Alternatives to Protocol Manager (CTMS)
Compare Protocol Manager (CTMS) alternatives for your business or organization using the curated list below. SourceForge ranks the best alternatives to Protocol Manager (CTMS) in 2026. Compare features, ratings, user reviews, pricing, and more from Protocol Manager (CTMS) competitors and alternatives in order to make an informed decision for your business.
-
1
Medrio
Medrio
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. -
2
ClinCapture
ClinCapture
At ClinCapture our mission is to build software that saves lives. Our technology lowers the cost of clinical trials by streamlining data capture processes while providing a platform that protects patient privacy. Clincapture advances the evaluation and development of drugs, biologics, and devices that demonstrate promise for the diagnosis and/or treatment of a wide range of diseases or medical conditions. -
3
Castor EDC
Castor
Castor is a leading platform for clinical data management, offering advanced solutions for electronic data capture (EDC), patient-reported outcomes (ePRO), and eConsent. Designed to streamline clinical trials, Castor enables researchers to efficiently collect and manage data from multiple sources in a compliant, user-friendly environment. The platform also supports decentralized trials (DCTs), providing tools for remote patient recruitment, monitoring, and real-time data analysis. Castor is trusted by over 50,000 users globally, helping clinical research teams accelerate trials while ensuring high-quality data and regulatory compliance.Starting Price: $100.00/year -
4
Longboat
Advarra
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. -
5
eDeviation
eDeviation
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. -
6
BREEZE CTMS
BREEZE CTMS
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. -
7
Cytel
Cytel
Cytel is a leading global provider of clinical trial design software, biometric services, and advanced analytics, specializing in optimizing clinical trials and assisting pharmaceutical companies in unlocking the full potential of their clinical and real-world data. Founded in 1987 by distinguished statisticians Cyrus Mehta and Nitin Patel, Cytel has been at the forefront of adaptive clinical trial technology and biostatistical science. Our software solutions, including the East Horizon platform, empower precise trial design and simulation, utilizing adaptive and Bayesian tools to optimize protocols and accelerate drug development. The East Horizon platform integrates key components of Cytel's trusted software portfolio into a unified solution with R integration, enhancing trial design capabilities. Additionally, Cytel offers the Xact software suite, a comprehensive toolkit for statistical analyses of small datasets, and sparse, and missing data. -
8
Biorce Aika
Biorce
Biorce’s Aika is an AI-native clinical intelligence platform that accelerates every stage of the clinical trial lifecycle by replacing slow, manual protocol development and feasibility assessment with explainable, evidence-based automation. Built on insights from around one million real global trials, it generates first-draft study protocols, complete regulatory documentation, site feasibility assessments, risk and data management plans, and other essential trial artifacts in a fraction of the time traditional methods require, helping reduce delays and costly amendments. Aika provides full transparency into how it reaches recommendations so teams can confidently present choices to regulators and maintain expert control, blending AI speed with clinical expertise. It minimizes trial preparation timelines from weeks to days, cuts the number of amendments, and lowers overall risk while integrating seamlessly into existing workflows without heavy retraining. -
9
LifeSphere eTMF
ArisGlobal
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. -
10
TrialKit
Crucial Data Solutions
TrialKit is a unified eClinical platform designed to support the full lifecycle of clinical trials, from study design through data analysis. Built for sponsors, CROs, and research sites, TrialKit combines EDC, ePRO/eCOA, eConsent, RTSM, medical coding, imaging, and more in a single configurable system. Its drag-and-drop study builder enables rapid setup of compliant studies without programming, while web and native mobile apps support secure, real-time data capture from any location. TrialKit AI extends the platform with advanced analytics, study simulation, and protocol validation, helping teams evaluate design decisions and identify risks earlier. With API-based integrations and support for global compliance standards, TrialKit reduces system fragmentation, improves efficiency, and provides a scalable foundation for modern clinical research. -
11
Folio3 Clinical Trial Management
Folio3 Digital Health
Folio3 Digital Health's Clinical Trial Management Software (CTMS) is a comprehensive, web-based platform designed to streamline the entire clinical trial lifecycle for pharmaceutical companies, CROs, and research organizations. It centralizes trial operations, from planning and site management to data collection and reporting, ensuring compliance with global regulations like FDA 21 CFR Part 11, GxP, and HIPAA. The software emphasizes user-friendly interfaces, real-time dashboards, and scalable modules to handle trials of any size efficiently. Core Modules The platform features dedicated modules for study setup, where users define protocols, timelines, and budgets with customizable templates. Site management tools track investigator qualifications, contracts, and payments, while patient recruitment capabilities include screening, enrollment tracking, and visit scheduling with automated reminders.Starting Price: $300 -
12
eReconciliation
Ethical
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. -
13
Clinion RTSM
Clinion
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 -
14
Transition Technologies eCRF
Transition Technologies Science Sp. z o.o.
Flexible eCRF platform for non-commercial clinical trials, configurable to any clinical trial study protocol. Our eCRF solution was created on the basis of many years of experience of researchers and medical teams with whom we carried out research projects. The system is, above all, easy to use, user-friendly and extremely flexible. The prepared solution meets all the required quality standards, and thanks to the full control over the code, we can further develop and adapt it to the changing requirements of regulators and the clinical trials market.Starting Price: $45k licence -
15
Trials.ai
Trials.AI
Our Smart Protocol system aims to automate and add intelligence to clinical trial design with AI. Our Smart Protocol solution is revolutionizing the manual way research teams design clinical trials. In the digital age, humans cannot physically read and digest every bit of information relevant to a given decision. In addition, almost every company has valuable data that is not being used - more often than not, documents are living in repositories with no line of sight. As a result, companies life science companies are making important and costly decisions with incomplete information. We aim to take companies like yours from a document-driven environment into a data-driven one. We are reimagining how clinical trials are researched and planned by removing the barriers between data and end-users. We do this by mining massive amounts of trial-related documents from both customers and the public domain— so you don’t have to.Starting Price: $20 per month -
16
TrialPoint
Databean
TrialPoint™ electronic data capture (EDC) is easy to configure, easy to use, and the coordinators love it. Our data managers are experts in converting clinical protocols into geek-speak (metadata dictionaries for those in the know) and will configure TrialPoint™ to work for you, not against you. The system can accept any randomization string, media upload, or coding dictionary. It can even blind users to treatment assignments. To promote time-sensitive data collection. the system will prospectively calculate visit windows and send out alerts and reminders keeping the team focused and on task. Nowadays, patient-reported health outcomes and quality of life questionnaires are included in most trial designs and are responsible for many protocol compliance issues. Take a look at TrialPoint’s electronic patient-reported outcomes (ePRO) module which can be configured to fit any quality of life questionnaire or patient diary. -
17
cubeCDMS
CRScube
cubeCDMS is an electronic data capture solution designed for clinical trial operations that streamlines the end-to-end data collection and management workflow. The system supports full data-management workflows including automatic protocol-violation detection, batch query management and native risk-based monitoring to help improve data quality and operational efficiency. The intuitive, no-code user interface enables study teams to build eCRFs (electronic case report forms) from a library of more than 55 ready-to-use forms and edit checks, quickly set up the database, and reduce start-up time. Designed for usability, cubeCDMS allows data entry once and flows data seamlessly across other integrated CRScube modules, reducing redundancy and reconciliation. Additional benefits include AI-powered medical-coding support, drag-and-drop form builders, multi-language support, and robust audit trails and change-history tracking. -
18
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.
-
19
ePharmaSolutions
ePharmaSolutions
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. -
20
OpenText for Life Sciences
OpenText
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. -
21
LARVOL CLIN
LARVOL
The LARVOL CLIN platform delivers comprehensive, AI-powered data intelligence and analytics tailored for oncology and drug-development professionals by aggregating more than 100,000 cancer clinical trials along with detailed results, digitized Kaplan-Meier curves and forest plots, and real-time social-media reactions from over 5,000 oncologists. Users can search by condition, intervention, or trial ID within a single streamlined interface offering expert-curated insights and visual dashboards for data-driven decision-making. The system also covers conference tracking, biomarker and diagnostics databases, and market-intelligence reports from over 25,000 sources, including regulatory communications, clinical-trial registries, and scientific congresses. Built to support pharma and biotech teams in understanding trial outcomes, trends, mechanisms of action, biomarkers, and disease pipelines, the platform integrates deep search filters, heat-maps, real-time alerts, and more. -
22
DrugDev Spark
IQVIA
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. -
23
Simple Trial
Trial by Fire
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.Starting Price: $399 per month -
24
Clin'form
Kayentis
Clin'form is a flexible, robust, and comprehensive electronic Clinical Outcome Assessment (eCOA) platform designed to streamline clinical trials for patients and sites, enhance data quality, and accelerate processes for research teams. It is adaptable to all protocols and populations, effective for any type of questionnaire (PRO, ObsRO, ClinRO, Diary), and caters to all age groups, from pediatric to older patients. The platform accommodates any population size, capable of managing studies ranging from a handful to over 10,000 patients across all geographic regions. Clin'form offers seamless integration with other clinical systems, ensuring a smooth workflow, and supports flexible data collection modes, including provisioned tablets or smartphones, the patient's own smartphone, web access from any browser, and interviews. Key features include an embedded tele-visit feature to plan for the unplanned, patient engagement modules to ensure high patient compliance. -
25
BizNet
Sarjen Systems Pvt Ltd
Built for the evolving needs of pharmaceutical, biotech, and CRO organisations, our AI-enabled Clinical Research Platform unifies Early Phase CTMS, Late Phase CTMS, and Bioanalytical LIMS into a single, GxP-compliant ecosystem. It streamlines the entire clinical development lifecycle, from volunteer and patient management, study execution, sample tracking, and bioanalytical workflows to data review, reporting, and regulatory compliance. Powered by AI-driven automation, predictive insights, intelligent workflow orchestration, and real-time analytics, the platform enhances data integrity, accelerates decision-making, minimizes manual effort, and improves operational efficiency. With seamless system integration, audit-ready processes, and support for global regulatory standards such as 21 CFR Part 11, GLP, GCP, and GxP, it enables faster, scalable, and compliance-driven clinical trials with superior quality and patient-centric outcomes.Starting Price: $79 -
26
Zelta
Merative
Zelta is a cloud-based unified clinical data management and acquisition platform with adaptable modules that can be tailored to meet the unique needs of your clinical trials program and accelerate outcomes. It offers features such as electronic data capture, clinical operations tools like randomization and trial supply management, clinical trial management system, electronic trial master file, and patient and provider engagement solutions including electronic clinical outcome assessments and electronic consent. Zelta is designed to manage clinical studies across all phases, therapeutic areas, and regions, providing a user-friendly interface and seamless access through single sign-on from anywhere in the world. The platform emphasizes flexibility and scalability, allowing for customization to align with specific study goals and the integration of solutions from both Zelta and other technology vendors. -
27
Signant Health
Signant Health
Signant Health is a global evidence-generation company that helps modernize clinical trials by meeting patients where they are and reimagining the path to proof. They offer comprehensive clinical technology solutions, including electronic Clinical Outcome Assessments (eCOA), Electronic Data Capture (EDC), electronic clinician ratings, and a unified eClinical platform. Their patient engagement tools encompass a patient engagement app, eConsent, and telemedicine capabilities. Signant Health also provides clinical data and analytics services, such as COA data analytics and data aggregation and intelligence. With over 30 years of experience, they have supported thousands of trials and contributed to hundreds of drug approvals, making them a trusted partner for sponsors and CROs aiming to deliver high-quality data for trial decisions and regulatory submissions. -
28
Phoenix CTMS
Phoenix CTMS
Phoenix CTMS is an integrated, web-based platform combining Patient Recruitment System (PRS), Clinical Trial Management System (CTMS), and Clinical Data Management System (CDMS) functionalities into one modular, free-to-use application. Designed to meet the operational and regulatory needs of clinical research, it supports academic institutions, CROs, and hospitals conducting trials of any phase. The system offers private, encrypted subject registries to safeguard personally identifiable information and complies with EU-GDPR requirements. Phoenix CTMS includes advanced electronic data capture (EDC) features with unlimited JavaScript form scripting and support for large electronic case report forms (eCRFs). It enables managing multiple trials simultaneously with tools for site staff and resource organization. Developed collaboratively with the Medical University of Graz, Phoenix CTMS is a secure, open source alternative to traditional EDC packages.Starting Price: $1 one-time payment -
29
Suvoda
Suvoda
Suvoda is a global clinical trial technology company specializing in complex, life-sustaining studies in therapeutic areas such as oncology, central nervous system disorders, and rare diseases. Founded in 2013, Suvoda offers an integrated platform that includes Interactive Response Technology (IRT), electronic Consent (eConsent), electronic Clinical Outcome Assessments (eCOA), and ePatient solutions, all designed to manage critical patient interactions efficiently. Their patented software architecture ensures a seamless user experience, facilitating precise randomization, drug supply management, and real-time data collection. Committed to enhancing patient comprehension and reducing site burdens, Suvoda's solutions are built to adapt to the evolving complexities of clinical trials. Headquartered near Philadelphia, with offices in Europe and Asia, Suvoda has supported over 1,500 trials across more than 85 countries. -
30
Replior
Replior
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. -
31
LifeSphere CTMS
ArisGlobal
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. -
32
Cronos
Webosphere
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. -
33
CIMS Global
CIMS Global
CIMS Global provides regulated data science platforms and eClinical solutions designed to reshape the future of clinical trials by improving the quality, efficiency, and speed of clinical trial data acquisition, processing, analysis, monitoring, and regulatory submission. Its suite includes innovative solutions such as CRE, DDM, DMC-HUB, and eBinder, along with an eClinical Suite that supports data collection, analytics, and clinical applications across every step of a trial. CRE is a multi-tenant, validated Statistical Computing Environment for compliant clinical data analysis, using R, RShiny, and the RStudio IDE within a secure, audit-ready framework that meets 21 CFR Part 11 and GxP standards. DDM is a patented Dynamic Data Monitoring platform that displays cumulative treatment effect on a trial radar screen and predicts a clinical trial’s chance of success or failure. -
34
assisTek
assisTek
AssisTek is a leader in innovative clinical technology solutions for clinical research, offering custom clinical software solutions to streamline and enhance patient data collection. With over 25 years of excellence, they have supported more than 800 clinical research trials across 46 therapeutic areas, including over 500 multinational Phase I–IV clinical trials. Their eCOA solutions are highly scalable, customizable, and efficient, powered by a proven, cloud-based technology platform. AssisTek's product suite includes TEK eCOA Tablet, designed to support any questionnaire used in a clinical trial, TEK eDiary for capturing patient-reported outcomes at home, TEK Configurator for building clinical trial projects from start to finish, and TEK Study Portal for eClinical tracking, training, and reports in one place. Their systems and services have made them the top choice for collection and analytics among patients and clinicians. -
35
PRA Prism
Nextrials
Data comes at you from all directions – EDC, EHR, smartphones, mobile devices, central laboratories. Prism assimilates data from these disparate sources and transmutes them into information and ultimately knowledge. Prism EDC combines ease-of-use with innovative features to provide a fresh solution for the collection and management of clinical trial data. Prism offers more that than form-based data collection, it aggregates and manages data from a myriad of data sources. Prism eSource is an innovative software solution that allows research teams to extract clinical trial information directly from a site’s electronic health record (EHR). This creates efficiencies and cost savings beyond the current paradigm where sites must enter the same data in multiple systems and accelerates the delivery of novel therapies to patients. -
36
Oracle Clinical One
Oracle
Clinical One RTSM can support a randomization strategy for the simplest to the most complex studies without the need for programming or coding, which eliminates the need for prolonged user acceptance testing. Take control of your study through self-service configurations and build a study in days instead of weeks. Assess the status of the drug inventory and make modifications in real-time without reverting to the vendor and incurring cost and change requests. Eliminate change request costs and avoid delays by quickly implementing changes and promoting your studies in seconds. The only platform that truly unifies people, processes, and data to simplify and accelerate the clinical trials of the future. Virtual components in clinical trials allow greater patient participation and significantly improve clinical trial data quality. Transformative digital strategies are needed for faster study startup to harmonize data from any source and to streamline workflow. -
37
ez-SourceDocx
Alpha Clinical Systems
Maximize data quality. Ensure data quality by capturing eSource data directly during the patient visit. With built-in edit and validation checks, users capture high-quality data electronically, dramatically reducing errors and queries—and delivering data for real-time, remote monitoring. Reduce study time, cost and risk. Promoted and endorsed by the FDA to streamline and modernize clinical trials, purpose-built eSource eliminates slow, error-prone and inefficient SDV and transcription into EDC systems. Streamline site, study efficiency. Designed with site users in mind, ez-SourceDocx streamlines workflows, reduces workload and ensures protocol execution by guiding sites through properly sequenced visit procedures that guarantee all end point data and prompt quality investigator evaluation. -
38
Improve productivity by streamlining, automating, and reporting on clinical trial operations data across all study management processes. Siebel CTMS is a comprehensive, scalable, integrated trial management suite that improves operational efficiency by standardizing clinical operations workflows and providing real-time visibility to data. Siebel CTMS provides trial management capabilities that help you manage and monitor trial operations from start to finish. Siebel CTMS improves data quality with workflows that can be configured to meet individual customer processes for all research studies. Siebel CTMS can be integrated with advanced analytics capabilities that provide you with timely, fact-based insight into clinical programs to drive informed business decisions. Get real-time access to complete and trustworthy clinical trial data so you can make better decisions quickly, effectively, and easily.
-
39
QureClinical
Quretec
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. -
40
Clinical Ink
Clinical Ink
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. -
41
TrialStat
TrialStat Solutions
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. -
42
Science 37
Science 37
Science 37 is a clinical research company specializing in decentralized clinical trials through its Metasite model, which eliminates physical proximity as a barrier, enabling patients to participate from anywhere. This approach expands access to over 90% of patients who are unable to participate in traditional site-based research, offering the recruiting power of 20 sites in one and providing the flexibility patients need to participate from anywhere. The Metasite is powered by a proprietary platform that drives uniform study orchestration, guiding the workflow of patients and study staff, and capturing study data without the need for manual reentry. This centralization of people, processes, and platforms delivers built-in protocol compliance, ensuring greater compliance and high-quality data. Science 37's in-house medical teams, telemedicine investigators, and mobile nurses have extensive experience in remote trial conduct across various therapeutic areas, ensuring broad reach. -
43
SyMetric
SyMetric Systems
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. -
44
Randomize.net
Interrand
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.Starting Price: $2,500 one-time payment -
45
TCS ADD
Tata Consultancy Services
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. -
46
Cloudbyz eTMF
Cloudbyz
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 -
47
ClinSoft
Innovate Research
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 (HIPAA) 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. -
48
nQuery
Statistical Solutions
From sample size and power analysis to adaptive trial design, discover the nQuery difference today. The complete trial design platform to make clinical trials faster, less costly & more successful. See why nQuery is the #1 choice for researchers and Biostatisticians worldwide who need to tackle increasing trial complexity, spiraling costs and changing regulations. Calculate sample size for FDA/EMA submission. Fast spreadsheet-style interface with no coding required. Solutions for Frequentist and Fixed-term trials. Easy to use reporting for all trial stakeholders. Provide realistic estimates of expected timings and costs. Align your sample size with scientific & budgetary requirements. Fine-tune calculations with the specify multiple factors tool. 1000+ sample size and power calculation procedures. Rapidly calculate sample size for a multitude of scenarios -
49
CTMS Master
Anju Software
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. -
50
HEKMA
HEKMA
HEKMA is an AI-powered clinical trial intelligence company focused on accelerating clinical research by improving patient recruitment, trial feasibility, and patient engagement. The company serves CROs, pharmaceutical sponsors, hospitals, and patients through an integrated platform that connects electronic health records (EHRs), AI-driven trial matching, clinical trial management, and patient engagement tools. Its mission is to reduce enrollment delays, improve access to clinical trials; particularly for underserved populations and make clinical research more efficient, transparent, and patient-centric. HEKMA combines expertise in healthcare, artificial intelligence, and clinical operations while maintaining compliance with industry standards such as HIPAA, 21 CFR Part 11, GDPR, and HL7/FHIR.
