Custom web application case study: The Wistar Institute
The Challenge
Dr. Luis Montaner’s lab, located at The Wistar Institute, is focused on HIV–related research. The lab needed a web–based, clinical trial data–collection tool that both fit their tight budget, while meeting the strict requirements of the U.S. Food and Drug Association (FDA). Off–the–shelf solutions had proven either too cumbersome or cost prohibitive.
The Solution
Given the budgetary constraints, we chose open–source technologies that are freely available: PHP, a programming language used for creating dynamic web applications; and MySQL, a relational database system, capable of storing complex datasets.
We worked in collaboration with the team at the Montaner lab to conduct a systematic requirements analysis, from which we developed a functional specification complete with use cases, wire frames and screen shots.
In parallel, we extensively researched the FDA’s guidelines on electronic records and electronic signatures. We then hired a company that specializes in FDA–regulated technology services to facilitate with the system architecture, in order to ensure that we were building an FDA–compliant system.
We then built the application based on the functional specification and proposed architecture. We validated the system, following standard operating procedures created during this process and, finally, deployed the system in three environments: development (used for ongoing development), staging (where validation of new features is conducted) and production (the live website).
The final product is a web–based tool that is used by sites located around the globe, participating in clinical trials conducted by or facilitated by the Montaner Lab. We continue to work with the lab to both support clinical trials in progress, as well as, create custom forms and features for new trials.