The pathway from clinical trial setup to its successful completion requires resource intensive decision making on a daily basis. Trial planning, finance management, assigning key roles and responsibilities require knowledge, ingenuity, and grit. As we all know, this is a time-intensive and error-prone task. Furthermore, in a large multi-center trial, these decisions get even more complicated. In this case, true leaders rely on expertise more than anything else.
The singular decision that simplifies the process is choosing the right project team and accompanying technology stack. We at niAnalytics, pride ourselves for being the ultimate facilitators of proper decision making.
Usually, clinical investigators first develop a study plan and then adopt the technology for it. Clinical trial planning takes at least six months and implies processing crucial figures. At this stage, our integrated EDC/CTMS doesn’t just add numbers – it makes them flow.
We argue that one of the first decisions should be made upon the choice of a single, integrated technological solution.
The robust functionality of the system facilitates any clinical trial, regardless of its size, at the same time ensuring process continuity from the study preparation to final statistical analysis. It aids in the creation of clinical trial protocol by tending to the objectives, study design, methodology, and trial organization while adhering to GCP and GDMP standards.
The trial setup usually takes months. Our system attends for the statistical analysis plan and allows remote collaboration on the same platform. By integrating more intelligent feedback, the system spreads decision-making between different experts in real-time. While our system comes out of the box with an EDC and read-only document management option, we can create an eTMF solution for multiple simultaneous studies.
After the setup of a trial, we create the eCRF and, if necessary (and recommended) and eMVR. With easy in-trial modifications, it guarantees punctuality and error-free trial flow, thus easing the decision making process.
Our system makes it easy to assign roles to investigators, independent researchers, and other medical staff, at the same time monitoring their every step in real-time. In other words, it is possible to follow information as it is stored. Remote monitoring assures for diligence and guarantees the effectiveness of the study.
Moreover, the system operates on any browser, is simple, intuitive, and user-friendly, so team training is no longer financially or time-exhausting. And the best thing is that its multi-language support makes it easier to manage multinational trials.
Adverse effects are one of the main reasons poor decisions are made, both at the study inception and during operations. Our system can provide real-time notifications for (serious) adverse events and their particulars, thereby facilitating both the initial decisions and trial outcomes. What’s more, data verification is no longer an issue, for the filled database is susceptible to quarries of any type, with query metrics available, and all metadata accessible at any time.
The beauty of it all is that by integrating all processes into one managing platform, the leader’s decisions are driven by the most cost-effective and adaptable technology available.
The bottom line is that when it comes to clinical trials, choosing an all-in-one technological solution is not a thing of taste or a topic for discussion. It is a present reality, and in the end, it’s the best decision.