By: Dr. Leigh J. Mack | Chief Medical Officer
Clinical Studio is one of the simplest clinical trial software systems to use for a trial. It takes only a couple days to learn the system and has the robustness to run a multi-site, multi-national Phase III trial with ease. The user interface is very approachable and straightforward to use. A CRF can be created in 30 minutes and a trial can be created in days. No coding is needed and the system has randomization, ePRO, and a plethora of options for form design to capture the data needed in a very exacting format.
Imagine copy and pasting from a protocol to create a CRF and trail SOPs; it is really that simple. Another concern is data input accuracy; this can be addressed simply by employing the ePRO part of Clinical Studio. Our ePRO allows the trial designer to easily create a direct data capture from a wearable device, direct participant survey or response to a compliance question; that then automatically posts the data to the participant’s file within the trial. The source data no longer resides on a paper form but actually as a data set collected in a secure, FDA 21 CFR Part 11 compliant server. The Clinical Studio server data is stored on multiple systems in multiple locations, so loss of any data is never a concern.
Clinical Studio is a very flexible system that allows any user to feel comfortable within days of learning. The system was designed to grow with your company and be able to interface with many other software systems, EMRs, as well as healthcare wearables in an FDA compliant environment. Clinical Studio easily allows the system administrator to assign levels of access as well as accounts for the monitor to observe the trial in near real-time. Because the system is cloud based, no data resides on any device and is always secure, so the CRO can feel confident and providing superior service to the sponsor at all times. In addition, the software is designed to grow with the CRO to provide up-to-date technologies and the latest in digital security.