Clinical trial management software is a tool that helps manage clinical trials. It can be used for planning, organizing and managing clinical trials and is often used in conjunction with the electronic data capture software. Clinical trial management software can be used by researchers to organize their workflows, keep track of tasks or even help them stay on budget during the project’s development phase.
Software Features Required
A good clinical trial management software should have a user interface that is intuitive and easy to use. It should also be able to import data from other systems, such as patient management systems or CRFs. It should also be able to export data in various formats like Excel and PDF. According to Medable’s experts, “The software should integrate with other systems, such as traditional databases and electronic health records (EHR).”
The final requirement is the ability of the software to generate reports on the progress of your clinical trials at regular intervals.
Implementation
Though the software has been developed and tested, it is not ready for use until it is implemented into your business processes. A good CRM provider will do this for you, but it is important to ask them how they will do so. You need to know if they are going to provide training on how to use the software, as well as ensure that your staff is trained on how best to utilize the system. In some cases, there may be a need for customization or configuration of certain features before implementation begins.
User Adoption and Training
User adoption and training are very important to the success of a clinical trial. If users do not understand the software or if they are not provided with adequate training on how to use it, it may lead to problems during study execution. For example, if users do not know how to use an e-signature feature in your clinical trial management system, you may end up having some data missing from your results because patients were unable to sign consent documents electronically. A good way for you as an administrator to measure user adoption is by looking at user documentation and training materials.
Monitoring Activities
Monitoring activities are concerned with monitoring the progress of the clinical trial. This can be done at different levels, including:
- Monitoring of the trial progress: This includes identifying each phase and stage of a clinical trial, keeping track of resources involved in monitoring, such as time and money, identifying any changes that may affect the plan, etc.
- Monitoring of trial status: This involves identifying any issues that might arise during a clinical trial, such as problems with patient recruitment or randomization issues, etc., which may result in delays.
- Monitoring budget utilization: It is important to monitor how much money has been spent compared with how much money has been allocated for each phase or stage so that budget overruns can be avoided.
Trial Reporting
Reporting is a critical part of the trial management process, as it helps you to understand the progress of your trial and make decisions about its future. The reports generated by your clinical software are typically broken down into two types:
- Historical reports – These usually look at data from previous trials to provide an overview of how things have changed over time.
- Real-time reports – These reflect current performance by providing information on how many patients have been recruited and unblinded so far and whether they’ve stayed in line with their recruitment targets.
We hope this article helped you understand how to use clinical trial managemet software in order to experience a seamless process.
