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The body of medical knowledge mainly grows from the clinical studies carried out with the help of human volunteers, also known as participants. For one, such studies aim to compare the safety and efficacy of proposed treatment plans to those already in existence.
During clinical trials, different medical interventions, such as drugs, devices, and procedures, are administered to participants while strictly adhering to the investigation team’s protocol or research plan. More often than not, the complex process of developing a clinical study’s protocol, also called clinical study build, can be demanding in terms of time and financial resources. This is where clinical trial software can be beneficial.
What Is Clinical Trial Software
Clinical trial software can help you navigate the complexities of clinical studies by enabling you to create your study’s build and design into a management system. The management system can also provide a centralized database that allows your team to consolidate all information, including protocols and participants’ data, in one place.
By automating most of the procedures in clinical studies, clinical trial software can help reduce the time it takes to build studies, availing time for other essential activities. Various innovative technologies can help you take life-saving interventions to the market within a short time, including Formedix clinical trial software.
Considering how modern tools can help you with your clinical studies, in this article, we’ll outline some pointers to keep in mind to help you choose the best clinical trial software.
1. Ensure Compliance With CDISC Standards
The Clinical Data Interchange Standards Consortium (CDISC) governs how medical research and clinical trials are conducted to ensure clinical data integrity, the accuracy of research findings, and patient data protection. They define parameters that must be observed during data collection, analysis, and sharing, to which any clinical trial must adhere. Therefore, ensuring your clinical trial software is compliant with CDISC guarantees compliance with regulatory standards.
2. Assess Integration With Other Software
Ideally, the clinical trial management software you should invest in can seamlessly integrate with other existing third-party applications in your business to streamline the workflow and make data more accessible to the team.
For instance, it should have plug-ins that facilitate integration with leading Electronic Data Capture (EDC) systems. This can pave the way for better collection and processing of patients and various research data essential to your clinical study. Some software also taps into artificial intelligence (AI) to anonymize data submissions.
3. Align With Your Study’s Needs
The type of clinical studies your organization mostly carries out and their criteria can all be instrumental in helping you determine the most suitable software specifications for your needs. For instance, the ideal software for short-term studies where few participants are involved may be inappropriate for extensive clinical trials conducted over a longer term and involving hundreds or thousands of participants.
The more clarity you have concerning your most essential requirements almost guarantees that you’ll invest in the right clinical trial software.
4. Check Data Protection And Security Features
In general, too much sensitive data is collected from participants during clinical trials. That said, data safety must always be a key consideration. The best clinical trial software must offer superior data protection against potential breaches that hackers or network viruses may cause. Furthermore, the software should also be stable and reliable.
On that note, the clinical trial software you should invest in must have advanced security features and backup to protect critical and sensitive data about your clinical study and safeguard patient information. It’d be worth noting, too, that patient data leakages often lead to hefty penalties from authorities and reputational damage that takes a long time to undo.
5. Look At The Collaboration Features
Sharing relevant and critical information in real time is vital for a successful clinical study. It’d be worth noting, too, clinical trials often entail different teams working concurrently, although from various locations. And as such, the right software can make it easy for the team members to effectively communicate and engage virtually. Results from virtual clinical trial companies can lead to timely and more informed decisions that can help improve the integrity of results.
6. Assess Ease Of Use
The ideal management software should simplify your day-to-day activities by automating most manual tasks. It should help eliminate human errors during manual processes, which can significantly compromise your clinical trial. The software should also provide sufficient automation functions that help improve data integrity and reliability.
In addition, clinical trial software should be functional enough and easy to use by all team members with access to it. It should help your teams efficiently run tasks, despite most clinical trials exhibiting a sensitive and complicated nature. And since growth or diversification is a standard expectation in any venture, the software should be scalable enough. You don’t want to go back shopping for software in the future should your operations and research expand.
While data improves medical knowledge, its integrity and accuracy are critical aspects of any clinical trial. Management software can allow you to fast-track your studies if you’re managing an organization involved in clinical trials. It can also help standardize your studies effortlessly, improving data quality and enabling accurate decision-making.
However, the success of your clinical studies can only be assured by your software’s efficiency and reliability. As such, it matters where you source your clinical trial software.