Alternatives to Veeva SiteVault

We streamline the intricacies involved in managing your complete product lifecycle. Designed for user-friendliness and flexibility to meet your organization’s specific requirements, STARLIMS lab informatics solutions cater to the evolving demands of data management throughout your organization. Our laboratory information management systems (LIMS software) can seamlessly connect with your existing infrastructure, while also pinpointing areas for process enhancement, enabling you to accelerate the market introduction of high-quality and safe products. In doing so, we empower your organization to thrive in a competitive landscape.

Document Control is MediaLab’s document management system. Our online solution empowers lab directors and supervisors to manage their policies, procedures, forms, job aids, and worksheets using configurable review settings, custom approval workflows, automated employee sign-offs, and more! Reduce time spent chasing approval and review signatures while benefiting from email notifications and personalized to-do lists for employees. MediaLab's Document Control supports: • Digital records and version control of all documents, • Standardization across all documents from all sites, • Electronic signatures that meet 21 CFR Part 11 standards, • Customized approval workflows and processes, • Robust searching to easily locate specific documents, and more!

Streamline your document workflows to eliminate inefficiencies that consume valuable time and resources, hindering your growth and ability to secure new studies. Florence eBinders seamlessly connects all your clinical trial systems, automates eRegulatory tasks, shortens contract negotiation duration, monitors study advancement, and facilitates secure remote oversight on a leading eRegulatory, eISF, and eSource platform. With our highly-rated implementation and support teams, your team and study can be set up quickly, ensuring a smooth transition for all users. Most sites become fully operational within just four weeks! By enabling secure access for your monitors and providing remote capabilities for your team, you can significantly decrease the time spent on-site during monitoring visits. Additionally, this approach fosters a more efficient and flexible research environment.

Harnessing actionable insights from the leading AI-driven clinical analytics platform allows your teams to effectively manage risk and enhance performance throughout studies, systems, sites, and vendor relationships. The cutting-edge technology from Saama is specifically crafted to optimize workflows, automate labor-intensive tasks, and foster improved collaboration among various clinical functions such as operations, medical review, data management, biostatistics, and pharmacovigilance. Both sponsors and CROs depend on Saama's capabilities for data aggregation and AI solutions, which facilitate superior decision-making, minimize delays, and drastically reduce costs and timelines associated with drug development. By leveraging Saama's tools, you can accelerate the pace of clinical trial innovation. When your clinical data is centralized and continuously updated, it simplifies the lives of your ClinOps and medical review teams considerably. Furthermore, Data Managers, often undervalued, can shift their focus from repetitive tasks to the critical data points that truly drive project success, ensuring that their expertise is fully utilized in the process. This transformation not only enhances efficiency but also contributes to the overall quality of clinical outcomes.

Experience the forefront of eSource, CTMS, and eRegulatory software designed specifically for clinical trial sites. With CRIO’s top-tier electronic source, you can effortlessly capture source data in real-time, drastically cutting down on paper usage by up to 90% while enhancing data quality by 80%. Gain command over your operations through CRIO’s user-friendly Clinical Trial Management System, allowing you to efficiently schedule patients, monitor financials, and optimize recruiting processes. We proudly present cutting-edge electronic regulatory binders, including the innovative first-ever electronic delegation log, all compliant with 21 CFR Part 11 standards. For clinical trial sponsors, you can perform 100% remote monitoring of your sites’ source data and regulatory documents through a secure online portal. Become a part of our extensive network of over 500 clinical research sites worldwide. Our commitment is to facilitate the growth of your business by streamlining your site’s operations, ensuring that your studies can continue smoothly, regardless of whether you're on-site or not. This way, you can focus on what truly matters: advancing your clinical research initiatives.

A cloud platform that is accessible from anywhere, infinitely scalable, and powered by AI offers collaborative features while adhering to the strictest security and compliance standards. This user-friendly software, designed by specialists in neuroimaging and data science, addresses the specific and complex requirements of the neuroscience field. Customized to suit your particular needs, it supports a wide range of activities, including research, clinical trials, point-of-care applications, algorithm development, and the utilization of brain-related data. The platform facilitates global data aggregation and consolidates imaging studies into a single cloud environment. It provides an efficient, comprehensive management solution for clinical, real-world data, and medical imaging information. Users receive tailored, expert assistance throughout their studies to ensure successful outcomes. Additionally, it features centralized reading capabilities and the option to compare quantitative results against a normative database. The platform also guarantees high-quality, shareable reporting and data export options to streamline the submission approval process, making it an invaluable tool for neuroscience professionals. Furthermore, its innovative design enhances collaboration among researchers and clinicians, fostering a community dedicated to advancing the field.

SiteCentric is an integrated platform designed for clinical trial management, specifically created by research sites to address their unique needs, which combines various functions such as CRM, eISF, CTMS, financial management, and reporting into one cohesive system. This comprehensive solution streamlines and automates processes throughout the entire trial lifecycle, facilitating the nurturing of study leads and organization of pipeline activities with a specialized CRM. It also centralizes essential documents, including budgets, contracts, eReg, training records, and source documentation, to ensure a swift startup process. Additionally, it enhances enrollment efforts through targeted outreach strategies and by utilizing existing databases for more effective recruitment. The platform tracks patient visits meticulously while capturing high-quality eSource data, and conducts internal quality control checks along with maintaining version control and audit-ready eISF documentation. Furthermore, it oversees financial aspects such as budgets, invoicing, payment reconciliation, and patient reimbursements, while also providing leadership dashboards that reveal key performance metrics and trends in real-time, allowing research sites to make informed decisions quickly. Ultimately, SiteCentric empowers research sites by consolidating various functionalities into one efficient platform tailored to enhance clinical trial operations significantly.

Experience total oversight and effortless management with LifeSphere CTMS, a user-friendly solution crafted for clinical operations teams to enhance efficiency, maintain organization, and simplify processes. This modern cloud application is designed to shorten study timelines by streamlining management and automating essential tasks throughout the trial life cycle. Tackle the intricacies of clinical studies with an intuitive yet robust trial management tool that ensures comprehensive visibility of all trial activities, keeping study teams synchronized and punctual. Enhance your clinical operations with this all-in-one platform, which encompasses payment processing and monitoring, while also ensuring a smooth integration with LifeSphere eTMF. Additionally, achieve compliance with the TMF Reference Model Exchange Mechanism Standard, facilitating effortless document sharing across various platforms, thus further optimizing your clinical workflows. With LifeSphere CTMS, you can elevate your clinical trial management to new heights of efficiency and collaboration.

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

Scilligence's Scientific Data Management System (SDMS) offers a unified data storage platform that can connect with numerous instruments and devices, enabling researchers to quickly and securely access essential information. The automation features of SDMS facilitate the collection of data from scientific tools, equipment, or devices, and the subsequent extraction of metadata into a relational database, which enhances data management efficiency and promotes cost reduction. Our system ensures rigorous version control, comprehensive audit trails, and a detailed history of document changes that comply with prevalent regulatory standards. Furthermore, SDMS not only integrates effortlessly with Scilligence applications but also works harmoniously with laboratory instruments and devices for automated data collection. Additionally, it supports the integration of various other database systems and storage options. To safeguard your intellectual property, we provide robust access management at the site, account, and project levels, ensuring that sensitive information remains protected while facilitating collaborative research efforts. This comprehensive approach to data management ultimately empowers scientists to focus on their research while relying on a secure and efficient data infrastructure.

Managing data from various laboratory systems can complicate the retrieval of essential information needed to enhance operational efficiency, often resulting in disjointed workflows. Imagine the potential if you could consolidate information from nearly any laboratory information system, analyzer, or automation setup throughout your organization. Check out the video to discover how this can be achieved. With AlinIQ AMS, Abbott's analyzer management system, you have the ability to harmonize IT and workflow processes across your entire laboratory network. AlinIQ AMS offers an open, scalable solution capable of linking almost any analyzer or automation system to your LIS, facilitating improved data management throughout your operations. By leveraging five distinct functional categories alongside expert guidance, AlinIQ AMS not only boosts your operational efficiency but also enhances the quality of your laboratory information system, ultimately transforming how your lab operates. This innovative approach promises to streamline your processes and improve overall productivity.

Enhance the efficiency of clinical trial operations by optimizing, automating, and analyzing data from all study management activities. Siebel CTMS offers a robust, scalable, and unified trial management platform designed to elevate operational productivity by standardizing workflows in clinical operations while delivering immediate data visibility. With Siebel CTMS, you can oversee and direct trial operations effectively from inception to completion, ensuring a seamless management experience. The system enhances data integrity by allowing customization of workflows to align with specific customer needs across various research studies. Furthermore, Siebel CTMS seamlessly integrates with sophisticated analytics tools that deliver prompt, data-driven insights into clinical programs, empowering you to make well-informed business choices. Accessing accurate and comprehensive clinical trial data in real-time enables swift and efficient decision-making, ultimately leading to improved outcomes in trial management. By leveraging these capabilities, organizations can significantly enhance their operational agility and responsiveness in the competitive clinical research landscape.

eDeviation provides comprehensive tools for assessing and managing Protocol Deviations. It streamlines processes from software design and validation to gathering necessary documentation and exporting information for the Trial Master File (TMF), thereby alleviating the burden on clinical teams who may face risks from improperly assessed or overlooked protocol deviations, whether they occur once or multiple times. As a component of Ethical's eClinical Software Platforms, eDeviation® enhances the efficiency and accuracy of clinical trial management. Whether evaluations are conducted by a dedicated independent committee or by your own research team, our software can be tailored to meet your specific requirements. The integration of forms, workflows, and export functions ensures adherence to GxP standards and fosters effective study management. Additionally, this platform allows study teams, investigators’ sites, and committee members to collaborate online in real-time, facilitating quicker decision-making, reaching consensus, and ensuring the prompt handling of protocol deviation assessments and management. Ultimately, eDeviation® enhances the overall integrity and efficiency of clinical trial processes, contributing to better outcomes in research.

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

Scispot delivers a powerful lab informatics platform that transforms how life science labs operate. Through its configurable LabOS™ ecosystem, teams can select from a unified suite of tools covering ELN, LIMS, SDMS, QMS, and AI capabilities—all accessible through an intuitive no-code interface. Purpose-built for CROs, Diagnostic Labs, and Biotech R&D teams, Scispot addresses critical challenges in Sample Management, Freezer Management, and GxP Compliance. The platform seamlessly connects with 200+ lab instruments and 7,000+ applications, eliminating manual data entry while ensuring regulatory adherence. Scispot's AI-powered analytics convert experimental data into actionable insights, accelerating discovery timelines. With rapid implementation and a focus on user experience, Scispot enables 1000+ lab scientists and operators to standardize processes, maintain compliance, and focus resources on innovation rather than administrative overhead.

Introducing the latest version of eTMF Connect: a solution designed with simplicity at its core while ensuring no compromises are made. We have completely transformed eTMF Connect to deliver a faster, more scalable, and high-performing eTMF solution that meets the demands of both current and future clinical trial landscapes. Enhanced Data Visualizations & Reporting Features. Montrium has integrated a suite of advanced data visualization and reporting tools into eTMF Connect, significantly boosting its business intelligence capabilities. This functionality enables deeper insights across all studies, allowing project teams and clinical operations managers to gain improved visibility into TMF completeness, quality, and timeliness. As a result, these enhancements will elevate your TMF strategy across various clinical programs. Each clinical trial presents its own unique challenges, and the intricacies and regional variations involved can add significant complexity that might keep even seasoned TMF professionals awake at night. It is crucial for your eTMF platform to be adaptable enough to address these diverse challenges and intricacies effectively. By doing so, it ensures that your organization can navigate the complexities of clinical trials with confidence and precision, ultimately leading to more successful outcomes.

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

GoVal is an AI-powered validation software purpose-built to digitize the full validation lifecycle across pharma, biotech, medical device, and other life science industries. From Computer System Validation (CSV), Equipment Qualification, and various validation requirements to broader GxP compliance needs, it leverages intelligent automation to deliver streamlined digital workflows—all within a secure, paperless framework. Its customizable platform with role-based workflows enables automated reviews, approvals, and real-time visibility, backed by compliant e-signatures and audit-ready traceability. Built to meet 21 CFR Part 11, EU Annex 11, and leading GxP standards, GoVal ensures seamless regulatory alignment. Risk-based strategies at the URS level empower teams to drive targeted mitigation planning and precise test case design. GoVal AI goes further—accelerating validation timelines through generative assistance for risk assessments, documentation, and test development. An in-built Document Management System (DMS) allows users to securely store, organize, and retrieve validation documents as needed—supporting data integrity, traceability, and effortless access during audits. Integrated deviation management, change tracking, and continuously updated data simplify inspections while reducing manual errors. The result: faster deployment, lower compliance costs, and stronger ROI—delivered with clarity, control, and continuous compliance.

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.

Research teams are facing rising demands to achieve greater outcomes with limited resources. The progress of a trial can be significantly hindered by issues such as disconnected systems, the necessity for manual data entry, repetitive workflows, and fragmented information. Thus, it is essential to adopt a clinical trial management system that integrates and optimizes workflows while ensuring complete transparency, and Medidata offers the perfect solution. Rave CTMS stands out as the sole data-centric platform designed for efficient and intelligent end-to-end trial management. As a key component of the Medidata Rave Clinical CloudTM, it encompasses all the features you would expect from a top-tier CTMS and even more. Rave CTMS empowers your study teams to plan and oversee all clinical trials consistently and cohesively, standardizing activity planning and management across study, country, and site levels. This includes managing the creation and activation of study/site teams, tracking patient enrollment and milestones, monitoring sites, and addressing issues effectively. Moreover, with Rave CTMS, you can enhance collaboration and communication among team members, which ultimately leads to better trial outcomes.

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.

Science 37 is a pioneering clinical research organization that focuses on decentralized clinical trials through its innovative Metasite model, which eliminates the need for physical proximity, allowing patients to engage in studies from virtually anywhere. This method significantly broadens accessibility, reaching over 90% of individuals who might be excluded from conventional site-based research, and harnesses the recruiting capabilities equivalent to 20 sites in one location, thereby offering patients the flexibility they desire. The Metasite operates on a proprietary platform that not only streamlines study orchestration but also facilitates the workflow for both patients and research staff, all while efficiently capturing study data without manual reentry. By centralizing personnel, processes, and technologies, this approach guarantees built-in protocol compliance, which leads to enhanced compliance rates and the collection of high-quality data. Science 37's dedicated in-house medical teams, telemedicine investigators, and mobile nursing professionals are well-versed in the conduct of remote trials spanning various therapeutic areas, thus ensuring comprehensive outreach. This commitment to innovative trial methodologies positions Science 37 at the forefront of transforming the landscape of clinical research.

Effectively monitor clinical trials from start to finish with Ennov’s comprehensive Clinical Trial Management software. Each year, clinical trial sponsors search for new ways to improve the efficiency and reduce the costs associated with running their trials. Investigational site efficiency and productivity can be improved by centralizing information, actively monitoring progress, automating schedules, managing finances, and providing accurate reporting and metrics. With the Ennov CTMS, trial sponsors and CROs are able to actively address all aspects of trial management from a single platform: investigator sites, patients, SAEs, deviations, inclusions, visit reports, phone contacts, investigational product management, trial facilities, and finances. Study managers can plan and track their trials in real time to make better decisions faster. With the Ennov CTMS dashboard functionality, study personnel get on-demand analytics to improve quality, control risk, and reduce costs.

Research has the potential to transform the world, and you deserve access to superior research tools. With LIMS and ELN, you can experience seamless collaboration, efficient project management, task organization, document handling, and spreadsheet functionality, all with a revision history that ensures compliance and data is securely backed up across devices. Many researchers today find themselves piecing together their research processes through a mix of standalone applications, writing notes in OneNote, transferring them into MS Word and Excel, using Dropbox for file sharing, and employing project management software like Asana, only to later print everything for compliance with institutional guidelines. Since its inception in 2007, Docollab has partnered with prominent organizations and institutions to fulfill rigorous workflow and compliance standards, developing an intuitive and powerful platform tailored to meet the diverse needs of individual researchers, small teams, and large multinational corporations alike. The platform offers a user-friendly framework that allows you to manage, organize, and archive all research materials in one centralized location, known as the Electronic Lab Notebook. By structuring your work, projects, and files into organized folders and sub-folders, you can streamline your research process and enhance productivity significantly.

Document management and teamwork are streamlined with myClin, which serves as an interactive and dynamic eTMF solution. You can swiftly upload and share research documents through your secure and centralized myClin channels, facilitating immediate access that speeds up the distribution of essential study updates and training information. With oversight built into the process, our "File it" feature allows you to monitor who has reviewed and comprehended your study materials. This feature not only serves as a record of effective study execution but also tracks training activities such as views, filings, or downloads at both the team and individual levels. Always be prepared for inspections, as our compliance score highlights the engagement levels of each site or study team member with relevant study information. This proactive approach directs you to areas of lower compliance within your study, fostering ongoing improvements in risk management practices. In just a few hours, we can set up a myClin channel for you to explore myClin with your team, making the process exceptionally straightforward. Experience the ease and efficiency that myClin brings to your study management today.

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

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

ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.

Clin'form is an adaptable and powerful electronic Clinical Outcome Assessment (eCOA) platform that aims to simplify clinical trials for both patients and research sites, improve data integrity, and speed up processes for research teams. Its versatility allows it to be used across various protocols and demographics, making it suitable for any type of questionnaire—including Patient-Reported Outcomes (PRO), Observer-Reported Outcomes (ObsRO), Clinician-Reported Outcomes (ClinRO), and diaries—while catering to individuals of all ages, from children to the elderly. The platform is designed to handle diverse population sizes, effectively managing studies that involve anywhere from a small group to over 10,000 participants spread across multiple regions worldwide. Clin'form integrates smoothly with other clinical systems to provide an efficient workflow, supporting various data collection methods such as dedicated tablets or smartphones, the patient's personal device, web access on any browser, and in-person interviews. Noteworthy features include an integrated tele-visit option to accommodate unexpected changes and patient engagement tools that promote high levels of compliance. Additionally, Clin'form's user-friendly interface ensures that both researchers and participants can easily navigate the platform, making the clinical trial experience more streamlined and effective.

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.

Achieve a comprehensive understanding of your research operations by utilizing a robust and standardized clinical trial management system that has been developed in partnership with prominent academic medical and cancer centers. Streamline billing designation processes to promote uniformity across various teams and systems. Enhance your budgeting strategies, ensure accurate routing of charges, and perform more effective audits and monitoring of billing compliance. This integrated approach provides deep visibility and insight into all elements of clinical research, particularly in financial management, thanks to collaboration with elite research institutions. Moreover, by connecting OnCore with your existing electronic medical records (EMR), including seamless integrations with Epic and Cerner, you can significantly boost patient safety, minimize redundant data entry, improve billing compliance, and elevate overall operational efficiency. Ultimately, this system not only simplifies processes but also fosters a more effective research environment.

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

The Datimbi Platform is exceptionally designed for scenarios that require the gathering of extensive and intricately structured data from various contributors or sources, featuring integrated quality assurance measures and the ability to oversee and manage quality and collection processes in real time, along with comprehensive reporting and analysis capabilities. Furthermore, rapid setup is a key feature of our platform. It is tailored for applications like electronic Case Report Forms (eCRFs) in Clinical Trial Management, Social Case Management, econometric event study evaluations, or virtually any data collection and processing workflow that demands efficiency. If your requirements align with these use cases, you can often achieve full deployment and operational status on the platform within just one week! Setting up roles, transitioning workflow statuses, designing complex data collection forms, defining processing rules, managing lists of values, tracking changes, and creating custom email notifications can all be accomplished through an intuitive web interface. Additionally, these functionalities can be administered by your own trained personnel or through a service provided by Datimbi, ensuring flexibility and support for your organization's needs. This combination of speed and ease of use makes the Datimbi Platform a valuable asset for any data-intensive project.

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.

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.

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

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.

Access your study's data instantly via a unified dashboard that keeps you informed about key milestones, overall study progress, and various Key Risk Indicators (KRIs). By proactively identifying and resolving issues as they arise, you can significantly reduce research risks and enhance trial performance. Compare your trial's performance with Lokavant's exclusive data to make the most of your resources and lessen the burden on your study team. Source trial data is seamlessly integrated and standardized in real-time alongside Lokavant's proprietary data and that of its partners. This results in a streamlined, self-service overview of study performance, complete with automated reporting and benchmarking features. Additionally, daily re-forecasting of enrollment and site performance allows for effective comparisons to historical data, yielding valuable insights that can drive better decision-making. This holistic approach ensures that you stay ahead of potential challenges, fostering a more efficient research environment.

Flex Databases is an innovative, unified, and compliant electronic clinical platform that provides software solutions for clinical trials: pharmaceutical companies and CROs. Our system is composed of: - Clinical Trial Management System - Electronic Trial Master File - Project Management & Budgeting solution specifically designed for the clinical trials industry - Pharmacovigilance System - Learning Management System It was possible to create a flexible platform thanks to our unique experience and a qualified team of more than 100 professionals with a deep understanding the clinical trial process.

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

NuGenesis SDMS serves as the automated data repository that supports the NuGenesis laboratory management system. This platform seamlessly consolidates various data types produced by instruments, researchers, and external entities into a unified repository. This allows scientists and collaborators to efficiently commence research, share findings, and exchange data. The system ensures the secure capture, indexing, and storage of laboratory-generated data in compliance with regulatory standards, executing these tasks promptly after any data creation or alteration. Additionally, it simplifies the management of printed data, which encompasses the outputs from instruments. The system is compatible with diverse operating systems, such as Microsoft Windows and UNIX, and it converts data into widely accepted non-proprietary interchange formats, like IUPAC JCAMP-DX. NuGenesis SDMS is proficient at identifying new content across your servers, projects, and data types while swiftly extracting relevant metadata to keep everything organized. This functionality not only enhances efficiency but also ensures that valuable research data is readily accessible and securely stored.

Laboratories that strive for high productivity and efficiency rely on the LabVantage platform, which integrates a laboratory information management system (LIMS), an electronic lab notebook (ELN), a lab execution system (LES), and a scientific data management system (SDMS) into one cohesive solution. This innovative platform is skillfully implemented through a zero-footprint, web browser-based interface, making it accessible for organizations of any scale, with tailored packages for various industries, as well as options for on-premise, cloud-hosted, or SaaS deployment. LabVantage empowers lab managers, scientists, and technicians to optimize the management of all aspects of their work, including instruments, materials, experiments, reports, regulatory compliance, and data integrity. As a prominent player in the field of enterprise laboratory software, LabVantage Solutions is committed to enhancing customer success by converting data into actionable insights that drive laboratory performance. By leveraging this comprehensive system, labs can achieve greater efficiency and accuracy in their operations, ultimately leading to improved research outcomes.

Ripple, a web-based software solution that allows for the management and recruitment of research participants in clinical, translational, and social science studies is an active registry. Ripple was developed by researchers to transform the participant workflow. It is an end-to–end research participant management system that speeds up the entire research process.

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.

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.