The medical research teams that conduct clinical trials have the weight of the world on their shoulders. While advancements in the medical field have enabled better, easier, and more affordable access to medications, the road to each new drug’s approval can be long and labor-intensive. Once a new drug is discovered and developed, it must undergo an intensive pre-clinical and clinical research process before being brought to entities, such as the FDA, for review.
From researchers to patients, doctors, and nurses, thousands of people are involved in every clinical trial. This leads to massive amounts of generated data, all of which must be appropriately managed. Proper data management ensures the health, safety, and privacy of patients participating in the trials; and for future patients who might take the medication at a later date.
Clinical Trial Management Systems (CTMS) streamline the processes involved in logging and maintaining clinical trial-related data so that the research team can securely store all patient information in a single, centralized location. They help users avoid the human error associated with manual process management that can snowball into data mismanagement, misinterpretation, and negligence.
In this article, we’ll look at the need and benefits of CTMS software. Then we’ll review eight best-in-class CTMS solutions that are proven solutions for successful clinical trial management.
What is clinical trial management, and why use a tool for it?
Clinical trial management can be defined as documenting and evaluating all data and processes involved in a clinical trial. Clinical Trial Management Systems are software solutions that support the research entities behind clinical trials. For easy access, planning, benchmarking, reporting, billing, and tracking of clinical trial data are all logged in a single location.
Processes covered by CTMS include:
- Product registration
- Dossier File and Binder Creation (document and binder)
- Registration and Submission
- Variation Management and Change Management
- Renewal Management
- Regulatory Correspondence Management
- Regulatory Commitment Tracking
CTMS solutions make the entire clinical trial process easier and more efficient to execute for the principal investigator, the research team, and pharmaceutical companies.
Key CTMS Features
The best-performing CTMS software integrates with business intelligence and/or analytics technology. It contains some or all of the following capabilities:
- Electronic data capture system
- Cloud-based software for remote storage, access, and retrieval
- Multi-layer data, site, subject, and investigator management
- Financial analysis
Additionally, these solutions comply with relevant regulatory requirements in diverse geographic locations. They can be tailored to meet specific segments and sectors’ needs within the larger medical research industry.
While point solutions for CTMS exist, a platform solution is preferable to truly eliminate silos, integrate with other quality and compliance processes, and enable better visibility across the entire clinical trial process. A CTMS that is part of an overall QMS solution enables better flexibility and scalability as the clinical trial evolves; and provides more robust and reliable results.
Top 8 Clinical Trial Management Systems
Dot Compliance is a QMS solution provider for clinical trial management that combines CTMS with QMS to holistically manage and optimize clinical documentation, quality, compliance, and risk. With Dot Compliance, all stakeholders can seamlessly manage and track the entire clinical research and trial process with a centralized solution. It ensures easy access and collaboration of all parties to study information, ETMF (Electronic Trial Master Files), clinical documents, and tasks.
Pricing information is provided upon request. A free trial is available.
What users say: “The support from the vendor has been outstanding, right from the time we started learning the system and migrated our policies and procedures.”
IBM Clinical Development is a global, cloud-based SaaS solution. It offers unified data capture capabilities and a holistic view of critical trial data to clinical researchers of all kinds. This CTMS comes with patient engagement modules and data integration, automation, randomization, and trial supply management tools.
For more information on the quote-based pricing model, contact the vendor. No free trial is available.
What users say: “The system offers a modular approach, so you can select (and pay for) only the modules you want. On the downside, some of the modules are must-haves, and you have to pay for them when other systems include them in the base fee.”
Castor Electronic Data Capture (EDC) is a cloud-based electronic data capture solution for healthcare, biotech, medical device suppliers, and pharmaceutical researchers. The software enables high-quality data collection, and its API allows custom integrations as needed.
ricing starts at approximately $410/year for non-commercial applications and $1,229/year for commercial applications. A free trial is available upon request.
What users say: “Thanks to the number of functions that this system has, my team has been able to be efficient in their respective tasks, since it has been possible to optimize delivery times for clinical studies, leaving clients satisfied with the work done.”
A web-based CTMS, Bioclinica presents a solution for any entity conducting clinical trials. Minimal training is required to use Bioclinica’s CTMS. The user-friendly solution unites investigators, sponsors, and CROs for efficient and effective clinical trial management.
Contact the vendor for updated BioClinica pricing information. No free trial is currently available.
What users say: “Sometimes, it stuck during data migration, but great customer service; they provide support in different languages to resolve any issue.”
Developed by Bio-Optronics, Clinical Conductor is a cloud-based solution. It includes a finance suite, patient compliance application, study management, and results reporting capabilities. Clinical Conductor has eight applications designed to help recruit new patients to studies, remind them of appointments, and boost their retention.
Quote-based pricing plans are available for commercial and enterprise clients upon request. No free trial is available.
What users say: “There seems to be a feature for literally anything you could think you want, and the problem with that is that you often have to click around a lot to get to the places you need to go. Once you have it figured out, it’s a little easier, but at first, CC is clunky.”
nQuery is a web-based platform that can also be deployed on the Cloud or as a SaaS solution. The adaptive clinical trial software enables better statistical efficiency in response to live data, allowing for earlier decision-making and lower overhead costs. The system’s sample size calculator can be used to calculate a multitude of scenarios rapidly. Calculations are communicated to other members of the research team.
Various pricing plans are available ranging from $645/user/year (Base) to $6995/user/year (Expert, beta version). See the vendor’s website for more information.
What users say: “It has a broad selection of tools in calculating sample size and power. The menus are easy to follow and the help icons on each screen help you navigate very well through the calculation. Great for academics and able to take some detail in its calculations.”
The ClinPlus suite unifies electronic data capture, statistical reporting, data disclosure, medical coding, and more into a single platform. It has a single sign-in and a user interface that can be tailored according to specific roles. A secure, private cloud covers the entire clinical trial process and monitors visit reports. Users can quickly transfer data to Word, Apple, and Google Docs applications.
Pricing and a demo can be requested from the vendor’s website.
What users say: “We conducted a consolidated review of 10 Clinical Trial Management Systems prior to selecting and implementing ClinPlus. Clinplus was the closest match for our requirements, with a great balance of features, usability, and value for money.”
OpenClinica’s electronic data capture, patient-reported outcomes, and reporting capabilities are just some of the open-source clinical data management system‘s features. The data visualization tools enable real-time edit checks and granular-level clinical data management. Open Clinica allows deep study of clinical data, scaling and integrating the system with other business systems, and compliance with GCP and 21 CFR Part 11 regulations.
Contact the vendor for updated pricing information for their Community and Enterprise offerings.
What users say: “The way patient data is displayed is very easy to navigate – instead of selecting a subject and then a visit, all subject visits are displayed in a grid. Each visit is also color-coded to indicate the completion status of the form. However, viewing, answering, and resolving queries is not user-friendly.”
Clinical trials involve massive datasets and multiple team members, leaving the possibility for errors always in the air. Adopting the right clinical trial management software can help streamline processes and eliminate associated human error. To further elevate the practices and results of your next clinical trial, consider a CTMS that is integrated with a cloud based QMS. Together, these two powerhouse solutions eliminate silos and can generate better results on larger samples, end-to-end, with greater speed and ease.