Protocol Manager (CTMS) Alternatives

OpenClinica is a premier provider of clinical data management software solutions. Offering powerful tools for efficient, compliant clinical trials, OpenClinica helps maximize the security, reliability, and compliance of every clinical research. Core products include OpenClinica Enterprise, OpenClinica Participate (helps capture data directly from study participants), and OpenClinica Randomize.

Medrio is on a mission to ease complexity in today’s hybrid, decentralized, and site-based clinical trials by delivering a flexible suite of eClinical technologies and services, including EDC, eCOA, ePRO, eConsent, Direct Data Capture, and Randomization and Trial Supply Management (RTSM). Trusted by CROs, sponsors, and sites across all therapeutic areas and trial phases from study startup and feasibility to post-market approval, we are industry-recognized for delivering eClinical software with intuitive interfaces and time-saving “drag and drop” configurations as well as high-touch customer engagement, onboarding, and support services. Medrio’s innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.

Longboat is a cloud-based clinical trial support solution provides users with an integrated Guided Compliance toolset to guide them at all times. Longboat provides the clinical trial site staff with the right resources to let them focus on patients. Longboat allows patients to view essential study information and check visit reminders. Longboat allows users to seamlessly manage the controlled rollout of the amended clinical trial protocol. Centralize the secure exchange of regulated documents between sponsors, CROs, and sites, significantly streamlining study startup and eliminating historically cumbersome processes across research stakeholders. All key stakeholders—clinical operations, monitors, site staff, and participants—access one integrated support platform with content tailored to meet their specific needs. Provide your site staff the tools and resources they need to stay engaged and compliant while focusing on the participant.

eDeviation supports all the operations for Protocol Deviation assessment and management. From software design and validation to collecting supporting documents and exporting data for the TMF, eDeviation® relieves your clinical team from the risks associated with missing or wrongly assessing one-time or recurring protocol deviations. eDeviation® is part of Ethical’s eClinical Software Platforms Solutions supporting faster and more accurate clinical trials management. Whether your protocol deviation assessments are performed by an independent expert committee or by your study team, our eDeviation® software is configured to exactly match your needs. Forms, workflows and exports altogether contribute to a GxP quality and effectively managed study. Study teams, Investigators’ Sites and Committee Members, when applicable, work seamlessly online in real-time to expedite judgments, consensus and timely completion of the protocol deviation assessments and management.

Electronic source documents – eSource – eliminates paper, standardizes and simplies workflow, and reduces errors and omissions. BREEZE eSource goes way beyond visit templates and scheduling. By synchronizing clinical contexts, regulatory and protocol requirements, with study procedures, BREEZE eSource ensures that users not only capture all protocol required data. BREEZE business rules make certain that the data collected are correct, complete, accurate, and compliant. Our dedicated team of clinical trial experts delivers custom, study-specific eSource documents for review and approval before study start-up and supports you throughout the trial and modifies them as needed. Modules seamlessly integrate and work together. Cross-Module Action Multiplier goes a step further by anticipating and completing automatically the additional tasks required by entries you make. For example, completing visits or procedures automatically posts to invoicing, recalculates scheduling, and more.

An integrated EDC, eConsent, ePRO and Virtual Visit platform for the efficient conduct of clinical trials. Replior is a company providing software for clinical trials. Our suite of systems is called Trial Online and enables collection and management of data from investigators, participants and wearables in an easy and efficient way. Trial Online supports decentralized clinical trials (DCT) by enabling the trials to operate with site visits, remote visits or as a hybrid. We started our journey 20 years ago with a request to build an online CRF service for one of the world’s largest pharma companies, back then we were an IT operations provider for the pharma industry. This was the starting point of providing software for collection of data in clinical trials. Today we offer a full suite of data collection software services, and our IT operation is performed by our, very certified, sister company Complior.

Using Interactive Response Technologies (IWRS), Clinion RTSM helps you with efficient patient randomization and clinical trial supply management The Randomization module of the Clinion RTSM Software allows you to implement simple to complex randomization strategies as per protocol specifications, fully integrated with Inventory. Clinion offers one of the most fully integrated EDC/RTSM platforms in the industry, so site users can perform Randomization and drug allotment, including returns and re-allotment, without having to log into two systems or worry about reconciliation Take advantage of our affordable and predictable pricing model to reduce the overall cost of RTSM ownership without sacrificing quality or functionality. Gain more by using our integrated EDC and RTSM modules

With eAdjudication® software managed service, trial leaders have control of timelines, the flexibility to adapt to changing conditions and outcomes, and the ability to monitor trends in provider performance and protocol conformity over the duration of long trials. Avoid hidden costs and timeline breaches in your Endpoint Adjudication Study with the innovative, all-inclusive, managed software service. The eAdjudication® Managed Software Service is the most efficient way for Endpoint Adjudication (CEC) Management. Working with the eAdjudication® platform and Ethical's Staff, study teams, committee members and clinical organizations interact effectively online in real-time in an user-friendly, and GxP-compliant environment, avoiding time-consuming, costly and error-prone manual processes. eAdjudication® all-inclusive services streamline the integration and adoption of EA software throughout eClinical organizations.

Innovate’s End-To-End Clinical Data Management Services. Our clinical data management processes, expertise and technology are developed to make each step of your clinical trial data management process more accurate and efficient for Phase I-IV in wide range of therapeutic areas. Our CDM Team Is Well-Versed With Current Good Clinical Data Management Practices (cGCDMP) International conference on harmonization Good Clinical Practices (ICH-GCP) 21 CFR Part 11 Compliance Health Insurance Portability and Accountability Act (HIPPA) Requirements Applicable Regulatory Guidelines SAS datasets SAS XPORT transport files EDC Helpdesk Support 24/7 On-Site and Off-Site Clinical Data Management Services Electronic Data integration and transfer Quality Control Activities Medical Dictionary for Regulatory Activities (MedDRA) Serious Adverse Event (SAE) Reconciliation Clinical Database Transfers Clinical Database Lock paper Case Report Form (pCRF) and electronic Case Report Form.

A Clinical Data Management System (CDMS), Clinical Trial Management System (CTMS) and Electronic Data Capture System (EDC) all in one powerful, integrated solution. All your study information can be at your fingertips with our innovative, flexible and compliant Clinical Trial Software System. Our servers or yours. Clindex® can be installed on your servers or it is available on the Fortress Medical Cloud (SaaS – Software as a Service). Cloud access is available world-wide and your data is securely stored at a SOC 3 certified data center. You can build, we can build. Clindex® provides all the tools you need to develop your own study database. Our quick start manuals and help documentation walk you through the process, step by step. Or our Clindex services team can develop a study for you.

Full cycle product for Research and Development teams in Pharmaceutical Industry. The product includes Electronic Trial Master File, Trial Management, Electronic Document Management with eSignature support. That is suitable for regulated areas as it is fully compliant with 21CFR Part 11 requirements. We develop and support systems from the very begining to the ready-to-use product using modern agile methodology and feedback given by clients. Satisfaction of customers needs is our main concern. We provide automation services of quality management systems starting from SOPs development and training to systems integration and business processes adapation. Our personnel have expertise in GCP, GLP, GCLP and also have been involved in many research organizations' audits and software development. By purchasing the system you get the full package of documents, training and support. So you can focus on your business and delegate us all the technical issues.

Premier clinical trial management system designed specifically to help overcome technical challenges associated with managing clinical trials. CTMS Master improves user accessibility and communication, reduces manual operations, and eliminates redundant data and tasks, allowing a more efficient trial conduct. An integrated Site Visit Report tool with automated workflow eliminates duplicate data entry and facilitates the creation of out-of-the-box Site Visit Reports (SVR). Maintain standard templates for project and site documents, events, milestones, site visit reports and budgets that are tailored as needed for each study. CTMS Master provides 100+ metrics/statistics for clinical study projects, countries and sites as well as 80+ standard reports plus ad hoc reporting capabilities. With CTMS Master, you can define site-specific budgets from a default budget template, track accrued payments and future obligations, define automatic or manual approval of each payment type, and more.

LifeSphere eTMF is your clinical trial’s single source of truth. Discover a versatile solution that streamlines inspections, ensures compliance, and saves your organization time and effort. Built as the first system to support the TMF reference model, LifeSphere eTMF aligns Clinical documentation with regulations and study protocols in one solution. Create and manage a single source of truth for your clinical trial. Ensure trial master file quality, timeliness, and completeness with live collaboration and real-time document sharing. Streamline TMF inspections quickly and efficiently to handle any audit. Maintain compliance with embedded workflows and dashboards that allow easy trial reconstruction.

From simple turnkey solutions to large-scale multi-site studies, we help PIs overcome common obstacles and limitations with their database setup and selection. Researchers also hire QuesGen to advise on data management best practices and provide additional services where needed to help studies get up and running more quickly. Experienced partner for dozens of academic institutions and researchers. Experienced in managing large data sets and running data curation through our flexible data platform. The ability to set up and scale research initiatives quickly and easily. With a comprehensive data model, assessments library, and curation expertise, QuesGen gets you up and running quickly, and ensures quality, compliant data, so you can focus on the analysis of the results. Support multiple clinical research initiatives across your institution using HIPAA and FDA 21 CFR Part 11 compliant solutions that can integrate with your EMR, FITBIR (Federal Interagency TBI Repository.

At ePharmaSolutions, we are building something new. We are not a high-tech company. We are an idea company whose thinking is highly entrenched in technology, but not limited by it. We support the drug development industry with solutions that improve the identification, activation, training and management of clinical trial sites. With new perspectives on old problems, we deliver technology-enabled solutions that help to “un-complicate” the chaos of clinical trial management. ePharmaSolutions (ePS) is a leading provider of e-clinical solutions that improve the way that clinical trial sites are selected, trained, activated, and managed. By applying fresh thinking to old problems, we deliver clever, technology-enabled solutions that empower sponsors, contract research organizations and investigator sites to “un-complicate” the chaos of clinical trial management.

SimpleCTMS was designed and developed to offer the benefits of a CTMS (Clinical Trial Management System) without the extensive upfront financial and resource commitments associated with traditional enterprise systems or the inherent inefficiencies of worksheet trackers. SimpleCTMS provides early-stage drug developers a scalable and cost-effective solution to improve the management, performance and study startup costs associated with clinical trials. A dedicated client manager provides pro-active support and guidance. All users receive technical support from our team of clinical software experts. Customized training and professional services are available at additional cost. Backed by a quality system using validated software processes.

DrugDev Spark™ is the world’s first comprehensive unified clinical operations suite. Explore our solutions below to learn why so many sponsors (including 9 of the top 10) and CROs (including 4 of the top 5) trust DrugDev technology. DrugDev Spark™ is the industry’s first comprehensive unified solutions platform – comprised of innovative technology and expert services proven to add value on thousands of clinical trials. From planning through closeout, our solutions are rigorously tested and improved by sponsors, CROs and sites of all sizes, in more than 60 countries. Through this experience, we have established and integrated best practices into every feature of our system. That’s why 9 of the top 10 pharma, 4 of the top 5 CROs, and the biggest industry collaborations are among the many organizations that trust DrugDev technology. Most of the world’s top sponsors and CROs are using DrugDev solutions to transform how they run clinical trials through collaboration.

OpenText™ Information Management solutions help life sciences organizations leverage insights from data and content to improve decision-making processes and accelerate product development. Integrate, manage, and securely exchange data across people, systems and things. Leverage information assets from R&D to commercialization. Freedom of choice with cloud-native software that can run anywhere. OpenText for life sciences accelerates the discovery process by extracting actionable insights that drive pipeline innovation. Capture and manage research papers into electronic lab notebooks with intelligent capture. Find insights with text mining. Extract knowledge trapped in the unstructured text contained in clinical trial reports, study protocols, clinical safety and efficiency findings. Find out how to intelligently analyze, classify and extract clinical trial documents to reduce the risk of costly stops and starts.

Complete control. Full visibility. LifeSphere CTMS is an easy-to-use trial management solution that helps clinical operations teams accelerate timelines, stay organized, and reduce complexity. Reduce study timelines with a modern, easy-to-use cloud application that streamlines study management and automates key activities across the trial lifecycle. Navigate complexity with a simple, yet powerful trial management application that provides full oversight of trial activities to keep study teams aligned and on time. Streamline your clinical environment with a turn-key platform for operations that includes payments and monitoring and delivers a seamless connection with LifeSphere eTMF. Create seamless connections with TMF Reference Model Exchange Mechanism Standard compliance for seamless, cross-platform document sharing.

In-system protocol & its a training program. Equipped with fingerprint attendance. Cronos provides highly customizable if/workflows capable for conducting derma/ patch/ other BA-BE/ early phase studies. Capture, cleanse and efficiently manage your study data from paper-based or EDC-based trials. Extract data in desired datasets following standards like CDISC (SDTM). EDC tool with real-time activities. It’s Bedside Data Collection capabilities help in paperless & faster assessments. It comes with a sample inventory & tracking facility as well. Compliance-ready data repository.The facility of data e-printing from almost all BA instruments/software and online review of data in defined workflow with e-stamping and e-signature.Project-wise view, export & archival of data. Generate high-quality statistical reports (tables, listings & formats) in fixed/desired formats with ease.

The constructive IWRS caters to well-organized, systematized drug supply between different investigation sites reducing drug wastage to a bare minimum as well as proactively handle complex randomization procedures for single arm and large multi-arm, multi-centered studies. SyMetric Platform with Dynamic Adaptive Randomization helps to avoid the imbalance of covariates across subjects, resulting in balanced Treatment Assignment irrespective of Sample Sizes. Patients Handling on SyMetric Platform provides Subject Screening and Enrollment, Visit Management, IP dispensing and receipt, Unblinding, Withdrawal and Completion tools to manage the Subjects effectively and efficiently. SyMetric Platform with robust IP supply management functionality allows drug supply managers to tightly control the supplies sent to Sites, adjust supply strategies for Sites based on the remaining treatment arms and new ratios.

Our platform offers the comprehensive support that your clinical trial needs using cutting-edge cloud-hosted technology. Clinibase will help your organization realize significant gains in efficiency and productivity. We do not adopt a plug-and-play approach with our Clinical Trial Management System. Why? Because we believe that every organization has unique systems and processes. Therefore, Clinibase can be fully customized to fulfill your organization’s clinical trial needs and requirements. Furthermore, we use surveys to troubleshoot, recognize areas for improvement, and automate all components of your daily clinical trial processes. Quickly locate eligible participants with our social integration tools to recruit them faster. Keep your participants engaged with smooth communication tracks that enable high retention and foster positive participant experiences. Enhance the validity of your trials knowing that data is recorded accurately and stored safely.

Unlimited trial duration, number of subjects, clinical sites, treatment arms and stratification variables, all for a one-time fee. Full support for double-blinded trials, including kit management, kit replacement and emergency unblinding. Randomize.net supports permuted blocked stratification, minimization and simple randomization algorithms. Configure randomization applications with the exact options and features you want. With Randomize.net's Web Service API, you can integrate randomization into your application. Full support for subject randomization and reporting available. Highly secure internet-based randomization service for clinical trials.

Mosio enables research teams to improve subject adherence, communications, and data collection on mobile’s most popular channel: text messaging. Our software makes research teams more efficient in how they communicate with study participants through messaging automation and interactive elements delivered to participant mobile phones. WHO WE HELP: + Clinical Trial Sponsors (Pharma and Biotech) + Cancer Centers and Clinical Research Organizations + NIH-Funded Studies + Public Health Agencies + Clinical Trial Managers, Clinical Operations Managers/Directors, Clinical Project Managers, Principal Investigators, Clinical Research (Study) Coordinators, and any research staff who communicate regularly with study participants. BENEFITS: + Interactive dosing reminders and medication adherence alerts. + Automate data collection. + Increase engagement and adherence. + Fix your no-show problem with SMS appointment reminders. + Improve retention with automated check-ins.

Available in multiple modalities, our market-leading solution for patient randomization and trial supply management is the most configurable and customizable Interactive Response Technology available. From Phase I through to IV, simple designs to complex adaptive trials, IXRS®3 will easily accommodate any permutation of study objectives, and with it comes a team of professional biostatisticians, language and integration experts who are at the ready 24/7. The site-facing functions are designed to automate steps that are prone to human error. Site users have the freedom to make data corrections without the need to call a Help Desk for support or fear of deviating from trial compliance. Easy-to-read visual tools instead of hundreds of pages of specifications and legalese. View and react to each stage of the software build along the way, eliminating delivery surprises.

The industry’s leading eSource, CTMS, and eRegulatory software for clinical trial sites. Capture source data seamlessly and in real-time with CRIO’s best-in-class electronic source. You’ll eliminate up to 90% of your paper and improve data quality by 80%. Take control of your operations with CRIO’s intuitive Clinical Trial Management System. Schedule patients, track financials, streamline recruiting, and more. Introducing electronic regulatory binders fit for the 21st century, which includes the first-ever electronic delegation log — all 21 CFR Part 11 compliant. For clinical trial sponsors: conduct 100% remote monitoring of your sites’ source data and regulatory documents in a secure, online portal. Join Our Network of 500+ Clinical Research Sites From Around The World. Our mission is to help you grow your business. We do that by streamlining your site’s operations, so that your studies don’t stop just because you aren’t in clinic.

Healthcare solutions from VACAVA reduce the complexity and cost of clinical trial regulatory document management. Each time documents move through a manual workflow, it introduces the opportunity for delays and lost information. VACAVA solutions help you streamline regulatory processes by storing profiles, forms and documents in a single easy-to-access online location. Documents seamlessly move through your workflow with approvals captured electronically (21 CFR Part 11 compliant). Easy-to-read dashboards enable efficient management. VACAVA’s Regulatory Document Management System was built in collaboration with a major clinical trial research base to simplify operations and radically increase efficiency. VACAVA’s Regulatory Document Management System is surprisingly affordable and can be customized to meet your unique needs. VACAVA’s solutions are flexible, scalable, and delivered via the cloud so you never have to worry about managing servers, security, and backups.

A simple and powerful CTMS for hospitals, site management organizations and small CROs with focus on budgeting, finance tracking and reporting. Clinicubes CTMS offers various types of useful special features that help companies successfully manage and conduct every aspect of the clinical trial. The centralized management of trial database provides the most actual information and allows better productivity. Aggregate, systematize and reorganize physicians and healthcare service institutions database. Collect, evaluate and analyze data from multiple studies and different locations on a single report. Provide with reporting options of how the trial is being carried out against pre-set criteria and targets. Communicate study performance data and other operational reports, through interactive dashboards.

AI-powered medical image analysis meets advanced clinical data process automation. Available as web-based SaaS or an on-premise solution, UNITY is trusted worldwide by major medical technology manufacturers and hospitals to collect complete, consistent, and compliant data. The integrated modules for PROM, eCRF, and medical image analysis streamline key data collection activities to enable faster, cost-efficient trials. RAYLYTIC's Imaging Core Lab possesses decades of experience in the high-precision, automated, independent evaluation of musculoskeletal morphology and device performance in spine, hip, and knee to offer clients unparalleled analytic and operational support.

Datatrak International, Inc. is a software-as-a-service provider of enterprise cloud-based technologies for the life sciences industry. Datatrak’s unified eClinical solutions and related services help improve cost and time efficiencies for the clinical trials industry. Datatrak built its multi-component, comprehensive solution on a single, unified platform and expanded this concept to include services delivery via Datatrak’s Clinical and Consulting Services group. The Company delivers a complete portfolio of software products designed to accelerate the reporting of clinical research data from sites to sponsors and ultimately regulatory authorities, faster and more efficiently than loosely integrated technologies. Our commitment is to empower workgroup teams with role-based access to version-controlled file management, calendar events, tasks and contacts, all built within our eClinical applications including EDC, CTMS, reporting, data analytics and business intelligence.

Over the last several years, the Life Sciences industry has faced nearly $15 billion in fines and compliance-related settlements, making it critical for companies to adhere to pharmaceutical, medical device and biotech best practices. Efficient and effective management of clinical trials can also significantly impact the time, scope and budget for the development of a drug or medical device. With OpenText™ Clinical Trial Quality Management System (ctQMS), companies can remain compliant, reduce costs of records management and establish best practice through collaboration before, during and after the clinical trial lifecycle.

TCS ADD platform accelerates speed-to-market for pharmaceutical industry across the entire clinical R&D value chain and helps make clinical trials more agile and safe. TCS ADD enables digital ecosystems, simplifies data complexity and provides faster access to new and effective drugs for the patients. The platform is powered by cognitive artificial intelligence engine called TCS Decision FabricTM, smart analytics and IoT that provides superior business value to pharmaceutical industry. A next-generation and end-to-end metadata-driven solution to manage industry & sponsor clinical standards. A data science-driven platform that leverages AI & ML technologies to enable quicker decisions, faster study start-up and targeted interventions. A solution that digitizes the entire clinical trial supply management process while putting the patient in the center, increasing patient’s safety and overall efficacy.

Cloudbyz eTMF solution offers a cloud-based repository of all clinical trial documents including files, images, information, etc. Digitally store, manage, and share all clinical trial-related documents with a centralized overview. Manage essential trial documents, stay inspection ready, and enable real-time visibility for CROs, sponsors, monitors, and other stakeholders in a clinical trial. Cloudbyz eTMF is built on the cloud, enabling Sponsors, CROs, and Sites to manage their trial documents with the highest levels of efficiency and integrity. The solution benefits are listed below - 1. Secure, reliable & scalable 2. Compliant & inspection ready 3. Flexible & easy to use 4. Real-time visibility of TMF completeness 5. Collaboration with Site/ Sponsor/CRO

Korio is the Randomization & Trial Supply Management (RTSM) platform designed for flexibility, quality, and speed. Not just built to tackle clinical trial challenges as they come, but built to prevent them in the first place. No matter what trials you may face, Korio is prepared to handle them. Legacy RTSM systems are not built to support the trend toward increasingly complex study designs. Brittle RTSM platforms do not easily accommodate on-the-fly RTSM design updates to match clinical trial changes. Inspired by decades of hands-on experience. The result is an RTSM platform where flexibility meets reliability, and modernity meets experience. Streamline your user experience with Korio's intuitive, role-based interface. From site users and supply managers to clinical operations and data managers, empower everyone to work faster and take action with confidence. Experience consistent management of your trial.

The Medidata Clinical Cloud is our cutting-edge platform that transforms the clinical trial experience for patients, sponsors, CROs, and research sites. As the only unified technology platform dedicated to clinical research, the Medidata clinical cloud addresses the holistic research process from start to finish. Our platform helps life science and medical device organizations cut development costs, mitigate risks, and deliver treatments and devices to market faster. No matter which products you choose for your clinical trial program, you will have access to the power of the Medidata Clinical Cloud. At Medidata, we’re leading the digital transformation of clinical research. Powered by artificial intelligence, machine learning and advanced analytics, our platform brings researchers, study managers, investigators, and patients together to accelerate research. Obtain regulatory-compliant, patient-friendly electronic informed consent for clinical trials.

As a Data Management provider we offer data management and statistical analysis planning and model development with applicable CRF design. All the appropriate documentation is provided by us according to FDA and other regulations. Previous experience has shown us that putting more effort into the planning phase will give a better, faster and efficient result in the end-phase of the trial. Our databases are generated by experienced data managers who have worked with several eCRF-s and already know the critical parts of the electronic data capture system design and data collection. This allows the eCRF to be built in a short period of time. eCRF validation and testing is compulsory part of the design and is dealt by different personnel in order to receive a hundred-percent elaborated eCRF.

Teckro clinical trial software connects all study stakeholders to critical information. Every time. Everywhere. We find answers every day from our smartphones. Why shouldn’t the same be true for clinical trials? Critical, up-to-date study information always at hand when and where research staff and CRAs need it. Study answers are just a tap away on any mobile device, giving research staff a direct line to crucial details. And when updates or amendments are needed, site staff and monitors can be alerted in real-time. Cloud-based clinical trial software, Teckro is up and running quickly with nothing to install. It’s simple, easy and intuitive. Teckro is securely hosted and compliant with major industry regulations, including FDA 21 CFR Part 11. Only the right, approved version of study documents, means no more worrying about version management.

Get on the path to cleaner data and confident decisions with Clinical Ink. As the pioneers in eSource, Clinical Ink’s technology platform and delivery capabilities provide greater certainty from source to submission. Explore Lunexis™, a clear and connected eSource Ecosystem that delivers purpose-built data capture solutions for your protocol at the critical moments that matter. The Lunexis platform makes it easy to deploy an integrated, convenient eSource solution that provides anytime, anywhere access to your study data. We deliver more than fast, clean data — we deliver confidence. Not only are your sites and patients assured of an easier experience, but you can be certain that your patients are more compliant and engaged and that your protocol is executed correctly. Start your most complex studies with confidence — implement Lunexis to support well-informed, optimal decisions.

Ofni Clinical is a clinical data management tool that rapidly creates and implements secure, regulatory compliant clinical trial databases. Ofni Clinical includes comprehensive search and report features, has strong data validation and edit check options, contains flexible customization tools, and can be implemented quickly and economically. The databases can be used to capture data from existing paper Case Report Forms or as paperless electronic data capture systems. Many Ofni Clinical projects require less than a month to go from project initiation to validated implementation. Contact us today and find out how to use Ofni Clinical for your clinical trials. Matches your existing Case Report Forms (CRFs), reducing training and implementation costs while adding electronic data capture and review capabilities. Includes extensive edit check and data validation features to identify questionable data entry and support data analysis.

Compared to other EDC solutions on the market from MediData, DataTrack, Omnicomm and others, TrialStat is the most all-encompassing suite of study management tools that can be seamlessly connected to external data sources such as EMR, wearables, and other clinical and non-clinical data and information sources. TrialStat offers a fully unified platform suitable for all phases and types of trials. Our single-sign-on, multi-tenant EDC suite includes modules for Randomization, Adjudication, Coding, Safety, Patient Diaries/ePRO, Vendor Neutral Imaging Archive, a robust Reporting and Analytics Portal and custom Machine Learning programs. With a focus on data analytics, TrialStat offers real-time reporting, data extracts on demand, and analytics across a single study, a program, or your entire research portfolio – providing all stakeholders relevant, customized, timely insight into all aspects of study data and highlighting areas of risk or potential delays.

DSG, Inc. is a leading global eClinical provider with a fully unified suite of innovative technology solutions and data management services for the global clinical research community. DSG's eClinical software platform provides competitive advantage that is cost-effective with on-time project delivery. DSG solutions have been used in thousands of clinical trials around the globe with our award-winning eCaseLink™ platform and eCaseLink Designer for enterprise licensing. Founded in 1992, the company is proud to be recognized as the first provider of a fully integrated EDC and IRT Randomization and Trial Supply Management system with the SCDM Data Driven Innovation Award.

Ennov CTMS facilitates the end-to-end management of clinical trials. The software allows sponsors to be more efficient, to make better decisions, to ensure compliance, to select investigators well, to monitor patient recruitment and to manage finances. Ennov CTMS includes comprehensive directories to manage site personnel (investigators, sub-investigators, study coordinators, pharmacists) and organizations (hospitals, competent authorities, CROs, suppliers). Ennov CTMS provides functions for tracking patients, patient visits, EDC data, activities, queries, deviations, adverse events, drug supply, monitoring visits and finances. A full complement of reports and dashboards provide total visibility into the status of each study, country, site and investigator to provide the information necessary to make the best decisions possible. - Comprehensive CTMS software - Integrated with Ennov Clinical Data Management - Clear visibility into investigational sites - Integrated workflow

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate® Clinical Data Cloud — the foundation of digital trials. Leveraged by 100+ biopharmaceutical companies, elluminate is a purpose-built clinical data platform designed to accelerate digitization efforts in order to proactively manage the exponential growth of clinical data volume, variety, and velocity. According to Gartner’s 2022 Hype Cycle for Life Science Clinical Development, life science companies continue to accelerate scaling digital capabilities and the adoption of hyperautomation, AI and advanced analytics is becoming mainstream. With elluminate’s automated data pipeline and scalable infrastructure organizations are able to keep up with the complexities of modern clinical trials to deliver business value across clinical development functions.

Phoenix CTMS is a modern web application combining the capabilities of database software used in clinical research in one modular system. After years of collaborative development with trial sites at the Medical University of Graz, the Phoenix CTMS now becomes publicly available (LGPL 2.1). This unmatched feature set is geared to support all operational and regulatory requirements of the clinical front end in academic research, at CROs (Contract Research Organisations) and hospitals conducting clinical studies of any phase. want a CDMS that gives you unlimited Javascript form scripting support (server- and browserside). You need to deal with large eCRFs (electronic case report forms) want to try a serious open source alternative for eCRFs. Need to formulate complex ad-hoc database queries to list matching subject candidates using set operations. Conduct several trials in parallel and need to organize site staff and resources. Need a software to implement various processes for ICH GCP.

IBM® Clinical Development provides pharmaceutical, contract research organizations and medical device companies unified technology from start up to submission to support clinical trials. With our clinical data management system, users can organize and analyze report data from anywhere in the world. Enabling pharmaceutical organizations to deliver therapies faster to their patients. Design and launch studies without database migration. Deliver quick and easy remote consent with minimal integration.

Actionable insights, driven by the industry's #1 AI-powered clinical analytics platform, enable your teams to manage risk and improve performance across studies, systems, sites, and vendors. State-of-the-art clintech from Saama is designed to streamline your workflows, automate time-consuming processes, and improve collaboration across clinical operations, medical review, data management, biostatistics, and pharmacovigilance. Sponsors and CROs rely on Saama for data aggregation and artificial intelligence solutions that lead to better decision-making, eliminate delays, and significantly shrink drug development costs and timelines. Saama can put you on the fast track to clinical trial process innovation. When all your clinical data is in one place and updated in real time, life’s much easier for your ClinOps and medical review teams. Data Managers have been underappreciated for too long. Eliminate manual work so they can pay attention to the data points that matter.

Streamline regulatory operations across your organization to improve compliance and advance research. Veeva SiteVault reduces the complexity of conducting clinical trials by connecting your regulatory operations to improve efficiency and compliance. Manage regulatory and source documents in a single system that supports 21 CFR Part 11 and HIPAA requirements. With a real-time visibility across trials, SiteVault Enterprise improves operational efficiency, speeds study activation, and enables faster, higher-quality trial execution. Replace manual processes and design your own workflows to support quality and speed study activation. Eliminate the need to grant EMR access or redact documents by providing monitors with secure, direct access to your regulatory and source documents. Create your own workflows, reports, and dashboards for greater visibility into start-up timelines and regulatory processes.

Clario CTMS is an intuitive end-to-end clinical trials management solution that brings control, efficiency for both data flow and workflow, and quality data to every study, yielding cost savings in time, labor and operational expenses. This web-based CTMS works on the go, letting you view and manage real-time operational performance — wherever and whenever. With the Microsoft Office-based work environment, Clario CTMS transforms a disjointed clinical trial into an efficient and cohesive work environment using the most widely used office productivity tools in the world. Bi-directional information exchange from Clario CTMS to SharePoint and other Microsoft products is seamless, making for a powerful, high-performance solution. Moreover, integrating Office processes with clinical operations can reduce back-office paperwork, significantly lower administrative overhead and result in low total cost of ownership.

Intrinsic’s clinical trial management system (Intrinsic’s CTMS®) has been designed with the end user in mind - minimizing data entry and focusing on proactive study management. Cloud-based, with a streamlined interface, the ability to manage studies at any level, and a task-based design, Intrinsic ushers in a new era of trial management tools. Intrinsic® is the world’s first CTMS built with native integration with all Microsoft applications, including Outlook, Excel, SharePoint, and Power BI. With Dynamic Worksheets, users can quickly import bulk data and study updates from CROs (using the CRO clinical trial management software), without the need to integrate systems, as well as create ‘live’ exports for ad-hoc analysis and reporting. Intrinsic CTMS® also leverages Power BI, a cloud-based reporting tool, which enables users to report on data from other clinical systems, such as EDC and IRT, with having to build costly data warehouses.

One Platform to Research, Document, and Collate your Clinical Data. Simplify your research data with the Nucleus platform. A single platform to store your study documentation, clinical datasets, submission data and compliant media. Nucleus Documents enables document management and version control for your quality documentation and media. Control, manage, and share company content with ease. Collate and control your electronic trial master file documents with ease using our centralized regulatory document management solution. Nucleus Coding enables dictionary term coding against both MedDRA and WHODrug dictionaries, either in our standalone application, or integrated into your data capture system.