21 Best Clinical Trial Management Software for 2025

Even before COVID-19 was officially declared a pandemic, clinical trials and research have already been dealing with numerous challenges. These include regulatory mandates, access to patients, managing finances, and the overall complexity of trial designs. While improvements have definitely been implemented in an attempt to simplify the clinical trial process, including the use of laboratory software, its fragmented structure continues to create more loopholes that make clinical trials unnecessarily challenging (Krofah et al., 2021).

This is where clinical trial management software, or CTMS, comes to play a significant role in bringing together the critical components of clinical trials and research, especially in this day and age when remote processes are being utilized more and more in clinical trials. In the list below, we gathered 20 of the best clinical trial management system vendors designed to streamline, speed up, and improve the decision-making process of clinical trial and research operations.

For years, clinical trial sponsors have relentlessly pursued new avenues to make clinical trials faster and more convenient to patients and physicians with the help of new technology. Come 2020, the COVID-19 crisis has largely contributed to the accelerated adoption of decentralized clinical trial components, which reshape both the  clinical trial environment and experience. Here are some of the relevant statistics that attest to the impact of modern technology on today’s clinical trials:

• As of June 2022, 32% of registered clinical trial studies are located in the United States (ClinicalTrials.gov, 2022).
• 57% of clinical trial investigators interacted virtually with patients during the peak of COVID-19 compared to only 9% before the pandemic (Agrawal, et al., 2021).
• Drug clinical trials that utilized decentralized or virtual components increased by 93% in 2021 (Global Data, 2021).
• Between 2020 and 2021, mobile applications and devices were being integrated into clinical trial designs as evidenced by the 130% increase in the mention of text messages in clinical trial protocols (Parkins, 2022).
• 77% of United States-based investigators believe that there will be an increase in the implementation of remote patient monitoring procedures after the pandemic.

Why is clinical trial management software important?

As with the best scientific data management systems, clinical trial management software solutions provide a solid ground for scientific endeavors. Serving as a specialized project management tool, a CTMS provides research sites, teams, and organizations with a specialized clinical research software that delivers the following benefits:

• Accessible, accurate, and up-to-date record of data relevant to the organization and the study being conducted.
• Robust collaboration platform, which enables the members of the team to work together smoothly even from remote locations.
• Powerful automation tools to boost efficiency, especially when it comes to keeping track of tasks, collecting and updating patient information, progress of study, generating reports, etc.
• Upholds the integrity of the study by ensuring transparency and compliance with clinical research ethics and execution procedures.

Criteria for Choosing the Top CTMS

Clinical trial sites and research centers are not unfamiliar with the painstaking process involved in trial activities. From keeping track of patient enrollment, finances, to ensuring compliance, etc., each crucial stage takes a lot of time and manpower that affects the speed, efficiency, and even the accuracy of clinical trials. A clinical trial content management system provides a single platform that centralizes the critical aspects of the clinical trials and research, which makes it a staple tool in today’s clinical trial operations.

Modern clinical trial information management system may offer similar features and functionalities, but there are important factors to consider when it comes to choosing a CTMS that can keep up with the ever-changing environment of clinical trials and research. Some of these criteria are the following:

CTMS Industry Challenges

CTMS is not a new technology—legacy clinical trials software are now more or less two decades old and are still being used by several research sites and organizations. In fact, 17% of organizations do not have plans to modernize their clinical trial systems and processes, including their CTMS. This, however, presents a significant issue as legacy CTMS’ technology is no longer updated to keep up with the demands of today’s clinical trials and research.

With the majority—if not all—of legacy clinical site start up tools deployed on-premise, their capability to support decentralized clinical trial procedures is not sufficient. And while replacing legacy CTMS with cloud-based solutions seems to be the logical option, this also means implementing a major workflow overhaul, which requires retraining, identifying new roles, creating a new framework of procedures, and more. Furthermore, there is the issue with interoperability of different systems. According to a study that looks into the challenges of  clinical operations, the biggest challenge is integrating clinical applications, which is one of  legacy CTMS’ limitations. So, where would the best clinical trial data management system lead you? Perhaps, in the direction of resolving these challenges. 

A CTMS plays a critical role in enhancing collaboration among research teams, providing a unified platform for real-time communication and data sharing. Here’s how CTMS fosters collaboration in clinical trials:

• Centralized access to data: CTMS allows all team members to access up-to-date trial information, ensuring everyone is aligned and reducing data silos across departments.
• Real-time communication tools: Many CTMS platforms offer built-in messaging and notification systems, facilitating quick communication among team members about trial updates or protocol changes.
• Task assignment and tracking: CTMS enables project managers to assign tasks, set deadlines, and monitor progress, ensuring team accountability and transparency in task completion.
• Version control for documents: CTMS maintains version control of important documents, ensuring that team members always work with the latest protocols and research materials, reducing errors and miscommunication.
• Integration with other collaboration tools: Modern CTMS solutions integrate with popular collaboration tools, allowing seamless workflows and efficient information sharing between cross-functional teams.

By enhancing collaboration, CTMS improves the overall efficiency of clinical trials, enabling faster and more accurate decision-making across research teams.

Addressing Operational Efficiency Challenges in Clinical Trials

Despite the advantages offered by CTMS, operational challenges persist for many research organizations due to fragmented systems and outdated workflows. Addressing these inefficiencies is vital for enhancing productivity and ensuring successful trial outcomes.

One effective strategy involves integrating productivity-focused tools alongside a CTMS. For instance, the incorporation of employee productivity monitoring software can offer valuable insights into team performance, task timelines, and resource allocation. Such software enables research teams to identify bottlenecks and streamline operations by ensuring that each member is operating at their optimal capacity. Additionally, it provides a layer of transparency that supports better collaboration and accountability within distributed or hybrid teams.

Furthermore, organizations should consider investing in training that aligns their workforce with modern technological tools. Proper onboarding and continuous learning initiatives can reduce resistance to adopting new systems, paving the way for more synchronized and efficient processes.

Ultimately, enhancing operational efficiency in clinical trials is not just about adopting the right CTMS, but also about creating a cohesive technology ecosystem that addresses productivity challenges, enables real-time data sharing, and optimizes workflow management.

CTMS Industry Challenges

CTMS is not a new technology—legacy clinical trials software are now more or less two decades old and are still being used by several research sites and organizations. In fact, 17% of organizations do not have plans to modernize their clinical trial systems and processes, including their CTMS. This, however, presents a significant issue as legacy CTMS’ technology is no longer updated to keep up with the demands of today’s clinical trials and research.

With the majority—if not all—of legacy clinical site start up tools deployed on-premise, their capability to support decentralized clinical trial procedures is not sufficient. And while replacing legacy CTMS with cloud-based solutions seems to be the logical option, this also means implementing a major workflow overhaul, which requires retraining, identifying new roles, creating a new framework of procedures, and more. Furthermore, there is the issue with interoperability of different systems. According to a study that looks into the challenges of  clinical operations, the biggest challenge is integrating clinical applications, which is one of  legacy CTMS’ limitations. So, where would the best clinical trial data management system lead you? Perhaps, in the direction of resolving these challenges.

When implementing asset tracking in clinical trials, several key factors must be considered to ensure seamless integration and maximum benefit. One crucial aspect is the choice of asset tracking software that can efficiently monitor and manage the movement of equipment, supplies, and other assets across different locations. Additionally, the selected asset tracking system should be able to integrate with existing clinical trial management software (CTMS) to prevent data silos and enhance overall operational efficiency. By carefully evaluating these factors, research sites and organizations can optimize their asset tracking processes, reduce costs, and improve the overall success of their clinical trials.

List of Best Clinical Trial Management Software for 2025

1. encapsia: The Holistic and Future-proof EDC

First on our list of clinical trial software companies is encapsia. This agile software solution is designed to support decentralized clinical trials by allowing sites and organizations to create their own hybrid protocols based on study, organizational, and regulatory requirements. Another functionality that makes encapsia a powerful clinical trial management platform is its ability to capture clinical and metadata online and offline regardless of the type of data collection process.

All data is also synced to the system in real-time, which not only eliminates delays in reviewing patient information and home visit updates, it also makes relevant data readily available to other members regardless of their location. As for integration capabilities, encapsia’s REST API allows you to connect encapsia to other applications. And despite being easy to use, encapsia provides the service of consultants dedicated to helping clients tailor the platform to their study’s or organization’s precise needs.

Key Features

• eSource
• Electronic Data Capture (EDC)
• Home visit
• Live and interactive data
• Data management and monitoring
• Insights
• Medical coding
• Third-party data upload, review, and reconciliation
• API integration

Price

• Encapsia’s pricing is offered by quote and only available upon consultation.

2. MainEDC™: The AI-powered eClinical Platform

MainEDC™ is a clinical trial platform and medical research software that offers a comprehensive set of fully integrated tools, including EDC, Interactive Web Response System (IWRS), drug and supply management, and electronic Patient Reported Outcome (ePro). Powered by artificial intelligence, MainEDC™ simplifies the trials and studies conducted by clinical research organizations (CROs), Big Pharma, and biotech regardless of complexity. The platform is also equipped with blockchain technology, which ensures full and accurate audit trail of your data stored in qualified data centers.

Key Features

• Audit and inspections QA support
• Drag-and-drop study designer
• Built-in eCRF design approval tool
• Central and local laboratory data handling
• AI-powered medical coding
• Risk based monitoring tool
• Mobile or web-based patient access via MainEDC™ ePRO
• Rebranding/white labeling for mobile applications and mobile and desktop website
• Seamless integration with wearables (smart watches, fitness tracker, etc.)
• Advanced API
• Built-in reports
• Real-time interactive dashboards
• Trial and visit structure
• Hybrid study support
• Source data tracking for remote monitoring

Price

• The cost of MainEDC™’s plans vary depending on the number of users and other client-specific considerations. Pricing is only available upon request.
• Clients who want to secure private cloud, backup, and help desk support will have to pay at least $399/month.

3. EDGE: The Program Designed for Fast and Accurate Data Sharing

EDGE  was created in the Clinical Informatics Research Unit of the University of Southampton. Like most CTMS systems, the purpose of this software is to provide researchers with a unique and robust platform where they can efficiently keep track of their studies from start to finish, as well as get real-time access to research data.

As a collaboration platform, EDGE is designed to eliminate task overlaps and efforts, as well as ensure the integrity and protection of patient data. As of today, EDGE is utilized by 80% of the National Health Service in England, which covers the management of than 7 million patients and research participants.

Key Features

• Patient management and recruitment
• Real-time workflow process capture
• Customizable fields
•  Shared calendars
• In-depth reporting capabilities
• Patient monitoring
• Appointment and event tracking
• Finance recording, tracking, and reports
• Document storage and management
• Electronic responsibility delegation log

Price

• EDGE’s pricing plans are only available upon request.

4. Dot Compliance: The Pre-configured QMS for Life Science Industry

Dot Compliance is a quality management system designed to ensure the documentation and compliance of pharma and biotech, CROs, and medical device manufacturers. This platform offers three types of clinical trial management solutions that combine QMS with clinical trial management. The first is QMS Xpress, a pre-configured and deployment-ready solution ideal for organizations that are in the process of digitizing their compliance process.

Next is Compliance Xpand, which provides growing organizations with additional compliance tools they need as they scale up. Lastly, Enterprise Xact offers more flexibility for business enterprises to configure their own compliance processes.

Key Features

• Document management
• Change management
• Quality event management
• Audit management
• Training management
• CAPA management
• Deviations/Non-conformances
• Complaint management
• Risk management
• Supplier quality management
• Facility equipment management
• Electronic batch records
• Product lifecycle management
• Regulatory Information Management
• Design control
• IT compliance

Price

• Dot Compliance’s products’ pricing plans are only available upon request.

5. PRELUDE: The CTMS That Pre-builds Your Study

Prelude is a flexible EDC platform built with integrated clinical trial management features for both human and animal health studies. Developed by global life science software company Prelude Dynamics, Prelude is designed to simplify and accelerate clinical research while ensuring regulatory compliance. 

Prelude is offered in three types of solutions. First is Prelude EDC, a web-based application that enables you to create customized electronic case report forms (eCRFs) based on your study protocol, replacing traditional paper-based data collection methods. Next is Prelude ePRO, a mobile app that allows subjects to directly input clinical data through easy-to-use surveys, ensuring seamless syncing to the EDC system without the need for frequent site visits. And then there is Prelude Offline, which allows researchers to collect data in areas with limited or no internet access and automatically sync it once a connection is available—ideal for livestock, farm animal, and wildlife studies conducted in remote locations.

Key Features

• DIY EDC builder
• Form libraries
• Cross-form operations
• Create site forms
• Quick database lock
• On-demand reporting
• Auto data cleaning
• Archive in minutes
• Audit trail enabled
• Media upload
• Schedule survey forms
• Startup tracking
• Automated reminders
• Site initiation
• Site scoring system
• Site recruitment
• Aggregated study metrics

Price

• Prelude’s pricing plans are offered by quote and only available upon consultation.

6. Florence eBinders: The Software That Fully Digitizes Your Study Binder Workflows

Florence eBinders is a leading clinical trial workflow solution that serves as an accessible and secure platform for investigator files, logs, and participant binders. lIKE SOME OF THE This allows you to structure your own workflows according to your study and site requirements. It also comes with built-in compliance features that automate audit trails, user permissions, version control, etc.

This software solution is ideal for sponsors, CROs, and research sites that simultaneously conduct multiple studies in multiple locations as Florence eBinders offers remote monitoring options through its global dashboard, virtual workflows and task management, and more.

Key Features

• Online document management
• Full compliant eSignatures
• Remote access for sites, monitors, and auditors
• Permission-based access control
• Flexible and custom binder structures
• Project management
• Automated filing of centralized documents into eBinders
• CTMS integration
• EMR integration
• Outlook email integration
• Secure and compliant audit trails
• Dashboard for key metrics monitoring
• Unlimited document storage
• Custom SOP development

Price

• Florence eBinders’ pricing plan is available upon request.

7. Castor EDC: A DCT Platform with Native ePRO Feature

A modern and user-friendly clinical trial solution, Castor EDC caters to the needs of clinical trials and studies conducted by different industries. Among these industries are pharma and biotech, contract research organizations, medical device and diagnostics, and even academic research.

Like with automated contract management software, Castor EDC offers a compliant platform designed to capture, collect, and integrate clinical data from different sources and vendors. It also comes with ePRO and eConsent tools to make it more convenient for research participants. And beyond its powerful EDC system, this software solution also provides DCT modules for organizations that are still navigating hybrid clinical trials, as well as for those that have already implemented decentralized research.

Key Features

• Advanced eCRFs builder
• Flexible user management
• Database lock
• Up to 2GB large file uploads
• Audit trail
• Disaster recovery report
• Field-level encryption
• Two-factor authentication
• Automated pseudonym generation
• 15-year data retention
• ePRO surveys
• Smart segmentation
• Auto-lock completed surveys
• Real-time and automatic data save
• Granular audit logging
• Dynamic custom dashboard

Price

• Castor EDC offers personalized pricing based on type of organization, type of solution, and number of patients you plan to enroll.

8. RealTime CTMS: The CTMS That Automatically Manages CRC Activities

RealTime CTMS offers a complete clinical trial management system to help you manage research sites and networks, sponsor data, and CROs. It comes with robust scheduling tools that automate study targets and alerts and notifications on upcoming and tasks that are past due. RealTime CTMS also simplifies patient tracking with its user-friendly data entry, patient enrollment, and patient data access. Furthermore, this software solution provides advanced reporting capabilities that cover both study metrics and staff productivity.

In terms of integration, RealTime CTMS integrates with this-party platforms including Devana Solutions, Mailchimp, Twilio, Facebook ads, Outlook, and SubjectWell.

Key Features

• Website and Facebook ads integration
• Mobile app referral options
• Patient referral metrics
• Financial tracking
• Configurable progressive recruitment statuses
• Individual, departmental, and company calendars
• Automated reminders
• Email blast and mass texting campaigns
• Task management
• Patient visit tracking
• Advanced reporting
• Contracts and budgets
• Accounting
• Financial reports
• Multiple integrations

Price

• RealTime CTMS’ pricing is offered by quote.

9. Clinical Conductor: The Purpose-built CTMS for Enterprise Institutions

A comprehensive and scalable clinical management trial management system, Clinical Conductor aims to help you streamline enrollment and communication, standardize clinical research compliance, enhance transparency and visibility, and maximize financial investments. Aside from its main CTMS platform, Clinical Conductor also offers OnCore, which is a purpose-built CTMS for enterprise institutions, such as academic medical and cancer research centers.

When it comes to integration, Clinical Conductor connects with other EDC, EMR, and other third-party systems via API.

Key Features

• Electronic consent
• eSource
• eRegulatory Management System
• Research ROI reporting
• EDC
• Automated participant payments
• Dedicated platform for sponsors, sites, and participants
• Document sharing

Price

• Clinical Conductor’s pricing is available upon request.

10. Studypages: Integrated Platform for Clinical Research

Studypages offers a comprehensive, integrated platform designed to revolutionize clinical research by connecting participant journeys and site operations. This unified approach accelerates research timelines through a suite of powerful tools that enhance engagement, communication, and collaboration. As a dedicated technology partner, Studypages collaborates with leading research organizations to develop specialized, modular technology solutions tailored to the unique demands of clinical trials.

Their platform empowers sites to efficiently manage participant recruitment and retention, simplify complex workflows, and improve data quality. By centralizing key processes and fostering seamless information flow, Studypages reduces administrative burden and allows researchers to focus on what matters most: advancing scientific discovery and improving patient care. Ultimately, Studypages aims to optimize clinical research by providing a user-friendly and adaptable platform that addresses the diverse needs of the industry.

Key Features

• Study Listing & Gallery

• Participant Tracking & Management

• Secure Chat & Calls

• Teamwork & Organization

• Automation & Organization

• Web & Mobile Access

• Pre-screening

• E-consent

• Survey Completion

• Recruitment Page

• Gallery

• Invite Campaign

• Registry

• Calling & Voicemail

• Notes, Statuses & Tags

• Video Visits

• Research On-The-Go

• Team Management

• Configurable Workspace

• Integrations & Automation

• Visit Scheduling

Pricing

• Pricing is available upon request from the vendor.

11. ClinCapture: The CTMS Solution with Proprietary Clinical Cloud for Researchers

ClinCapture offers a selection of proprietary EDC and VDC products for sponsors, CROs, clinical trial study consultants, and others. Its Virtual Data Capture solution contains four modules designed to support decentralized clinical trials. These modules include ePRO, eConsent, eCOA, and eSource.

Captivate Electronic Data Capture, on the other hand, provides a more advanced and scalable platform for research sites and organizations that conduct studies with varying levels of budget and complexity. Captivate EDC is also modular and can be tailored according to the needs and requirements of the study, site, or organization. Furthermore, Captivate EDC seamlessly integrates with CTMS, learning management systems, and other external integrations via web service APIs.

Key Features

• ePRO
• eConsent
• eCOA
• eSource
• Randomization and trial supply management
• Medical coding
• Risk-based monitoring
• Form versioning
• Standard and advanced reporting and analytics
• Advanced integrations

Price

• Pricing plans for VDC, Captivate EDC, and individual modules are provided upon request.

12. Zelta: The Unified CDMS with Modular EDC

Zelta by Merative is a comprehensive cloud-based solution for clinical trial management, tailored for the life sciences industry including biotechnology and pharmaceutical organizations. It streamlines clinical trials with advanced data management capabilities, improves operational efficiency, and enhances data integrity. The platform's flexibility supports a range of trial sizes and complexity, enabling users to meet diverse global regulatory requirements. Additionally, Zelta facilitates better decision-making through real-time data analytics and AI-driven insights.

Key Features

• Electronic Data Capture (EDC)
• Real-Time Data Monitoring
• Adaptive trial design with AI assistance
• Integrated patient engagement tools (eCOA/ePRO)
• Compliance with global regulatory standards

Price

• Zelta offers a flexible pricing model, including subscription and pay-per-use options. Specific pricing details are available upon request.

13. Dacima Clinical Suite: The Software That Combines CTMS, CDMS, and EDC

Dacima Clinical Suite is a sophisticated clinical trial application that combines CDMS, CTMS, and EDC in one platform. Aside from being an all-in-one clinical trial solution, Dacima Clinical Suite also offers flexibility as it allows users to design their own databases. All parameters are also user-configurable, which is also easy to do with its user-friendly graphical user interface that does not require any advanced programming knowledge to navigate.

Dacima Clinical Suite’s technology is built on the Microsoft.net framework and divided into three modules—administrator, designer, and data entry— each equipped with role-based capabilities and permissions. As for integrations, Dacima Clinical Suite enables you to import data from any software system, as well as with Salesforce and Rybbon Digital Gifting.

Key Features

• Form designer
• Dynamic visit structure
• Subject scheduling
• Multistage enrollment
• Image-based data entry
• Randomization
• Adaptive randomization/minimization
• Drug supply management module
• Real-time validation checks
• Offline data entry
• Dynamic form activation
• Interactive dashboards and custom reporting
• Monitoring module
• ePRO
• Web survey module
• Patient diary
• Data importation module
• Advanced data extraction
• Specialized coding
• Integrations

Price

Dacima Clinical Suite tailors its pricing plan according to the needs and requirements of clients. Clients can choose from the following clinical trial data management software offerings:

• Academic Web-based and ideal for clinical trial startups and academic research studies
• Pay per study Each module is priced individually, which makes this ideal for experimental studies.
• Enterprise licensing On-site software installation and includes user training. This is ideal for CROs and requires an annual support fee.

14. nQuery: The Trial Design Platform That Predicts Key Trial Milestones

nQuery is a trial design platform for academic and commercial organizations that use Classical or Bayesian statistics, adaptive trial, and trial prediction approach to clinical studies. The platform was created to optimize and innovate clinical trial designs and speed up clinical trial procedures with the help of its robust features and utilities, such as automated sample size calculation.

nQuery’s reliability makes it a popular choice among various academic, government, and private organizations. In 2021 alone, 88% of organizations with FDA-approved clinical trials are nQuery clients. Some of them are Biogen, Sanofi, Astrazeneca, Pfizer, Johnson & Johnson, World Health Organization, the University of Miami, and more.

Key Features

• Thousands of Fixed Term Trial Scenarios
• Endpoints (means, survival, agreement, count, regression, etc.)
• Designs (cross-over, stepped-wedge, cluster randomized, etc.)
• Statement generator
• IQ/OQ Procedures
• Assurance
• Credible intervals
• Mixed Bayesian/Likelihood intervals
• Continual reassessment method
• Posterior error rates
• Blinded/Unblinded Sample Size Re-estimation
• Group Sequential Design
• Recruitment prediction
• Events prediction
• Self-service knowledge base
• 24/7 customer support

Price

nQuery has four levels of pricing plans with each price varying between academic institutions and commercial organizations.

• Academic Base $595 per user/yearPlus $895 per user//yearPro $1,645 per user/yearExpert $3,495 per user/year
• Base $595 per user/year
• Plus $895 per user//year
• Pro $1,645 per user/year
• Expert $3,495 per user/year
• Commercial Base $695 per user/yearPlus $1,045 per user/yearPro $3,295 per user/yearExpert $6,995 per user/year
• Base $695 per user/year
• Plus $1,045 per user/year
• Pro $3,295 per user/year
• Expert $6,995 per user/year

15. ARCS: A Research Platform That Empowers Participants

A product of Marketing Systems Group, ARCS is designed as a panel management platform that optimizes engagement of participants. This platform is equipped with tools to help you grow your panel through its automated recruitment capabilities. Identifying the best participants for a study using ARCS’ custom screeners. This platform also eliminates the time-consuming task of scheduling research participants as they are in-charge of creating their own schedules based on their availability.

Keeping participants engaged is another area where ARCS shine as the platform implements an incentive system via products, gift cards or points ,which leaves a positive impact on participation and engagement rates. As for integrations, ARCS integrates seamlessly with social media platforms.

Key Features

• Panel recruitment
• Survey creation
• Real-time survey results
• Reporting
• Scheduling
• Workflow automation
• Multi-channel engagement
• Project management
• Extendable data platform
• Rewards via ARCS Pay

Price

• ARCS’ pricing information is available upon request.

16. Clario: The CTMS That Offers Cost-effective eTMF Integration

Clario offers an end-to-end management system for clinical trials in different therapeutic areas, such as cardiac safety, infectious diseases, hepatology, neuroscience, respiratory, and oncology, among others.

Its dedicated CTMS software provides organizations with a full-featured platform that is also integrated with Electronic Trial Master File (eTMF) for more efficient, accurate, and secure consolidation of clinical data. Clario’s CTMS also utilizes the Microsoft Office work environment, which enables the platform to utilize Microsoft Office tools.

Key Features

• eTMF integration
• Monitoring Visit Report module
• Microsoft Office-Smart
• Automated workflows
• Contact management
• Payment module
• Inventory control module
• Reporting and tracking with customer-defined milestones
• Role-based access and views
• Extensive standard and custom reports

Price

• Clario’s CTMS’ pricing is pay as you go and will be determined upon consultation.

17. CTMS Master: The CTMS with Fully Integrated Monitoring Tools

CTMS Master is designed for optimum efficiency while keeping compliance risk at a bare minimum. One of its core capabilities is its protocol deviation management, which keeps you alert on manual and system-generated deviations. This feature also comes with automated resolution capabilities and documentation of corrective actions and improvements in the process to prevent potential issues. CTMS Master is also equipped with robust finance management tools that help streamline the budgeting, payment, and approval process.

As for integration, CTMS Master works seamlessly with other Anju Software systems, such as TrialMaster and third-party eTMF, EDC, and IVRS solutions.

Key Features

• Custom templates
• Integrated Site Visit Report (SVR) Tools
• Informed consent tracking
• Protocol deviation management
• Study finance and budget management
• Multiple integrations

Price

• CTMS Master’s pricing details are available upon request.

18. OpenClinica: The EDC Platform with Customizable eCRFs

OpenClinica brings smart clinical data management to clinical trials and studies. Its main offering is a powerful cloud-based EDC that can accommodate a broad spectrum of clinical research and trials, all types of therapeutic areas, as well as COVID-19 research studies

Aside from  EDC, OpenClinical also offers other solutions, such as ePRO, randomization, and reporting that can be added to the EDC system to further enhance its capabilities. OpenClinica also has its own EHR eSource integration, which enables its EDC to collect medical data from other platforms.

Key Features

• Intuitive eCRFs
• Drag-and-drop form builder
• Fully integrated ePRO
• Real-time enrollment tracking
• Adverse events alert
• Interactive data visualizations
• Custom dashboards
• Protocol compliance
• Custom and pre-created reports
• Patient randomization
• EHR integration

Price

• OpenClinica software solutions’ pricing information are available upon request.

19. Research Manager: The CTMS for Digitizing Study Requests and Portfolio Monitoring

Research Manager’s CTMS is designed to cater to all types of organizations within the life science sector. This platform enables organizations to fully digitize the process of study request and monitoring portfolios relevant to the study. Among the tools it offers are custom workflows, financial management, electronic document and records management, and more.

This CTMS can also integrate with Research Manager’s EDC and ethical review management system. Third-party applications can also get linked to the CTMS platform via API, SSO, SURFcontext, and EPD.

Key Features

• Workflow management
• Communication management
• Role-based access control
• Contract and document management
• ERMS tool
• Study dashboards
• Financial management
• Amendments and reports
• Audit trail
• Anonymized patient details
• Smart safety reporting
• Native and API integrations
• Training

Price

• Research Manager CTMS subscription plan is offered by quote and starts at €89/month.

20. Medrio: The eClinical Software for Traditional and Decentralized Clinical Trials

Medrio offers a suite of flexible clinical trial technology for all types of industries that conduct traditional, virtual, or hybrid clinical trials. Among the solutions Medrio offers are EDC, ePRO, electronic consent, direct data capture (DDC), RTSM, and decentralized clinical trial capabilities.

Aside from software solutions, Medrio also offers services that connect clients with experts who will help them successfully carry out various clinical trial processes. These professional services include data management plan development, biostatistics, study closeout and database delivery, eCRF design and build, and more.

Key Features

• Decentralized clinical trials
• Direct data capture
• Electronic data capture
• Electronic consent
• Randomization and trial supply management
• Electronic patient-reported outcomes
• Professional services

Price:

• Medrio’s pricing information is available upon request and consultation.

21. Ripple: The CTMS with Robust Team Management Capabilities

Ripple is a clinical trial software designed to address the biggest challenges of researchers when it comes to patient recruitment, engagement, and retention. With Ripple, all communication and information-sharing among research team members are centralized. Email alerts are also sent on a regular basis to keep each team member updated on the status of their participants.

Ripple also provides research teams with task and workflow automation tools, so the research team members can have more time to focus on their participants. Furthermore, patient journeys can be mapped out and tailored based on patient requirements, which helps enhance their experience.

Key Features

• Custom screening forms
• Participant profile card
• Participant scheduling
• Emailing and text messaging
• Task management
• Study dashboard
• Custom workflows
• Registry
• Security and compliance

Price

• Pricing plans for Ripple products are available upon request.

Why is clinical trial management software important?

As with the best scientific data management systems, clinical trial management software solutions provide a solid ground for scientific endeavors. Serving as a specialized project management tool, a CTMS provides research sites, teams, and organizations with a specialized clinical research software that delivers the following benefits:

• Accessible, accurate, and up-to-date record of data relevant to the organization and the study being conducted.
• Robust collaboration platform, which enables the members of the team to work together smoothly even from remote locations.
• Powerful automation tools to boost efficiency, especially when it comes to keeping track of tasks, collecting and updating patient information, progress of study, generating reports, etc.
• Upholds the integrity of the study by ensuring transparency and compliance with clinical research ethics and execution procedures.

Criteria for Choosing the Top CTMS

Clinical trial sites and research centers are not unfamiliar with the painstaking process involved in trial activities. From keeping track of patient enrollment, finances, to ensuring compliance, etc., each crucial stage takes a lot of time and manpower that affects the speed, efficiency, and even the accuracy of clinical trials. A clinical trial content management system provides a single platform that centralizes the critical aspects of the clinical trials and research, which makes it a staple tool in today’s clinical trial operations.

Modern clinical trial information management system may offer similar features and functionalities, but there are important factors to consider when it comes to choosing a CTMS that can keep up with the ever-changing environment of clinical trials and research. Some of these criteria are the following:

• Customizability. A clinical trial management software must offer high levels of customization, particularly in reports and analytics and process automation in order to accommodate the different standard operating procedures, internal policies, and best practices followed by sites, research centers, or organizations.
• Usability. Although designed to handle the intricate aspects of clinical trial management, a CTMS does not need to be as complex. Having a user-friendly interface is important, especially for sites and organizations that are adopting a CTMS software for the first time.
• Accessibility. The ability to access a CTMS platform from any research site is another important criteria to consider. Web-based CTMS solutions offer this capability, which helps enhance efficient collaboration among members of the team.
• Interoperability with other systems. Another factor to consider when choosing a CTMS is its capability to integrate with other tools that your site or organization is already using. This is necessary to ensure smooth automation of processes and secure data migration between platforms.
• Value for money. The cost of CTMS solutions vary depending on the type of deployment, service packages, add-on fees, etc. While there are CTMS for different budget ranges, it is important to make sure that the features address the needs of the site or organization and the clinical trials they conduct.

What is in store for the future of clinical trials?

There is no denying that technology plays a crucial role in modernizing clinical trial processes. And in this case, the best clinical trial management softwares serve as a fundamental element in helping research sites and organizations catch up with the modern demands of clinical studies. With clinical research becoming more and more global, cloud-based CTMS’ capability to support extensive and complicated clinical trial operations through the implementation of job automations, which have become more crucial to the speed, efficiency, accuracy, security, and ROI of modern clinical trials.

One thing that this list of leading CTMS solutions showcases is not every CTMS is a one size fits all solution. Each one, however, brings innovation in design, feature, or integration that addresses specific problems faced by research sites and organizations that are still navigating the continuously changing environment of clinical trials and research.

The need for accurate and timely digital systems spills over to governments and businesses alike. This nowhere more apparent in the need for crucial emergency management software tools to deal with all sorts of public and business emergency situations.

Key Insights

• Increased Adoption of Decentralized Trials: The COVID-19 pandemic has accelerated the adoption of decentralized clinical trial components, leading to a significant increase in virtual and remote patient monitoring.
• Technological Integration: Modern CTMS solutions integrate various technologies such as mobile applications, AI, and blockchain to enhance data accuracy, security, and efficiency in clinical trials.
• Regulatory Compliance and Reporting: CTMS platforms ensure compliance with regulatory requirements and streamline the documentation and reporting processes, which are critical for the integrity of clinical trials.
• Customization and Flexibility: High levels of customization in CTMS solutions allow research sites to tailor the software to their specific needs, improving the efficiency and effectiveness of clinical trials.
• Enhanced Collaboration: Features like real-time data synchronization, remote access, and automated workflows facilitate better collaboration among research team members, even across different locations.
• Cost Efficiency: The adoption of CTMS helps reduce operational costs by automating many manual processes, ensuring timely updates, and reducing errors in clinical trial management.
• Data Accessibility: Cloud-based CTMS solutions provide secure, real-time access to data from any location, ensuring that all team members have up-to-date information to make informed decisions.
• Patient Engagement and Retention: Features such as ePRO, eConsent, and automated communication tools help maintain high levels of patient engagement and retention throughout the trial process.
• Integration with Existing Systems: Modern CTMS platforms offer robust integration capabilities with other tools and systems like EDC, EMR, and third-party applications, ensuring seamless data flow and process automation.
• Focus on User Experience: User-friendly interfaces and intuitive design in CTMS solutions ensure that even those with limited technical skills can efficiently navigate and utilize the software.

FAQ

1. What is a Clinical Trial Management System (CTMS)? A Clinical Trial Management System (CTMS) is specialized software designed to manage the various aspects of clinical trials and research studies. It helps streamline processes, maintain compliance, and ensure efficient collaboration among research teams.
2. Why is CTMS important in clinical trials? CTMS is important because it centralizes and automates critical components of clinical trials, such as patient enrollment, data collection, compliance tracking, and reporting. This enhances the efficiency, accuracy, and speed of clinical research.
3. How has the COVID-19 pandemic impacted the use of CTMS? The COVID-19 pandemic has accelerated the adoption of decentralized clinical trial components and remote monitoring. This shift has increased the reliance on CTMS to manage virtual interactions, remote data collection, and ensure continuity of trials during lockdowns.
4. What features should I look for in a CTMS? Key features to look for include data management and monitoring, patient recruitment and tracking, real-time data synchronization, regulatory compliance, customizable reports, integration capabilities with other systems, and user-friendly interfaces.
5. Can CTMS solutions integrate with other clinical trial tools? Yes, modern CTMS solutions offer robust integration capabilities with other tools such as Electronic Data Capture (EDC) systems, Electronic Medical Records (EMR), and various third-party applications. This ensures seamless data flow and process automation.
6. How do CTMS platforms ensure regulatory compliance? CTMS platforms ensure regulatory compliance by automating documentation processes, maintaining secure and accurate audit trails, providing role-based access controls, and generating comprehensive reports that adhere to regulatory standards.
7. What are the benefits of using cloud-based CTMS solutions? Cloud-based CTMS solutions provide real-time access to data from any location, facilitate remote collaboration, reduce infrastructure costs, and ensure data security and disaster recovery through cloud storage.
8. How do CTMS platforms enhance patient engagement and retention? CTMS platforms enhance patient engagement and retention by providing tools such as electronic Patient Reported Outcomes (ePRO), electronic consent (eConsent), automated reminders, and communication features that keep patients informed and involved throughout the trial.
9. What challenges do organizations face when adopting a new CTMS? Challenges include the need for training and retraining staff, integrating the new CTMS with existing systems, ensuring data migration accuracy, and developing new workflows and procedures to align with the capabilities of the new system.
10. How do CTMS solutions handle data security? CTMS solutions handle data security by implementing encryption, secure access controls, regular security audits, compliance with data protection regulations, and providing secure data storage and backup solutions.

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