A clinical trial management software, also known as CTMS (Clinical Trial Management System), handles processes, operations, and data involved in clinical trials and studies. A CTMS centralizes all trial and research data, streamline workflows, and optimizes trial processes. Research centers, pharmaceutical companies, and medical research centers use this software to carry out trials seamlessly.
Clinical trial management software is gaining newer heights in current market conditions, as per a report the CTMS market is anticipated to reach $2,810.5 million by 2030, surging at a CAGR of 11.2 percent during 2021-2030 timeframe.
Read on to know more about CTMS and ways in which it can benefit a healthcare organization or research institutions.
Benefits of Clinical Trial Management Software
1. Reduction in Human Errors
To err is human. Humans are bound to make mistakes and oversee some crucial aspects of research. This impacts the overall clinical trials, including documentation, data collection, calculations, etc.
However, human errors can be avoided by incorporating clinical trial management software, as this gives viable data reports, and provides visualization for all clinical studies.
A CTMS offers complete transparency on all critical components of research, such as site visits, screening, enrollment, study startup, report monitoring, issue management, and more, thereby reducing human errors.
2. Easy Collaboration with Teammates
Whether managing research facilities or conducting research, teammates or colleagues are required to work with each other and other organizations to successfully finish trails.
Simultaneously working with various research departments, organizations, and a team can get complicated, keeping in mind the amount of work on a plate.
With no central co-ordination in place, managing it all becomes difficult. Therefore, with clinical trial management software, researchers, teams, and organizations can stay on top of each other, resulting in timely and accurate trial completions. Teammates can collaborate on one task for same study, with a confidence that all are processing latest data.
3. Access to Updated Data
To manage clinical trials, researchers and medical professionals need access to updated and accurate data. Updated data helps them to make informed decisions and plan out future course of action accordingly.
At times, its difficult to get hold of high-level data and keep updating it continuously. Therefore, clinical trial management software is used to overcome this obstacle. It takes away the hassle of maintaining information constantly.
Key Features of Clinical Trial Management Software
1. Security
A CTMS is required to adhere to regulatory compliance, in this regard its HIPAA (Health Insurance Portability and Accountability Act). HIPAA safeguards all vital medical data and has fix set of protocols for disclosing crucial medical data.
Additionally, CTMS must adhere to title 21 of the CFR (Code of Federal Regulations) Part 11, which states that all electronic signatures, electronic data, and handwritten signatures converted to e-records are reliable, trustworthy, and equivalent to paper records.
Title 21 is essential for documentation that requires signatures from higher authority and all research data.
2. Documentation Tracking and Management
Documentation, whether on paper or electronic is an essential part of a medical or research organization. Documentation tracking helps to regulate status of clinical trial throughout its lifecycle.
Additionally, it reviews and manages all important study documents for seamless trials. Documentation tracking increases productivity, as researchers know where to look for a desired data.
Efficient and fast document retrieval saves time and energy, along with surging customer satisfaction. Further, document management ensures a better backup and recovery plan in case of crisis or natural disasters, thus preventing loss of valuable data.
3. Clinical Trial Project Management
This feature contributes to the overall management of clinical trials. It oversees timelines, project activities, and resources. Project management feature helps to communicate with a team and track progress at all levels. Additionally, it helps to track submissions and coordinate activities amongst all departments.
Issue management falls under this as well; it ensures that all problems are resolved as per GCP (Good Clinical Practice). Further, clinical trial project management supports clinical monitoring, and ensures that trials are conducted as per safety and ethical standards.
4. Data Management
Clinical data management is a vital phase, which leads to the creation of reliable, statistical, and high-quality data from clinical trials. Data management in CTMS provides assurance to researchers that they’re collecting and managing data appropriately.
Software developers can consider including remote data management feature in CTMS, for organizations that have several trial sites.
Further, integration of AI (Artificial Intelligence) in data management feature can support critical decision making, process automation, and data analysis. Additionally, data management balances lead time and risk reduction, through useful insights.
5. Site Management
This feature includes –
a. Handling trip reports and site visits
b. Providing subject enrollment and site monitoring
c. Tracking and defining responsibilities of all participants in a clinical trial.
Guide to Developing a Robust Clinical Trial Management Software
Rise in research and development expenses, and clinical trials is resulting in the adoption of clinical trial management software. While choosing to develop a CTMS, consider evaluating through the following aspects –
1. Study Needs
Understand study needs prior to finalizing a CTMS for an organization. Prioritizing study needs allows to detect a solution that surges the quality of a research study and eliminates all doubts faced by researchers.
Consider choosing a CTMS helps to deal with site centers for clinical trials. Choose a CTMS that allows to enter data consistently and intuitively, plus is well-organized, easy-to-use, and is designed to finish tasks quickly.
2. Scalability
A scalable CTMS allows to easily keep up with the varied types of trial demands, while maintaining costs and assuring better agility. Scalability ensures improved and secured data storage, along with enhanced end-user experience.
Furthermore, with cloud, scalability becomes fast and easy, there’s no delay of services. A scalable CTMS solution is capable of handling data and growth requirements, allowing research or medical organizations to grow.
3. Multiple Integrations
Multiple integrations assures easy transitions between data gathering and site operations, thereby making clinical trials more seamless. Choose clinical trial management software that can integrate well with complex research study process. Furthermore, use simple integrations for systems to work flawlessly and effectively.
At the beginning go with small and straightforward integrations, as it doesn’t create any dependencies when compared with complicated or larger solutions.
That was all about clinical trial management software.
To know more about it, and to develop healthcare software solutions for your organizations, connect with Arkenea, which specializes in healthcare software development, and has over 11 years of experience in the same field.