What is a CTMS and how is it used in clinical trials?

Clinical Trial Management Systems (CTMS) are a type of software used to manage clinical trials. They are a central end-to-end solution for managing all aspects of a clinical trial from study start-up to close-out across multiple sites. Here is what we will cover in this article:

How is a CTMS used in clinical trials?
What are the main features of a CTMS?
What is EDC and how is it different from CTMS?
What are the benefits of using a CTMS?

How is a CTMS used in clinical trials?

A CTMS is used as a project management tool in clinical trials. This system helps clinical research teams effectively plan, manage and track a clinical trial. A CTMS is used from study start up, through the execution of the clinical trial, to the close out of a study. Most pharmaceutical companies or other organizations which sponsor clinical trials use a clinical trial management system to manage their clinical trials.

A clinical trial management system can help with many aspects of clinical trials, such as:

Clinical trial timeline planning and milestones
Managing patient recruitment campaigns
Collecting data from research sites and monitoring adherence to protocol guidelines
Generating reports that summarize findings and suggest next steps
Managing study data, including subject enrollment and recruitment records, study visits and assessments, and other components, throughout the data lifecycle (from collection to storage to sharing)
Archiving research data for long-term storage and future use
Data integration between multiple sources
Data analysis tools
Managing ethics and the trial approval process
Managing study documentation, including case report forms, informed consent forms, and other documents
Managing reporting tasks

What are the main features of a CTMS?

The complexity of CTMS varies depending on numerous factors specific to the unique trial being conducted, but all clinical trial management systems share some common features and abilities, including:

Data collection (from participants)
Data input (from staff members or research associates)
Data analysis via an automated system
Data management, including the ability to view and manage data from multiple studies
Reporting tools that allow staff members to create reports based on data that is entered into the system
Preparation of reports for reporting results and safety data to sponsors, the FDA or other regulatory bodies
Data archiving and retrieval
Data export to external systems, such as the FDA’s database
Assistance in monitoring of the study by an independent review board (IRB)

What is EDC and how is it different from CTMS?

An electronic data capture (EDC) system is software that stores all clinical information about patients participating in a trial—from demographic details like age and gender to information about their medical history and current condition(s). EDC systems can also be used to track how well each patient responds to treatment over time and whether they experience any side effects from a drug/treatment. CTMS on the other hand, are comprehensive management tools used to manage the entire clinical trial. EDC and CTMS are complementary products and clinical trials will usually use both systems.

What are the benefits of using a CTMS?

In this section, we go over some of the benefits that the use of clinical trial management systems can bring to clinical trial sites.

1. Operational efficiency

The process of managing a clinical trial can be extremely time-consuming, especially if the trial involves multiple sites across different countries. Many of the management tasks can be automated or otherwise streamlined by using a clinical trial management system, allowing sponsors and researchers to focus on other tasks they specialize in.

A CTMS can help streamline operations by allowing for easy access to information across trial sites and for different personnel, and can reduce the time it takes to complete tasks.

2. Data accuracy and availability

Using a CTMS in clinical trials significantly decreases the chance of errors that can arise when inputting and tracking information manually. Using software to manage data can help ensure the data is robust enough to support conclusions, and thereby improves the chances of the trial drug/treatment being approved. A CTMS also provides a central place for all data and this data availability improves decision making.

3. Compliance

A CTMS provides assurance around data integrity and record-keeping which are critical for all clinical trials. The data analysis capabilities of many CTMS can also be used to keep track of adherence to protocol or can automatically alert the team to any potential safety issues that are detected based on the data collected, helping to ensure compliance with regulations set by the FDA (or the relevant authority in other countries).

Conclusion

Considering their strategic importance, it is not surprising that clinical trial management systems are becoming more popular and are constantly being improved. A CTMS can provide major benefits in streamlining operations, ensuring data security and consistency, managing documentation, and keeping accurate records of their activities. Overall, a CTMS supports a trial in being conducted efficiently.