Alternatives to nQuery

Enhance the quality of data management by directly capturing eSource data during patient interactions. This process incorporates integrated editing and validation mechanisms, allowing users to electronically gather high-quality information, which significantly minimizes errors and inquiries, while facilitating real-time remote oversight. By doing so, the study duration, expenses, and risks are significantly reduced. FDA-endorsed, this innovative eSource approach simplifies and modernizes clinical trials, effectively replacing slow, error-prone monitoring and the transcription process into electronic data capture (EDC) systems. Additionally, tailored for site users, ez-SourceDocx optimizes workflows, alleviates workloads, and ensures adherence to study protocols by guiding sites through properly sequenced visit procedures, which not only confirm the collection of all endpoint data but also encourage timely quality assessments by investigators. Ultimately, this comprehensive system enhances overall clinical trial efficiency and reliability.

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.

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.

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.

Ready by ArcheMedX for Pharma and Biotech Trusts to better equip their trial team, improve decision-making, and reduce study delays By understanding which sites and teams are best equipped to conduct the study, you can avoid the most common causes of study delays. Reduce the time and cost of resolving problems, especially early in a trial. You can be confident that the sites you choose truly understand your patient eligibility requirements. You'll feel more confident that they will be better equipped to help you enroll eligible patients faster, meet enrollment targets, and avoid screen failures. You can be confident that the trial team is fully conversant with the protocol, down to the individual and study objectives. You can predict where there are risks so that you can avoid them and have fewer deviations overall.

CSAM Studies, formerly known as MedSciNet Studies, is a robust and highly adaptable online platform that has demonstrated success in managing clinical studies and trials for two decades. This web-based environment for medical research provides an advanced suite of applications designed for the hosting, administration, and oversight of projects varying in scale and intricacy. The standard offering from CSAM MedSciNet includes all essential elements necessary to establish a fully operational study or clinical trial. Additionally, this benchmark solution is equipped with features that facilitate dynamic and interactive data entry forms, customizable workflow structures, and sophisticated capabilities for data validation, analysis, and exportation. By leveraging these tools, researchers can ensure a comprehensive and efficient approach to managing their clinical studies.

Through the use of the eAdjudication® software managed service, trial leaders can effectively oversee timelines, adapt to fluctuating circumstances and results, and track trends in provider performance and adherence to protocols throughout the extended duration of trials. This innovative, comprehensive managed software service helps prevent unforeseen expenses and timeline violations in Endpoint Adjudication Studies. The eAdjudication® Managed Software Service stands out as the most effective solution for managing Endpoint Adjudication (CEC). By collaborating with the eAdjudication® platform and Ethical's staff, study teams, committee members, and clinical organizations can engage seamlessly in real-time within a user-friendly and GxP-compliant framework, eliminating the inefficiencies, costs, and errors associated with manual processes. Furthermore, the all-inclusive nature of eAdjudication® services facilitates the smooth integration and adoption of EA software across eClinical organizations, enhancing overall operational efficiency. In doing so, it empowers research teams to focus on delivering quality results without being hindered by logistical challenges.

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.

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.

The innovative IWRS facilitates a streamlined and organized drug distribution across various investigation sites, significantly minimizing drug wastage while also adeptly managing intricate randomization processes for both single-arm and extensive multi-arm, multi-center studies. Additionally, the SyMetric Platform's Dynamic Adaptive Randomization feature prevents covariate imbalances among participants, ensuring equitable Treatment Assignment regardless of the sample sizes involved. With the patient management capabilities on the SyMetric Platform, users can efficiently handle Subject Screening and Enrollment, manage Visits, dispense and receive Investigational Product (IP), execute Unblinding, and oversee Withdrawals and Completion processes. Moreover, the robust IP supply management tools embedded in the SyMetric Platform empower drug supply coordinators to maintain stringent control over the supplies dispatched to sites, allowing them to modify supply strategies based on the current treatment arms and updated ratios. This comprehensive approach not only enhances operational efficiency but also strengthens the integrity of clinical trial outcomes.

We offer a comprehensive tracking solution designed specifically for clinical trials. With a simple download onto your trial managers' mobile devices, you can relax as TruLab's advanced blockchain technology handles all the complexities. There's no need to wait for samples to arrive at a central lab to identify potential issues; instead, you can detect data anomalies in real-time as samples progress through the clinical trial process. TruLab facilitates continual remote accessioning of samples, addressing the significant concern that 20% of samples are either lost or deemed unusable during late-stage trials. This situation is unacceptable from ethical, logistical, and financial perspectives. Furthermore, with sample collections increasingly taking place at participants' homes, new challenges in tracking these samples arise. TruLab effectively monitors samples wherever they are located, ensuring that they are accounted for from residences to repositories, thus enhancing the overall integrity of the clinical trial process. By providing seamless tracking capabilities, TruLab empowers trial managers to mitigate risks and improve outcomes.

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.

PASS software offers tools for calculating sample sizes across more than 1100 statistical tests and confidence interval scenarios, which is significantly greater than what any other sample size software can provide. Each of these tools has undergone rigorous validation through published research and established texts. You can familiarize yourself with PASS by trying out a free trial, watching the accompanying video, or navigating through this website. With over 25 years of refinement, PASS has established itself as the top choice for sample size software in clinical trials, pharmaceuticals, and various medical research applications. Moreover, it has gained recognition across numerous other domains where sample size assessment is crucial. In just a few simple steps, PASS enables you to determine the sample size required for a statistical test or confidence interval. Should you require assistance at any stage, PASS provides comprehensive documentation, access to free training videos, and the option to reach out to our team of expert Ph.D. statisticians for support. This commitment to user support ensures that all users can effectively utilize the software to meet their research needs.

The platform features a sleek and user-friendly design, ensuring that navigation and data entry are both swift and effortless; it incorporates access control measures and SSL encryption for security, operates entirely online without the need for installations, and includes built-in monitoring alongside tools for data management and reporting, with a monthly flat rate (SaaS) that is customizable based on the size and duration of the study. Data collection is accelerated through an accessible web interface, allowing users to easily review the status of data completion with visual indicators, while it also employs edit checks and both automatic and manual queries to identify any discrepancies; additionally, it offers source data verification (SDV) and remote reviews through integrated buttons, meticulously tracking all changes made, including the author, date, time, and reason for each modification, and it can generate datasets (e.g., CSV) for subsequent statistical analysis, providing a comprehensive solution for research needs. This robust functionality ensures that users can efficiently manage their data while maintaining high standards of accuracy and security throughout the research process.

Preclinical information is found in many laboratories. It can be stored in multiple systems within the laboratory and with several external partners. Team members are unable to have clear and informed decisions without a unified solution because they lack transparency in core business data. Pristima, a fully integrated digital laboratory execution platform, features intelligent workflows, task automation, and data and information management throughout the entire preclinical process. Xybion's preclinical platform provides a central data repository as well as a standard archive platform. This platform can help you increase productivity and lower costs. With complete transparency across all platforms, gain visibility into the information that is there and take actions based on your current business needs. Effective data management can reduce the time it takes to submit final SENDs from end-of-study.

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

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.

Our leading solution for managing patient randomization and trial supplies is available in various formats, making it the most adaptable and customizable Interactive Response Technology on the market. Whether you're conducting Phase I or Phase IV trials, and regardless of whether your study design is straightforward or involves complex adaptive methodologies, IXRS®3 is equipped to handle any combination of study goals. Additionally, you will benefit from a dedicated team of biostatisticians and integration specialists who are available around the clock to provide support. The functions intended for site users streamline processes that are typically vulnerable to human mistakes, allowing them to correct data independently without needing to contact a Help Desk or worry about compliance issues. Instead of sifting through numerous pages of specifications and legal jargon, users can access clear visual tools that enhance understanding. Furthermore, you can monitor and respond to each development stage of the software build, which helps to prevent unexpected issues during delivery, ensuring a smoother trial experience. This comprehensive approach not only facilitates efficiency but also empowers users with greater control over their trial processes.

Oversee your clinical trial seamlessly through a single platform. Zapclinica offers an eClinical suite tailored to manage and execute every facet of your decentralized clinical trial—whether hybrid or entirely virtual. By automating intricate processes, it helps in spotting anomalies, optimizing resources, and enhancing decision-making alongside collaboration among sponsors, CROs, and study sites. This comprehensive solution significantly cuts down the time and expenses associated with running a successful clinical trial. With Zapclinica, you can handle all study components without the need for additional vendors or third-party services; instead, select the necessary applications within one unified environment, including EDC, ETMF, Payments, Logistics, and much more. Embrace the efficiency of a single platform to streamline your clinical research efforts.

Korio serves as a versatile platform for Randomization & Trial Supply Management (RTSM), emphasizing adaptability, high standards, and efficiency. It is engineered not merely to respond to the challenges of clinical trials but to proactively avert them from arising. Regardless of the trials encountered, Korio is equipped to manage them effectively. Traditional RTSM systems struggle to accommodate the growing complexity of study designs, and inflexible platforms fail to implement necessary RTSM design modifications swiftly in response to clinical trial adjustments. Drawing from extensive practical experience, Korio has created an RTSM solution where adaptability and dependability coexist, blending innovation with seasoned expertise. Enhance your operational efficiency through Korio's user-friendly, role-specific interface, which empowers a diverse range of users—from site personnel and supply managers to clinical operations and data management teams—to work more efficiently and confidently. With Korio, enjoy a consistently managed trial experience that can adapt to your evolving needs. Ultimately, Korio is not just a tool, but a comprehensive solution for modern clinical trial management.

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

EasyTrial.net is an online platform that allows you to access study data anytime and from anywhere. With this system, you can easily engage others by utilizing individual access controls that let you share specific information while restricting access to other data as needed. Moreover, EasyTrial.net adheres to GDPR regulations, ensuring that your data is stored securely. As the principal investigator, you maintain complete control over your data, while EasyTrial.net acts as the data processor, ready to establish data handling agreements upon request. Our expertise lies in data security, with a strong emphasis on IT and cyber protection. Over the years, thousands of clinical trials have been conducted within EasyTrial.net, earning the trust and approval of numerous data regulation authorities, hospitals, and educational institutions across various countries, which attests to the platform's reliability and security. This extensive experience further reinforces our commitment to safeguarding your sensitive information throughout the research process.

Cloudbyz CTMS is a cloud-based trial management platform natively built on Salesforce Cloud. It is aimed at sponsors, clinical research organizations (CRO), and clinical sites for managing end-to-end clinical trial operations. Designed for clinical research, it expedites implementation and drives user adoption. Cloudbyz CTMS comes with an intuitive, straightforward design that allows for quick deployment. Boasting a rich set of features, Cloudbyz CTMS makes it easy for users to manage all aspects of clinical trials, including sites, enrolment, documents, events, milestones, site visit reports, finances, inventory, etc. The solution benefits are listed below- 1. Secure, reliable & scalable 2. Faster time to value 3. Monitor study progress & risks from planning to close-out 4. Seamless collaboration among sponsors, CROs & sites 5. Improved clinical team efficiency

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.

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.

Most Easy-to-Use Clinical Trial Management System (CTMS) 𝐂𝐥𝐢𝐧𝐢𝐨𝐧 𝐂𝐓𝐌𝐒 integrates seamlessly with Clinion EDC and Clinion RTSM to provide detailed and faster access to the entire trial process to address all aspects of Clinical trial management from a single platform: investigator sites, patients enrollment, SAEs, deviations, inclusions, visit scheduling, IP management, milestones, finances, custom reports, and on-demand analytics enables you to improve quality, control risk, and reduce costs. Clinion CTMS is modular in design These modules are available: Admin Module Project Management Site Monitoring Activities Finance and Budget Management Safety Reporting Management of IP Inventory Document Management System Audit/Activity Log Comprehensive dashboards Comprehensive Reports

The in-system protocol serves as a comprehensive training program, integrated with fingerprint attendance for enhanced security. Cronos offers highly customizable workflows tailored for conducting various studies such as dermal, patch, and other bioavailability-bioequivalence (BA-BE) or early-phase research. It enables the capture, cleansing, and efficient management of study data, whether sourced from paper-based or electronic data capture (EDC) trials. Additionally, users can extract data into preferred datasets in compliance with industry standards like CDISC (SDTM). The EDC tool features real-time activity monitoring, and its Bedside Data Collection capabilities facilitate quicker, paperless assessments. Furthermore, Cronos includes a sample inventory and tracking system, ensuring a compliance-ready data repository. It supports data e-printing from nearly all BA instruments and software, along with an online review process complete with e-stamping and e-signatures within a defined workflow. Users can view projects, export, and archive data efficiently while generating high-quality statistical reports, tables, listings, and formats in both fixed and customizable layouts with remarkable ease. This robust system not only streamlines the research process but also enhances overall data integrity and accessibility.

Secure and user friendly cloud-based EDC platform for managing clinical trials and studies of all sizes and complexities: ePRO, eConsent, eCOA, eSource, PROMs, PREMs, functional health assessments and participant education/engagement.

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.

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.

Progressing artificial intelligence to remove the need for trial and error in healthcare, our digital twins facilitate swift and assured clinical trials. We focus on areas such as neuroscience, immunology, and metabolic diseases, among others. TwinRCTs expedite full enrollment by requiring fewer participants to provide equivalent statistical power compared to conventional trial methodologies. This approach significantly reduces the time needed for late-stage study enrollment. Additionally, TwinRCTs enhance the ability to detect treatment effects in early-stage studies by bolstering statistical power without necessitating an increase in participant numbers. They enable researchers to make informed decisions based on initial study outcomes and help attract more participants to trials. By utilizing smaller control groups, TwinRCTs also improve participants' odds of receiving the experimental treatment. Our commitment to positioning clinical trials with digital twins for regulatory success is unwavering. Unlearn is at the forefront of transforming the medical field through the innovative application of artificial intelligence, creating and implementing novel generative models that are trained on vast datasets derived from previous patient studies. This evolution in methodology not only streamlines research but also enhances the overall effectiveness of clinical trials.

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.

Signant Health operates as a worldwide leader in evidence generation, striving to transform the landscape of clinical trials by connecting with patients in their environments and rethinking the route to validation. Their extensive range of clinical technology solutions includes electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician evaluations, and a cohesive eClinical platform. Additionally, they offer patient engagement solutions featuring a user-friendly app, eConsent for informed consent processes, and telemedicine functionalities. Furthermore, Signant Health delivers clinical data and analytics services, which include COA data analysis as well as the aggregation and interpretation of data. With a rich history spanning over three decades, they have played an instrumental role in supporting numerous trials and have been pivotal in hundreds of drug approvals, establishing themselves as a reliable ally for sponsors and CROs eager to provide high-quality data for informed trial decisions and regulatory submissions. Their commitment to innovation continues to shape the future of clinical research.

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

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.

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.

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.

Clinical One RTSM is capable of accommodating various randomization strategies, ranging from the most straightforward to highly intricate studies, all without requiring any programming or coding, which consequently reduces the duration of user acceptance testing. You can take charge of your study with self-service configurations, allowing you to develop a study in just a matter of days rather than weeks. Additionally, you can assess the drug inventory status and make real-time adjustments without needing to consult the vendor, thereby avoiding unnecessary costs and change requests. By implementing changes swiftly, you can eliminate expenses associated with change requests and prevent delays, enabling you to launch your studies almost instantaneously. This platform stands out as the only one that genuinely integrates individuals, processes, and data to streamline and expedite the future of clinical trials. Moreover, the inclusion of virtual components in clinical trials enhances patient engagement and significantly elevates the quality of trial data. To keep pace with the rapidly evolving landscape, it is essential to adopt transformative digital strategies that facilitate quicker study initiations, harmonize data from diverse sources, and optimize workflow efficiency. Such advancements are pivotal for the successful execution of modern clinical research initiatives.

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.

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.

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.

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

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.

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.

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