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CTMS in Clinical Trials: Top Solutions
Clinical trial management systems (CTMS) in clinical trials
Clinical trial management systems (CTMS) are software programs designed to support clinical trials by providing a centralized platform for managing and monitoring all aspects of the trial[1]. CTMS typically include modules for study planning, site selection and initiation, patient enrollment, data collection and management, regulatory compliance, and study reporting[2].
What is a CTMS used for in clinical trials?
CTMS support the management and monitoring of clinical trials through a digital platform that centralizes data and documentation to facilitate the conduct and tracking of clinical trial operations, from study planning through to data collection and study reporting[3].
Some specific ways that CTMS are used in clinical trials include:
- Study planning: CTMS can be used in the creation of study timelines, allocation of resources, and in establishing study milestones.
- Site selection and initiation: CTMS can help in the process of identifying and evaluating potential study sites, managing the site initiation process, and tracking site progress.
- Patient enrollment: A CTMS can help monitor patient recruitment and enrollment to ensure that enrollment targets are being met and that patient data and visit schedules are recorded accurately.
- Data collection and management: CTMS are used to collect, store, and manage study data, to ensure that data is captured accurately, stored securely, consistent across documents/sites, and easy to access. A related type of system specifically focused on data management is called a clinical data management system (CDMS).
- Regulatory compliance: CTMS can help investigators and sponsors verify and demonstrate that the study is conducted in compliance with regulatory requirements, further providing audit trails to support regulatory inspections.
- Study reporting: CTMS can be used to generate clear and insightful reports on study progress, site performance, patient enrollment, and data management.
Top 10 trusted CTMS (clinical trial management system) vendors
Below is our list of the top 10 trusted clinical trial management system vendors. Each vendor offers unique features that can help clinical trial managers with their clinical research.
Medidata Rave CTMS
Medidata Rave CTMS forms part of Medidata’s unified Clinical Cloud® platform and integrates seamlessly with Medidata’s Rave EDC and Rave eTMF, offering a comprehensive, unified suite of solutions that is fully customizable to the design of each unique trial and the needs of the sponsor. This integration means that document management is streamlined and efficient, reducing data entry errors and inconsistencies[4]. Rave clinical trial management system also integrates with risk-based monitoring solutions and offers an “Intelligent Risk Detection” dashboard, allowing sites and CRAs to closely monitor patient safety with real-time data[5]. Its “Visual Analytics” is a unique feature enabling data captured from EDC systems to be plotted and summarized in intuitive infographics for enhanced report creation.
May be ideal for: Sponsors looking for a single reliable provider of clinical project management, patient engagement, and data capture functions all integrated into one central workflow.
SimpleTrials
SimpleTrials CTMS provides a comprehensive suite of features for clinical trial management. It is an intuitive, user-friendly, and cost-effective solution that can streamline the clinical trial process for small- to mid-size clinical research organizations (CROs).
One of the unique features of SimpleTrials is its simplicity. The platform is easy to use, with a clean and user-friendly interface that makes it easy to navigate. Users can quickly and easily access study information, monitor site performance, track patient enrollment, and manage study data[6].
Another great feature of Simple Trials CTMS is its flexibility. The fully customizable CTMS can be tailored to meet the specific needs of any trial or research organization. It offers modules for study planning, site selection, patient enrollment, data management, and study reporting. These modules can be customized to match the requirements of the clinical trial, making SimpleTrials CTMS a versatile and adaptable platform[7].
May be ideal for: Sponsors that need an easy-to-use and customizable yet cost-effective clinical trial management system. Its user-friendly interface and customizable modules make it an ideal choice for organizations with limited IT resources, budget constraints, or less complex clinical trial needs.
RealTime CTMS
RealTime CTMS is designed to streamline and simplify the management of data in clinical trials. One of the standout features of RealTime CTMS is its customizable dashboard, which allows users to track key performance indicators (KPIs) and metrics in real-time. It also includes robust site management tools such as site initiation checklists, site activation reports, and site visit tracking. A unique feature of RealTime CTMS is its integration with RealTime-CTMS Calendar, a scheduling tool that allows sponsors to manage patient appointments, monitor patient compliance, and track patient progress in real-time [8].
May be ideal for: Sponsors looking for a comprehensive, cloud-based CTMS solution that can support the entire clinical trial process through insightful real-time oversight facilitated by the customizable dashboard.
Advarra OnCore CTMS
Advarra OnCore CTMS is a comprehensive CTMS software designed for research organizations, academic medical centers, and healthcare systems. The CTMS is built to streamline the management of clinical trials by providing a single, integrated platform for managing all aspects of study lifecycle, including study design, clinical trial site management, patient management, and study finances[9].
Advarra OnCore provides a central point of control for all clinical trial activities, allowing users to manage multiple studies and sites from a single platform, and offers a high degree of customizability and configurability so the platform can be tailored to meet the specific needs of the organization.
May be ideal for: Sponsors and larger organizations looking for a comprehensive, integrated platform to manage all aspects of the clinical trial lifecycle across multiple trials or in complex research environments.
Advarra Clinical Conductor CTMS for sites
Whereas their OnCore CTMS is meant for enterprise-level operations, Advarra’s Clinical Conductor CTMS is a comprehensive clinical trial software solution designed for sites, which provides a customizable and user-friendly interface adaptable to each study site's specific needs. One of the standout features of Advarra Clinical Conductor CTMS is its ability to integrate with other clinical research management systems, electronic data capture (EDC) systems, and patient engagement tools, offering streamlined workflows, advanced reporting capabilities, and allowing site staff to generate customized reports on study progress, site performance, patient enrollment, and other metrics[10]. The system provides real-time alerts and notifications to help site staff comply with regulatory requirements, ensuring that the study is conducted ethically and in line with all applicable regulations.
May be ideal for: Sponsors looking to equip their sites with an efficient and effective CTMS optimized for the site level.
BSI CTMS
BSI CTMS is designed to support sponsors in managing clinical trials efficiently and effectively by providing a complete end-to-end solution, covering all aspects of clinical trial management from study planning and site selection to data collection and analysis. BSI CTMS integrates readily with other systems such as EDC, which can help streamline data transfer and ensure that data is captured accurately and securely. Moreover, the system supports risk-based monitoring, helping sponsors identify risk areas and prioritize monitoring activities accordingly, which can help reduce overall monitoring costs and improve data quality[11].
May be ideal for: Sponsors looking for a comprehensive and flexible solution to manage their clinical trials which can be customized to meet the specific needs of each study and is readily scalable.
IQVIA CTMS
IQVIA CTMS is part of IQVIA's Digital Trial Management Suite and is designed to help sponsors make clinical trial operations more efficient, from trial planning to closeout. IQVIA CTMS offers a range of functionalities that make it a valuable asset for pharmaceutical and biotech companies of all sizes, such as real-time data and analytics which facilitates quick, data-driven decisions.[12] The platform is customizable and can be tailored to the specific needs of each study, allowing sponsors to configure workflows, dashboards, and reports according to their preferences.
May be ideal for: Trial sponsors and managers looking for a comprehensive, scalable, and customizable clinical trial management solution that offers powerful, real-time data and analytics.
Clario CTMS
Clario CTMS provides end-to-end trial management support for sponsors and clinical trial managers. It features an intuitive, user-friendly interface that allows users to efficiently manage all aspects of their trials, from study planning and design through to execution and monitoring. Clario's built-in analytics and reporting capabilities allow sponsors to gain insights into their trial data and make informed decisions based on the results. The system also offers real-time data monitoring, alerts, and notifications, supporting quick identification and resolution of any issues that arise during the trial[13].
May be ideal for: Sponsors looking for a robust and scalable clinical trial management system that can support multiple studies simultaneously, particularly complex multi-site trials.
Calyx CTMS
Calyx CTMS is a cloud-based CTMS that is flexible and intuitive, and has been optimized over the course of its use in over 60,000 clinical trials. It offers robust reporting and analytics capabilities, allowing sponsors to monitor trial progress and performance in real-time. The system's reporting tools provide insights into key metrics such as enrollment rates, protocol compliance, and adverse event rates, making it easy for sponsors to identify potential issues and take corrective action quickly[14].
May be ideal for: Sponsors looking for a tried and trusted, powerful and highly flexible CTMS that can be adapted to trials of any phase or level of complexity.
Veeva Vault CTMS
Veeva Vault CTMS is designed to help streamline clinical trial operations and improve collaboration between sponsors, investigators, and other stakeholders. The CTMS integrates seamlessly with other trusted Veeva products, such as Veeva Vault eTMF and Veeva Vault Clinical Data Management System, allowing for streamlined workflows and data exchange and helping to eliminate data silos, leading to improved visibility and more efficient clinical trial processes[15].
May be ideal for: Veeva CTMS is particularly well-suited for companies managing complex, multi-site trials and those looking to directly integrate the functions of the CTMS with other electronic trial/data management solutions.
What to look for in a CTMS
Pretty much all CTMS help streamline clinical trial operations management, improve stakeholder collaboration, and ensure compliance with regulatory requirements. With so many CTMS options available, knowing what to look for when choosing a system that fits your trial’s or organization’s needs can be challenging. Below are some key features to keep in mind when selecting a CTMS for clinical trials.
Easy-to-use interface
The user interface is one of the most important factors to consider when choosing a CTMS. A clear and user-friendly interface can reduce training time and ensure users can easily navigate the system. When evaluating CTMS options, look for systems with an intuitive interface and customizable dashboards and reports, which will facilitate easy clinical trial information management.
Comprehensive functionality
A CTMS should provide comprehensive functionality to support all aspects of clinical trial management. This includes aspects of study setup and management, patient enrollment tracking, visit scheduling, adverse event monitoring and reporting, data management, regulatory compliance, and more. Choosing a CTMS that offers a range of features that can be customized to meet your specific needs is important.
Integration capabilities
A CTMS should integrate seamlessly with other systems you plan to use for the clinical trial, such as electronic data capture (EDC) systems and electronic trial master files (eTMF). This integration helps to ensure that data is shared efficiently and accurately between systems, reducing the risk of errors and saving time by avoiding redundancy and manual data entry. It also greatly facilitates document and data access by different sites and stakeholders. When evaluating CTMS options, look for systems that offer robust integration capabilities, whether with the same provider’s own solutions or third-party software.
Compliance with regulatory requirements
Compliance with regulatory requirements is critical when conducting clinical trials. A CTMS should support compliance with regulations such as Good Clinical Practice (GCP) and 21 CFR Part 11, which govern electronic records and signatures[16],[17]. Look for a CTMS with built-in features that support compliance, like audit trials and electronic signatures.
Flexibility and scalability
A CTMS should be flexible enough to adapt to changing needs, and scalable to accommodate growing trial portfolios. When evaluating CTMS options, look for systems that offer a high degree of customizability, and the ability to add new users and functionality as needed. This way you will be able to use the same system for future trials regardless of how different they may be, avoiding spending extra time and resources on repeated training on different systems.
Conclusion
A CTMS is generally considered a must-have in the current landscape of increasingly complex and digitalized clinical trials. Selecting the right CTMS for your clinical trials is crucial to ensuring efficient and effective trial management. When evaluating CTMS options, choose a CTMS that matches the complexity of your trial and offers the functionalities you need while also being flexible, integrates readily with any other technologies you use or plan to use, and is reliable and trusted. A well-selected CTMS that is easy to use will be a great tool for streamlining clinical trial operations and improving stakeholder collaboration.