A biopharmaceutical company focused on developing novel medicines, approached us to help them create a validated form submission framework that could meet their unique business requirements. As the client was undergoing clinical trials prior to FDA approval, it was vital that they implement a centralized portal as part of their Risk Evaluation and Mitigation Strategy (REMS), that would consolidate and triage any adverse events or product complaints.
To this end, they needed an effective system where healthcare professionals could receive feedback from their patients. To be FDA compliant and to mobilize the appropriate response, all of the information would need to be validated, normalized and tracked. Their existing system was resource-heavy, relying on manual processes, which opened them up to numerous opportunities for issues to arise.
In solving this challenge, we knew that the user experience had to be simple. We combined multiple forms into a single responsive, multi-step submission that ensured the data could be captured quickly, easily and in its entirety from any device. By making use of a centralized document collection system, the data was then validated and safely stored in the cloud. A secure online platform allowed for quick and easy access to this information, while offering on-demand, automated, and customized reporting.
Due to the confidential nature of the data, we ensured that security was a top priority. By taking charge of the entire lifecycle of the project including the management of the hosting environment, we were able to ensure that there was no downtime as the new system was deployed.
For our client, getting this system right was vital to their business. Our innovative system provided a tool to guide the process from submission to resolution, eliminating the margin for human error. Our customized solution not only increased efficiency, but also improved accuracy and accessibility, all while adhering to the very highest compliance and security standards.