Medical professionals carry out clinical trials to evaluate if a new drug or medical device is safe and effective. They collect data from the trial participants which they’ll analyze to draw conclusions. If the trial results are favorable, the experimental drug or medical device will be approved for manufacture and made available on the market.
Scientists used to rely on spreadsheets to record data and manage the administrative components of clinical trials. However, this traditional method resulted in a higher incidence of errors and incomplete data collection aside from being time-intensive.
Clinical Trial Automation Software
To streamline this tedious process, the clinical trial industry started using specialized software. One type is the integrated clinical trial automation software. This software is cloud-based and dedicated to specific areas of a clinical trial such as metadata management, case report form (CRF) design, data storage, statistical analysis, compliance with regulatory standards, and generation of reports to be submitted to regulatory bodies.
As a medical researcher, how will you know which software is most suitable for your clinical trials? This article addresses this, so read on.
Here are the features of a compelling clinical trial software:
- Allows Easy Integration
As a research facility, you utilize several tools to run your operations. Most of these operations need data from the trial participants and the clinical trial itself.
Therefore, reliable clinical trial software should be able to integrate with external systems such as electronic data capture (EDC) software that stores data collected from trial participants and a statistical analysis system (SAS) that processes data in various formats. Integration with your internal systems is also essential as it allows convenient transfer of clinical data, allowing you to save a lot of time and avoiding data discrepancy.
- Facilitates CDISC Compliance
Your clinical trial software should ensure your compliance with standards prescribed by the Clinical Data Interchange Standards Consortium (CDISC), Analysis Data Model (ADaM), and the National Cancer Institute (NCI).
The software should also be equipped with validation tools that pinpoint any problems or issues with the clinical study. With this unique feature, you can immediately address potential problems, ensuring the timely submission of reports or findings.
- Allows Versioning
It’s also critical that your software allows versioning or having different versions of the case report form to suit various purposes. As there might be changes in the internal standards and those of the clinical study, the software should be flexible enough to allow you to make the necessary updates.
- Allows Metadata Standardization And Reuse
The ideal clinical trial automation software allows you to standardize and reuse approved clinical metadata. The retrieval of such data from the standardized library should be quick and easy, enabling you to use existing metadata content for succeeding clinical studies. This feature contributes to the consistency and efficiency of clinical trials.
- Manages Changes Easily
As there would be instances when it’s necessary to make changes to metadata stored in the system, the software should permit revisions to metadata content. However, any changes made should be properly documented such as who requested the revision, who made the revision, and when the revision was made.
This feature provides complete traceability, which is essential to the protection of data integrity.
- Provides Impact Analysis
The ideal clinical trial software should have built-in impact analysis. This lets you see the impact of proposed changes on upstream and downstream processes of the clinical study even before you make such changes.
- Gives Data Visibility
Another valuable feature of clinical trial software is real-time data visibility. Being able to view trial data as soon as they’re processed by the EDC allows you to make data-driven decisions on the experimental drug’s safety and efficacy.
- Enables Easy Data Retrieval
The clinical trial software should allow ready retrieval of metadata. Since content is stored in a single repository, finding the metadata you need is quick and easy. Sharing and managing the metadata is likewise convenient using cloud-based software.
- Performs Fast SDTM Conversions
Your software should have the capability to anticipate the structure of your SDTM datasets at the design stage. This gives you a preview of your datasets even before the actual collection of data from trial participants. This enables you to start working on dataset design and mappings. The software will take it from there and perform instant SDTM dataset conversions.
Clinical trial automation software is an innovation that changed how clinical trials are being done today. They’re more efficient, resulting in improved data quality. This article highlighted the features you need to look for when choosing clinical trial software to invest in. Be sure to take them into account in your selection process, and you won’t go wrong with your decision.