Many industries are already adopting emerging technology practices, including the healthcare industry. With the many processes and tasks involved in a healthcare organization, especially when it comes to data handling, it is crucial to implement a strategic plan or innovate some concepts that will streamline the processes, ensuring accuracy and the right procedures are followed. A clinical trial management system, in this case, will facilitate the processes and measures put in place to improve the patient care procedures and overall research processes.

That is why this guide digs deep into what a CTMS – clinical trial management system is, its core features, why every healthcare organization should have one, and how to develop such a system, among many other insightful concepts.

What is a clinical trial management system? Quick Overview

A CTMS-clinical trial management system is a software solution that facilitates or simplifies the processes of managing all the research activities in an organization.

The software solution offers a streamlined platform to help the teams in planning, processing, and controlling all the clinical trial processes. The activities that are simplified with the CTMS include financial tasks, streamlined collaboration & communication, collecting data, and regulating files within a healthcare organization.

In a nutshell, a CTMS enhances the following tasks within an organization:

• Enhancing the management of the study subject
• Creates a seamless environment for patients on clinical trials
• Accelerates execution and research timelines
• Creates a simplified billing process and compliance
• Facilitates productive research reporting
• Facilitates financial management of research dealings

Features of a clinical trial management system

There are many software systems within the healthcare industry. However, these software solutions differ in their significance within a healthcare institution. The unique features distinguish different software solutions in the healthcare industry. In this case, the following are features that define a CTMS:

• Reporting & Analytics

The reporting and analytics feature in a CTMS helps the teams evaluate the insights on the trial proceedings to make practical decisions. In fact, a solid and reliable CTMS has the potential to tailor and customize the reporting tools and all the reports to align with the set standards and regulations within an organization. You can also include data visualization tools to enhance the system’s functionality, especially when analyzing complex datasets.

Through analytics, you will be able to track the emerging trends and practices in the industry and adopt them seamlessly.

• Regulatory compliance

The healthcare field has specific rules and guidelines organizations must follow, especially in clinical research. Therefore, include a feature in your CTMS that manages your files when approving and submitting to ensure all the regulatory compliance is in order.

What’s more, you can easily track the required compliance progress, the procedures to follow, the consent, and any changes needed. You can then update all the emerging regulatory requirements promptly.

• Clinical research management

The CTMS should have a central center for processing the daily activities of the clinical tasks. Such a feature helps the teams perform clinical-related tasks each and every day, including managing the clinical research processes, monitoring regulatory compliance & documents, providing an easy-to-navigate plan that allows users access files, and finally, managing all the financial and billing requirements in relation to the clinical research activities.

• Billing compliance

You will need to include a streamlined billing process in your CTMS, including managing and tracking invoices. The feature is crucial in helping the teams complete their billing processes, which facilitates a seamless clinical research process.

• Patient enrollment and randomization

In a clinical trial setup, patient enrollment & randomization are inevitable to complete the process successfully.

With a reliable CTMS in place, it becomes easy to automate processes such as screening the patients, checking eligibility, and the randomization processes.

Integrate this feature into your system to provide real-time analysis or progress into the patient enrollment procedures. The data collected facilitates making informed decisions.

• Financial management and budgeting

Apart from the billing feature for the invoices, you will also need to integrate a financial management and billing feature into your CTMS to facilitate the processes of budget planning, expense management, and balancing study finances with vendors and study sites.

Don’t forget about the financial reporting tool to help optimize costs and mitigate potential financial risks.

• Data collection & monitoring

Data collection and monitoring are an integral part of clinical trial processes. That is why you will need to integrate a feature that will facilitate the entire process, ensuring everything aligns with the set procedures and standards.

Some of the functionalities of data collection & monitoring features include remote monitoring, verifying data sources, and collecting data from different sources like EDC – electronic data capture and ePRO – electronic patient-reported outcomes or results.

Integrating your CTMS with different data collection platforms to enhance and speed up the process of verifying data quality and identifying possible issues with different data sets.

• Integration & interoperability

You will need to integrate your CTMS platform with other systems to enhance its functionality and overall performance. For instance, integrating safety database systems, LIMS – laboratory information management systems, and EHR – electronic health records in your CTMS system creates a streamlined workflow and processes.

With a solid integration capability within your CTMS, you will enhance a better collaboration, facilitate data accuracy, and reduce data silos.

• Study setup and configuration

In a clinical trial setup, you will have to regularly setup and configure the system to accommodate new studies, hence the need to include a study setup and configuration feature; the procedures involve highlighting the new study requirements that include all schedules, criteria for inclusion & exclusion, among many other considerations within a clinical study set up.

You can also generate study templates with this feature to facilitate consistency throughout the trial period. The feature also helps the study teams to lay a strong foundation when starting and managing their study process to the end.

• Security

You will also need to integrate the security feature that will facilitate the processes of monitoring data security, sending alerts in case of a potential security risk, offering secure storage facilities, facilitating data access processes for security, and facilitating the use of strong passwords & multi-factor authentication.

• Issue management

This feature will facilitate the process of resolving an issue in accordance with good clinical practice. Among the issues in a clinical trial management system include not following the set protocols, failure to adhere to the set ethical standards, violating patient safety, and any other issues relating to specific countries, study levels, or issues with the platform.

Benefits of a clinical management system

So, why would an organization need a CTMS in their facility? Some of the top benefits of implementing a clinical trial management system include the following:

• Enhances seamless collaboration

Updating and briefing your team members regarding the study can be complex and time-consuming, and it is possible you can forget some of the crucial details when briefing your teams physically. However, with a CTMS platform, you can easily collaborate with all the team members, send updates when necessary, and update them on all the activities. It is also easy to track and monitor the progress of ongoing tasks, with each team member contributing towards a successful project completion.

• Facilitates access to updated and accurate data

In a healthcare setup, especially on matters of clinical trials, accessing updated and accurate information is vital in making informed decisions. Besides, access to updated and accurate information helps the team members overcome any challenges that might crop up during the clinical trial processes.

It can be complex, challenges and time-intensive trying to access the updated and accurate information during clinical trials. However, with a CTMS, all the processes are simplified and made easy. Through the software solution, you don’t need to keep records as you keep tracking updated information. You will access all the study information in a streamlined manner and make informed decisions in a timely manner.

In fact, the higher level of transparency in a CTMS creates a better platform to access information, which helps the team make decisions for enhances productivity.

• Reduced human errors

When dealing with management tasks especially where paperwork is involved, errors are inevitable in this case. Errors can impact the clinical trial processes negatively, including monitoring reports and collecting documents, among other related procedures under clinical trials.

However, a reliable CTMS offers a clear dashboard and data reports that provide a clear overview of the studies’ scores and visualizations of all the processes involved. This limits or eliminates some common errors from occurring during the procedures, thus enhancing a higher level of accuracy.

• Efficient study management

The clinical trial is a process that undergoes several procedures, including data collection, enrollment and recruitment of participants, and study closure, among many others. All these processes require a streamlined management process to ensure every step is finalized accurately and in a seamless manner.

In this case, a CTMS has reliable tools that enhance the completion of every stage accurately and professionally.

• Helps in making informed decisions

One of the major reasons making a CTMS platform stand out is the fact that it helps the teams make viable decisions. With solid reporting and analytics tools, the platform helps the teams review the insights and the overall system performance, which helps them make informed decisions.

This is especially important when making decisions in accordance with the emerging trends and practices in the clinical trial field.

• Streamlined workflow

By facilitating a smooth working environment, the CTMS reduces manual work, giving the teams adequate time to focus on other activities that will increase productivity. Besides, task automation minimizes any associated risks plus saves more time, thus creating an accommodating and productive working environment.

• Streamlined Participant Recruitment and Retention

It can be challenging when it comes to onboarding and retaining participants in clinical trial procedures. However, with CTMS, it becomes easy to integrate recruitment and participant databases to streamline the processes.

The automated screening process facilitates matching ideal candidates depending on the set criteria, making the entire process easy and straightforward. What’s more, the personalized communication feature fosters trust and transparency among the participants, thus keeping them committed and engaged to complete the trial processes.

• Regulatory compliance

The clinical trial is a delicate field with strict guidelines and rules, hence the need to follow them strictly.

A CTMS has tools that facilitate paperwork automation, secure record management, and streamlined communication by following the set regulations.

Besides, the clinical trial management system fosters data accuracy and sets clear guidelines, which eliminates risks associated with non-compliance. This helps the teams set a clear path to inspect the regulatory requirements in preparation for approvals.

• Saves costs

While CTMS offers efficiency, it helps facilities save more by optimizing resources during the clinical trial procedures.

For instance, the system automates manual tasks, thus allowing appropriate resource allocation and accelerating the processes. This creates a smooth operational environment while promoting strategic approaches to medical research, which facilitates the success of the entire process.

How to build a clinical trial management system

We’ve explored all the reasons why a clinical trial management system is a viable solution for streamlined processes and a strategy to save on costs by optimizing resources. However, the main concern is how can you develop a fully functional CTMS?

The process involves a strategic plan and steps to follow to ensure the final software solution meets the defined guidelines and requirements. Here is a step-by-step guide on how to build a CTMS:

• Planning and conceptualization

Start the process of building a CTMS by conceptualizing and planning effectively. You need a clear vision and objectives you need to achieve with the software solution. As you plan and conceptualize the whole matter, work with clinical research experts to ensure you don’t miss out on a single concept.

Under this stage, think of the following:

• What are the researcher’s challenges?
• What measures can you take to solve the existing challenges?
• How will you collect data and perform analysis with the available technology?
• What are the set rules and regulations for the clinical trial management system you want to build?
• Do you need specific experts to complete the process?
• What is your budget?

These are among the many questions you should consider before starting the CTMS development phase.

You can then figure out how you will address real issues affecting the clinical trial field by using appropriate technologies to build the software solution.

• Collecting the requirements

After you’ve planned, you have a clear overview of what you need to create the software solution and address all the issues affecting the clinical trial field.

Here, you work hand in hand with the stakeholders by conducting workshops, surveys, and interviews with regulatory bodies, sponsors, clinical researchers, and other users.

Define the gaps and expectations at this stage to ensure that you build a system that meets all the requirements. Don’t forget to document a procedure or roadmap to follow during the actual development process once you have all the requirements.

• Design & prototyping

At this point, you already have a detailed roadmap. However, before you build the software solution, do the design and prototyping as you collect user feedback. The process involves creating intuitive interfaces to enhance user experience.

You can then implement changes as you modify the design to align with user preferences based on the feedback collected.

With design and prototyping, you will build a design that will fulfill user needs while enhancing efficiency in operations.

• CTMS development

After designing and prototyping, you have everything in place to build the actual clinical trial management software solution. The frontend development team will use appropriate tools and technologies to build an easy-to-use and responsive user interface, while the backend development team will use the right tools & technologies to develop the system logic, database, and server development.

Another key task during CTMS development is the integration with other systems, including clinical trial registries, regulatory databases, and EDC – electronic data capture. The integration of these systems enhances the system’s performance and overall functionality, ensuring every process within the clinical trial is completed successfully.

• CTMS testing

Once your system is complete, there is more work. You need to test the functions and features of the system to ensure efficiency during operations. You will, therefore, need to perform user acceptance testing, overall system testing, integration testing, regulatory compliance testing, and unit testing. These processes ensure the software solution is reliable, secure, and fully functional, ready for deployment.

• Deployment

After verifying the system’s feasibility through a series of tests, you can now plan to deploy or launch the system.

Start by preparing the live environment, transferring data, and setting all the processes in a real-world environment, ready for use.

Monitor the system as you launch it to identify and resolve any possible issues that might arise. Finally, train all users on how to use the system effectively.

• Regular updates, maintenance &support

This is the last step in the CTMS development process. You need to regularly monitor and update your CTMS in relation to the changing regulations, if any, add more features in accordance with user needs & preferences, and offer continuous support to users as you address any issues that may arise in the system.

Regular updates, maintenance, and support to the system ensure it lasts longer and performs well throughout.

What is the cost of developing a clinical trial management system?

The cost of developing a clinical trial management system isn’t a fixed price. It is dependent on the complexity of the software solution, the number of features, integrations, and the type of development team, among many other factors.

With this in mind, the cost of developing a software like clinical trial management can be as low as $50,000 and as high as $500,000, depending on the aforementioned factors.

Clinical trial management development best practices

If you want to get the most out of your CTMS software solution, then do the following:

• Define user needs – do some research on the clinical trial and understand the challenges clinical researchers, sponsors, regulatory bodies, and trial coordinators, among other users, are facing. Don’t forget to involve the users during the research process as you interview them on their challenges and how they would wish their issues to be solved.
• Create s flexible and scalable system – Make sure the CTMS can handle different data types for a seamless operation. Clinical research handles a wide range of data, including imaging data, laboratory results, patient-reported outcomes, and electronic health records, among many others. As you create the system, make sure it can accommodate all these types of data.
• Real-time monitoring and reporting – including reporting tools and an interactive dashboard into the CTMS to monitor processes such as data quality, patient enrollment, and trial progress to enable the teams to access accurate data on time.
• Prioritize safety and event management procedures – including tools that will facilitate the process of capturing and monitoring data safety and adverse events during clinical trial procedures. This will help the teams report any events to the relevant authorities and ethics bodies for immediate solutions.

Emerging trends and technologies in the clinical trial system development industry

Some of the trends and technologies that are set to elevate clinical trial management development include the following:

• Patient-centric solution – the trend is all about focusing on enhancing participant experience by putting in place mobile apps, creating user-friendly interfaces, and remote monitoring functionalities.
• EHR – electronic health records integration – this technology facilitates data exchange between researchers and health providers for a streamlined and quick clinical trial procedure.
• The use of mobile apps & wearable devices – this trend helps researchers collect real-time information remotely from participants for appropriate decision-making processes.
• Telemedicine and virtual trials – this trend helps researchers monitor remote participants, execute electronic data capture, and achieve virtual visits without necessarily engaging with participants physically.
• Blockchain technology – this technology helps safeguard all the data involved in clinical trial procedures.

Conclusion

In the process of enhancing efficiency, accuracy, and innovation in the clinical trial field, a CTMS is a crucial resource. It ensures all the processes are in place, automates several tasks, minimizes risks & errors, and guarantees regulatory compliance, among many other benefits.

By integrating relevant systems and including advanced technologies, the concerned parties handle the medical processes in a professional manner and faster for that matter.

As you plan to build a CTMS for streamlined operations, think of the bigger picture. What do you need to solve with the software solution? What is the future of such a system? Yes, it can be a complex process, but with experts from Aalpha Information Systems – a leading healthcare software development company – you can be sure to get a flexible, scalable, and fully functional CTMS tailored to align with your unique needs.