Developing new therapeutics is a time and resource-intensive task. Depending on the disease and therapy, clinical trials can take six years or more. This process can be significantly streamlined and shortened.
The goal of clinical trial managers and clinical operations teams is to complete clinical trials in a timely manner while following stringent and specific guidelines. Running a successful trial demands knowledge, focus, energy, and grit as each error is costly and delays drug approval.
Cutting-edge software solutions, such as Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS), the benchmarks of modern clinical trial management, are built to expedite this process. Separately they address clinical trial management and data acquisition but, when unified, they are capable of much more.
A clinical EDC system is a software database system that allows researchers to collect, monitor, deposit, and report on data collected at clinical sites. Real-time data availability and reduced query management time make this technology the most desirable option which is critical for late-phase trials. On the other hand, an efficient CTMS supports trial setup, organization, operations, as well successful clinical trial completion. These systems are used for site management and monitoring, patient recruitment, financial and contact management, and sometimes regulatory document tracking.
When they replaced standard paper-based knowledge assortment methodology, the use of both EDC and CTMS systems decreased the time to completion of clinical trials by an astounding 30%. However, our expertise has shown us that in healthcare, separated options often carry a risk of errors due to difficulties created by the creation of separate data silos and their subsequent reconciliation.
For these reasons, we at niAnalytics have created a unified solution that tends to the most important of clinical trial needs. We firmly believe that errorless data assessment leads to quicker approval of new high-quality therapies and efficient disease management. In times of need, by reducing approval-time, we save lives.
Our unique approach offers EDC/CTMS, with data management and biostatistics from study inception all the way to the final Clinical Study Report. Depending on its complexity we can set up a trial in our system in as little as 24h, thus drastically reducing expenses and time to market.
Real-time available, distributed, immediately accessible, and accurate information is a necessity for agile clinical trial management. This is exactly what our system and workflows provide. It controls different study sites, allows running multiple trials within a single organization/instance at once, provides simultaneous multi-language support, and much more. Additionally, patient and site data can be easily extracted at any time without the requirement of a data lock.
At niAnalytics, we provide solutions that are beyond electronic data capture. In fact, our system is more than just clinical trial software, and niAnalytics GmbH is not only a clinical data management organization, we are a full data management solution adaptable to any organization and large scale monitoring.