, track, and manage Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Moreover, Clinevo Safety acts as a robust cloud-based system that simplifies the Pharmacovigilance process while ensuring compliance with regulations, covering PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals all within one unified platform. Additionally, the Clinevo Website Intake tool can be easily integrated with Sponsor or CRO websites, providing an intuitive web interface for consumers and reporters to access and submit reports effortlessly. This comprehensive range of tools not only streamlines clinical trial management but also significantly enhances safety reporting efficiency and effectiveness. Ultimately, Clinevo's innovative solutions are designed to meet the evolving needs of the clinical research landscape.

Improve the efficiency of regulatory operations within your organization to strengthen compliance and promote research progress. Veeva SiteVault streamlines the management of clinical trials by consolidating regulatory responsibilities, resulting in heightened effectiveness and adherence to necessary regulations. You can manage regulatory and source documents through a single platform that meets 21 CFR Part 11 and HIPAA requirements. With real-time data across all trials, SiteVault Enterprise enhances operational performance, speeds up study initiation, and supports rapid, high-quality trial management. Move away from manual processes and personalize your workflows to improve both quality and speed in study activation. By providing monitors with secure, direct access to your regulatory and source documents, you eliminate the complications associated with EMR access and document redaction. Additionally, you can customize your workflows, create reports, and develop dashboards that offer valuable insights into start-up timelines and regulatory processes, ultimately driving improved results for your clinical trials. This holistic strategy not only simplifies processes but also fosters greater collaboration among teams, enabling better communication and efficiency throughout the trial phases. As a result, your organization can achieve its research goals while maintaining rigorous compliance standards.

Clinical One RTSM offers a versatile range of randomization techniques suited for both simple and complex studies, eliminating the need for programming or coding, which shortens user acceptance testing times. With the ability to self-configure your study, you can create and launch it in a matter of days instead of weeks, significantly speeding up the process. You also have the capability to monitor drug inventory levels and make instantaneous changes independently of the vendor, which helps in cutting costs associated with unnecessary change requests. By facilitating rapid adjustments, you can further reduce expenses linked to change requests and avoid delays, allowing for almost immediate study launches. This platform uniquely integrates people, processes, and data, which is crucial for enhancing the effectiveness and efficiency of clinical trials. Additionally, the incorporation of virtual elements within clinical trials not only fosters greater patient involvement but also improves the overall quality of the trial data collected. To remain competitive in the fast-paced clinical research arena, it is imperative to embrace innovative digital strategies that support quicker study start-ups, synchronize data from multiple sources, and streamline workflows. Such improvements are essential for the successful delivery of contemporary clinical research projects and ultimately contribute to advancing healthcare outcomes.

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.

In the field of clinical research, meticulous organization is crucial for achieving effective outcomes. The challenge of deploying the right resources at the right time becomes particularly pronounced when it comes to managing documents during a clinical trial. GRAVITY has emerged as a trusted solution for overseeing site files and trial master files. We have reimagined these documents into an accessible and unified electronic format, which significantly improves document management by offering a structured and practical system. Acting as an integrated eTMF and eISF platform, GRAVITY functions as a comprehensive cloud-based Document Management System (DMS), serving as a central hub for sponsors, contract research organizations (CROs), and research sites. Additionally, GRAVITY can be utilized independently by each stakeholder when required. As soon as a site is selected for a clinical trial, there is a surge of incoming documents that need to be managed with precision. GRAVITY incorporates a unique feature that tracks vital document management while alerting users to any documents approaching their expiration dates, thereby promoting compliance and operational efficiency throughout the trial. This forward-thinking strategy not only simplifies processes but also significantly elevates the overall quality of clinical research initiatives. Ultimately, GRAVITY stands as a testament to the advancements in document management technology within the clinical research landscape.

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.

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.

SimpleCTMS was designed to provide the benefits of a Clinical Trial Management System (CTMS) without the substantial upfront investments in finances and resources that are often associated with traditional enterprise solutions, as well as the drawbacks of relying on spreadsheet trackers. This innovative platform presents an adaptable and cost-effective solution for emerging drug developers, helping to improve the management, efficiency, and initial expenses involved in clinical trial operations. Clients enjoy the advantage of a dedicated manager who provides proactive assistance and strategic advice tailored to their needs. In addition, all users have access to technical support from our expert team of clinical software specialists, ensuring that they receive the help they need whenever challenges arise. While customized training and professional services are available for an additional fee, the system is built on a strong quality framework that incorporates validated software processes, guaranteeing both reliability and efficiency during its implementation. The focus on user support and personalized services underscores SimpleCTMS's dedication to promoting successful clinical trials, ultimately contributing to improved outcomes in the drug development process. By prioritizing these elements, SimpleCTMS positions itself as a vital partner for organizations navigating the complexities of clinical research.

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.

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.

DSG, Inc., a prominent name in the eClinical space, provides an extensive range of cutting-edge technology solutions alongside comprehensive data management services tailored for the international clinical research sector. With its eClinical platform, DSG delivers both a competitive edge and ensures timely project completion. Their innovative solutions have facilitated numerous clinical trials worldwide, leveraging the acclaimed eCaseLink™ platform and eCaseLinkDesign for enterprise-level applications. Established in 1992, the company proudly holds the SCDM Data Driven Innovation Award, highlighting its commitment to excellence in the industry. DSG continues to evolve and enhance its offerings, demonstrating its dedication to advancing clinical research methodologies.

Intrinsic's Clinical Trial Management System (Intrinsic’s CTMS®) is designed with a strong emphasis on user experience, seeking to minimize data entry and improve proactive study oversight. As a cloud-based solution with a streamlined interface, it facilitates thorough management of clinical studies at multiple levels and adopts a task-oriented methodology, representing a notable evolution in trial management tools. Remarkably, Intrinsic® is the first CTMS to achieve seamless compatibility with all Microsoft applications, including Outlook, Excel, SharePoint, and Power BI. The launch of Dynamic Worksheets allows users to easily import extensive datasets and updates from CROs through their clinical trial management software, removing the necessity for complicated system integrations while enabling the creation of 'live' exports for immediate analysis and reporting. Furthermore, Intrinsic CTMS® leverages Power BI, a cloud-based reporting tool, which enables users to generate reports from other clinical systems, such as EDC and IRT, without the complications and costs associated with creating extensive data warehouses. This groundbreaking methodology not only streamlines data management processes but also significantly boosts the overall effectiveness of clinical trial operations. The focus on user-centric design and integration capabilities positions Intrinsic CTMS® as a leader in the evolving landscape of clinical trial management solutions.

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.

Clario CTMS provides a seamless, all-encompassing platform for overseeing clinical trials, significantly improving both data management and workflow efficiency while ensuring the delivery of top-tier data for each study, which in turn results in notable reductions in time, labor, and operational expenses. This cloud-centric solution enables users to monitor and manage real-time operational metrics from any location at any time, offering exceptional flexibility in trial administration. By incorporating a Microsoft Office-based environment, Clario CTMS consolidates fragmented clinical trials into a cohesive and efficient workspace, making use of widely recognized office tools. The effective, two-way data exchange between Clario CTMS and SharePoint, along with other Microsoft applications, establishes a strong and efficient framework. Furthermore, the combination of Office features with clinical processes helps to lessen administrative burdens, reduce back-office documentation, and achieve a significantly lower total cost of ownership for organizations. The integration features of Clario CTMS not only boost operational productivity but also promote teamwork among those involved in clinical trials. Overall, this innovative approach not only streamlines processes but also positions organizations for greater success in managing their clinical research efforts.

Novatek's Clinical Assay Management software is a groundbreaking tool that provides a systematic approach to the collection, management, and preservation of clinical research data integrity. It diligently tracks and organizes sample information across the complete analytical process, ensuring that there is one definitive and reliable version of all clinical and analytical datasets. In addition, this software aids organizations in overseeing their studies related to specific products in development, offering a structured framework for clinical trials to ensure that every necessary step is executed efficiently and punctually. By improving organization and continuity, this application significantly boosts the overall quality and success of clinical research projects, making it an essential asset for research teams. Its capabilities ultimately foster a more streamlined approach to managing complex data, enhancing the potential for impactful research outcomes.