Clinical data management (CDM) and clinical data management software (CDMS) are critical to the success of clinical trials for healthcare organizations. Take a look at the following overview of the different types of CDMS systems, the features of most CDMS systems, and how to choose the right one that fits your needs.
What Is Clinical Data Management Software?
Generally, a clinical data management software system is a software application that enables clinical researchers to perform various tasks in clinical data processing (CDP). The system typically includes the following:
- Data coding and analysis
- Source document verification (SDV)
- Source document management (SDM)
The primary function of clinical data management software is to produce accurate data. This goal is achieved by executing quality checks and cleaning data. The system checks data against standard dictionaries to find term matches. When data doesn’t match, the system flags items for further verification.
CDMS enables researchers to combine data from multiple sources and report continuously, which helps increase the time to market for a new drug. It also provides the foundation for error-free data collection by automating data coding and error checking.
In addition, CDMS helps with patient recruiting efforts. It is also useful in developing patient registries. A CDMS can be customized for drug development, psychiatry studies, and medical device clinical trials.
A CDMS also helps investigators collect and enter data in a form similar to a hospital chart. The interface makes it easy to enter data and perform SDV. It also provides comprehensive query management.
To use a CDMS, it can be a standalone system or integrated into a CTMS (computerized trial management system). Some CDMS systems are paper-based, but software versions are far more accurate and reliable.
What Are the Features of Clinical Data Management Software?
Choosing the right clinical data management software for your needs is critical for generating reliable data.
- The CDMS should be able to meet all regulatory requirements and provide the necessary features and functionality.
- The system should be able to capture and store data.
- The CDMS should be capable of performing coding, error checking, and mapping.
- Discrepancies should be identified and resolved with documentary proof and an audit trail.
In the past, paper-based questionnaires were used to collect data. Data was entered on the CRF form by the investigator. The data was then translated into the database and printed out. Human error was not uncommon, but an electronic CDMS can help identify discrepancies or possible errors.
Eliminating the risk of error is critical because clinical data management software must comply with 21 CFR Part 11 federal regulations. It also has to be validated against the stated guidelines. Because the software is generally designed by a third party, it’s essential to verify that the vendor’s software system complies with industry standards.
For example, the CDISC standards (Clinical Data Interchange Standards Consortium) are mandated by the U.S. Food and Drug Administration (FDA). These standards ensure interoperability and reusability. They have also been adopted by the world’s leading research organizations.
Most clinical database applications have built-in compliance with regulatory requirements. Some systems also allow users to import data from other sources, which is a good choice for onboarding investigators.
What to Look For in Clinical Data Management Software
There are a number of CDMS systems available for clinical trials. They range from open-source tools to commercially produced commercial software. Some systems are customizable to meet specific requirements, while others are standardized.
Supports Records Management
One of the most important components of clinical data management software is the management of electronic documents associated with a clinical trial. Proper records management is critical because regulatory agencies are moving towards integrated electronic systems, which is one of the main reasons for the rise in the demand for CDMS.
Ensures Accurate Data
Choosing clinical data management software is crucial to running a clinical trial. It must be accurate, secure, and reliable. The right system will help you reduce the time it takes from drug development to marketing. It will also ensure that your trial is ethical and that honest and accurate results are obtained.
Effective Use of Resources
A clinical trial requires a lot of time, money, and resources. Investing in a robust and reliable system is important to get the best return on your investment. Proper data collection will involve a multidisciplinary team, including clinical data managers, biostatisticians, research nurses, and support personnel.
Supports Your Preferences
When choosing clinical data management software, make sure the system checks the boxes you’re looking for in regard to specific features and functionality. Consider these factors:
- The number of desired users.
- The type of installation platform.
- Technical support.
- Quality of the user documentation.
- Availability of user training programs.
- Reputation of customer service (e.g. do they offer fast response times for issues?).
If your trial involves more than a few sites, looking at a system that offers 24-hour issue support may be worthwhile.
Other factors to consider include validating that the CDMS system is compatible with an electronic health records (EHR) system. You will also want to verify that the system can seamlessly integrate with other platforms, such as your organization’s laboratory information management systems (LIMS).
Go Find It Can Help with CDMS Selection
The use of clinical data management software is essential to the success of any clinical research project. By providing a centralized repository for data, CDMS streamlines the data collection and analysis process, helping ensure the accuracy and consistency of data throughout the project lifecycle.
If you’re not sure where to start in selecting a clinical data management software system that fits your needs, contact our expert team to discuss. We would be glad to help!