by
Imed Bouchrika, Phd
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 software 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:
Source: McKinsey & Company, 2020
As with the best scientific data management systems, clinical trial management software solutions provide a solid ground for scientific endeavors. A CTMS provides research sites, teams, and organizations with a specialized comprehensive project management platform that delivers the following benefits:
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 management software 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 CTMS 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:
Source: Veeva
CTMS is not a new technology—legacy CTMS 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 CTMS 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 management software lead you? Perhaps, in the direction of resolving these challenges.
First on our list of CTMS 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.
MainEDC™ is a clinical trial platform 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.
EDGE was created in the Clinical Informatics Research Unit of the University of Southampton. 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.
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 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.
VISION is a versatile EDC tool integrated with the core features of clinical trial management and clinical data management software. A product of global eClinical solutions and services providers, Prelude Dynamics, VISION is designed for clinical trials in both human and animal health sciences.
VISION is offered in three types of solutions. First is VISION Study Builder, which enables you to create your own EDC using the platform’s user-friendly drag-and-drop interface. Next is VISION ePRO to make it easier to collect clinical data from patients and sync their information to the EDC system. And then there is the VISION Study Startup, which offers the necessary tools to help you manage your clinical studies remotely.
Florence eBinders is a leading clinical trial workflow solution that serves as an accessible and secure platform for investigator files, logs, and participant binders. 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.
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.
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.
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.
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.
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.
IBM Clinical Development is a unified CDMS with powerful EDC core features to help CROs and pharmaceutical and medical device companies with their clinical trials from start to finish. Powered by IBM’s infrastructure, IBM Clinical Development offers a scalable platform that can support thousands of clinical trials. This solution is also highly adaptable and designed with an intuitive interface to make it easier for the users to navigate even complex processes.
As for its integration capabilities, IBM Clinical Development provides its users with tools to build and automate their own data connectors with minimal coding to integrate the platform with third-party systems.
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.
Dacima Clinical Suite tailors its pricing plan according to the needs and requirements of clients. Clients can choose from the following offerings:
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.
nQuery has four levels of pricing plans with each price varying between academic institutions and commercial organizations.
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.
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.
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.
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.
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.
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.
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.
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.
by Imed Bouchrika, Phd
by Imed Bouchrika, Phd
by Imed Bouchrika, Phd
