The World’s Top 10 Clinical Trial Management Software Solutions

Last Updated on December 19, 2020

Clinical Trial Management Software – Clinical Data Management (CDM) is a critical practice in clinical research that produces high quality, reliable and statistically valid data from clinical trials. Clinical data management ensures the collection, integration and availability of data of appropriate quality and value. It also supports the conduct, management and analysis of research across the full spectrum of clinical research as defined by the National Institutes of Health (NIH).

Clinical trials are complex projects, and managing its various aspects is too complicated for traditional project management software. Individual apps can set budgets, data collection, compliance, research schedule, and more. However, working with different platforms that are not interconnected is ineffective. It’s best to keep all this information in one place so you don’t miss anything.

Clinical trial management software covers all of these attributes of your research project and more. Centralized databases, robust analyzes and fully-featured patient management functionality are some of the features of today’s CTMS. In this article, we’ll take a look at the top 10 clinical trial management software on the market today, and how each can help you with your project.

Top 10 Clinical Trial Management Software Solutions

1. IBM Clinical Development

IBM Clinical Development ranked number one on our list of the top 10 clinical trial management software for its comprehensive CTMS functionalities. Offering a unified, cloud-based electronic data collection tool that provides a 360-degree view of critical trial data, this platform is designed to help you improve your research workflow. It also comes with patient engagement modules as well as randomization and trial supply management tools to help you execute your clinical studies as smoothly as possible. To further streamline your workflow, it also comes with data integration so you can automate data input and synchronization. Among its other notable functionalities real-time analytics, medical coding, and endpoint adjudication. IBM Clinical Development also has a quality control and compliance management module to help you make sure that your processes adhere to industry regulations.

2. Edge CTMS

Edge CTMS by Medidata is a robust cloud-based application created to streamline all aspects of research management from budgeting to evaluation. Ideal for businesses of all sizes, it leverages agile development methodology in order to help you maintain a steady pace in your clinical research even in the event of unforeseen circumstances. With it, you can easily evaluate the effectiveness of your processes as well as make modifications to your workflow with minimal disruption to your operations. The platform also integrates with Rave EDC so you can monitor the real-time status of your research progress. As for data management, Edge CTMS has an open architecture that lets it exchange data with other business systems as effortlessly as possible.

3. MasterControl CQMS

MasterControl CQMS is a clinical trials management software that is designed to help life science organizations manage their documents, project tasks, activities, quality events, audits and training, to name a few. It is capable of boosting efficiencies and allows for data reuse while helping streamline tasks and processes that are critical to any clinical trial. Unlike other CTMS, MasterControl Clinical Suite does not focus only on collecting information and documentation. It has capabilities such as quality and risk management. Other prominent features include study, site, project and vendor management, electronic trial master file management, document exchange and third-party collaboration, among many others. These and more make up the reasons why the platform is trusted by over 1,000 organizations worldwide.

4. EXPeRT eClinical

EXPeRT eClinical is a clinical trial management platform that is targeted at organizations who are looking to improve their trial processes. The software significantly speeds up time-to-market with the use of real time analytics, trial management, risk management and business intelligence. It provides users with visibility over all aspects of clinical trials by integrating all relevant clinical and operational data. The solution also has the ability to manage risk, allowing you to confidently get on with your trials by providing access to trial performance in real time. Collaboration among stakeholders, sponsors and CRO are also promoted with the shared visibility that the system provides. Whereas your average CTMS takes a silo approach in risk management, which results in efficiencies and additional costs, EXPeRT eClinical does this in real time, offering protection and total control over trials.

5. BioClinica CTMS

BioClinica CTMS is a web-based clinical trial management software that has the ability to transform clinical trials into a highly-efficient work environment. This is made possible with the software’s integrations with SharePoint and other products from Microsoft. The system offers users total control over trials, bringing efficiency and quality information to any scientific study. It likewise provides real time operational visibility. The platform can link trials to data using Outlook quite easily, promote collaboration using SharePoint and export information to Excel. These data exchanges are seamlessly accomplished, making Bioclinica one of the most powerful solutions of its kind. Even novice users require minimal training in using the system as all interactions occur in Microsoft tools, which just about everyone is familiar with.

6. Ofni Clinical

Ofni Clinical is a clinical data management solution designed to help researchers create databases that are compliant with 21 CFR 11, Annex 11, and HIPAA regulations. Equipped with data capture, electronic CRF, automated data querying, and data validation, this platform will surely help you make your clinical studies more accurate and efficient than ever. It even has an intuitive user interface that makes it easy to learn and implement even for research professionals who do not have extensive technical know-how. What truly makes Ofni Clinical stand out, however, is that it can match your case report forms. This makes it highly adaptable to your existing workflows. It even has strict data cleaning, data validation, and edit check functionalities so you can identify any questionable data entry that may negatively affect the results of your study.


CANTAB is a cloud-based digital cognitive assessment and eCOA created by the Cambridge Recognition. It quantifies cognitive performance and impairment in a non-invasive manner in order to help you manage cerebral health as effectively as possible. With it, you get access to language-independent parallel modes and stimuli randomization so you can yield more accurate evaluations regardless of what language your subjects speak. Apart from its innovative approach to cognitive research, CANTAB is also built to accelerate research lifecycles. It leverages computerization and automation to administer and score tests. After which it syncs your data in a centralized database. This way, you don’t have to worry about any information falling through the cracks. It even backs up your data regularly to ensure research continuity.

8. OpenClinica

OpenClinica is an open-source clinical data management and electronic data capture system. It comes with an easy-to-use drag-and-drop interface that lets you design studies, perform real-time edit checks, as well as manage supplies at a granular level. What’s more is the platform meets GCP and 21 CFR Part 11 regulations and has validation documentation and audit support. OpenClinica is also intuitive enough to help you drill down into your study data. It has extensive data visualization tools that let you format results using bar charts, line graphs, or any other graphic that you prefer. It also allows you to create advanced queries so it is easier to review findings as well as correct errors quickly. Lastly, as an open-source system, OpenClinica is highly configurable and scalable as it can integrate with other business systems via SOAP and RESTful APIs.

9. Clinical Research IO

Clinical trial management software Clinical Research IO helps members of the life sciences sector in managing all aspects of their trials. It can handle just about everything, be it curating your patient database, tracking your finances or integrating your operations with the solution. Scheduling is no problem with the platform, letting users schedule subject visits and change calendar entries using subject profiles as basis. As the platform is deployed via cloud, being on the go is no problem at all. The system can be accessed anytime, anywhere, relieving users of paper binders. Other key features include receivables tracking, invoicing, voice over IP line and pre-screening and qualifying patients using recruitment profiles.

10. LifeSphere CTMS

A total clinical trial management platform, LifeSphere CTMS allows members of the life science sector to manage activities from planning, tracking and controlling tasks relevant to clinical trials. The software is highly-configurable, providing users with total visibility into all trial activities, ensuring transparency. It basically automates key processes, which include, planning, site assessment, enrollment planning, investigator selection, distribution of documents and site visits. The platform complies with all industry best practices in streamlining study implementation. With the system, CRAs are able to monitor all site documents and patients, track trial payments and route visit reports using a workflow-driven and automated process of review and approval. All final documents can be stored safely in the system’s electronic trial master file.

Features to Look for in a Clinical Trial Management Software

Here, we take a look at the top features that one should look for in a CTMS and how they can give clinical trials that much-needed boost.

  • Investigator Performance. Every CTMS comes with an investigator profile, which carries with it information that include name, addresses, licenses, degrees, therapeutic areas and specialties. Current platforms make use of investigator profiles in tracking recruitment and compliance. This aids in the search for high-enrolling partners, which can subsequently be promoted to a study. This central database is seen as an asset in establishing strong relationships.
  • Site Communication. What’s good about CTMS is that they provide visibility into study sites across a variety of channels, which provides users with the gift of oversight. They help in planning site visits as users are provided with a view of dialogue history. These communications include matters such as monitoring and safety letters, technical issues, start-up documents and payment inquiries. CTMS should also be able to integrate documents with portals and manage service levels with the use of workflows, automated notifications and escalations.
  • Mobile Optimization. It is no secret that most of those who work on clinical trials are always on the go, your CTMS should be mobile optimized to cater to these smartphone and tablet-wielding professionals. While it’s true that the laptop synchronization options exist, their adoption rates remain low to date.
  • Workflows. With the biotechnology and pharmaceutical sectors’ engagement in risk-based processes, workflows and triggers have become requirements. Aside from this, workflows are very helpful in creating site interaction, information requests and moving on to the next process.
  • Payments. To maintain efficient investigative sites, CTMS must be able to come up with site payments accurately and in a timely manner while being able to effectively manage terms of contract. Despite the fact that focus on investigator payments as a CTMS functionality has been placed on the backburner, it remains essential with respect to the introduction of regulations like the Sunshine Act, which highlights the role of payment engines. It is likewise still much preferable to the prospect of exchanging huge amounts of information between different platforms.
  • Cloud Deployment. Early CTMS platforms were deployed on-premise and were based on object-oriented programming, offering little or no scalability. Today’s cloud-deployed solutions offer scalability and are much more inexpensive. They can be rapidly deployed and bring with them numerous tools for use by both internal and external staff and partners. This enables users to exploit such systems in far more clinical scenarios than ever before.
  • Managing Resources. The importance of assigning staff to clinical trials based on skills, languages, availability, location and experience can never be stressed enough as they play a critical role in achieving both country and study-level milestones. Recruitment efforts can be driven through resource allocation and demand forecasts.

With the benefits that IT technology has to offer clinical trials, CTMS has most likely made it to every pharmaceutical and biotechnology companies on the planet. If you are a clinical trial manager looking for the perfect CTMS, there are a few things to consider in such a solution. Review the features to look for in CTMS to make sure the software you choose is perfect for your specific needs.

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