Clinical research is complex. Study designs are increasingly more complex as clinical research teams build databases that must support adaptive designs. Combine this innovative science with wearable technologies and new treatments, and you can see the degree of complexity exploding across the clinical trial lifecycle. Even regulatory agencies are taking note. In response to this trend, the FDA is conducting a CID (Complex Innovative Design) pilot meeting program to facilitate and advance the use of complex adaptive, Bayesian, and other novel clinical trial designs.
This growing complexity is also creating a market of sophisticated clinical trial technology buyers. They understand the scientific process and requirements. They may not understand the underlying technology, but their expectations are high. Clinical trial teams have integrated technology into every aspect of their lives. Smartphones, wearables and even travel booking websites have evolved to support a tech-enabled, 21st-century society that takes much of the underlying technology for granted.
For example, travel sites allow users to input their travel dates when planning a trip. Modern sites let the user know if the start date entered is after the end date. This type of real-time data validation is now assumed. The user experience is simple, quick and relatively painless. As we all become more adept at using these tools in our personal lives, we carry the expectations and assumptions into our work lives. We assume our research tools have made similar progress, particularly in the area of study building.
Study build is typically a very labor and time-intensive task. Traditionally, clinical trial database builds required costly programming expertise. However, intelligent study build tools can now bring powerful functionality to that process. Building tables and defining variables no longer require a database administrator. Data collection tools such as case report forms can be designed and built using common drag-and-drop functionality that leverages technology to complete a broader array of activities in a shorter timeframe.
These same tools provide continued flexibility to respond to mid-study changes and eventually to export the data from the system. Traditional rigid platforms required teams to work harder or create time-intensive workarounds, to address a protocol change. So many factors contribute to a protocol amendment (human, medical, compliance). Intelligent build tools remove the complexity by utilizing industry knowledge that is built into drop-down menus and automated processes that simplify tasks. These intelligent tools look familiar and help research teams apply their expertise without having to translate it into a programming language or utilize costly resources to make changes.
Intelligent build tools enable clinical trial teams to apply technology in complex clinical trials in the same way they apply technology to other aspects of their lives. Technology partners must align their development plans with these emerging needs and expectations. The rapid escalation in technology awareness in the 21st century demands simple and flexible solutions that support complex science. The pressure to innovate is mounting. Intuitive interfaces, great user experiences, and non-industry technology expectations are all motivating technology partners to stay ahead of these emerging requirements.
The Mednet team makes delivering intelligent study build tools a priority within our solution, iMednet. Our product strategy is based on the working principle that the study build process poses the greatest opportunity for efficiency gains. Intelligent build tools combine automation with industry knowledge to simplify the complexities of building and managing clinical trials. To learn more about iMednet or schedule a demonstration, contact us today.