A global pharmaceutical company clinical trials department was putting in a lot of manual effort in monitoring significant quality events (SQEs’). These are the events that may occur during the trial which impact the study or push the timelines of the entire trial. The subject matter experts (SMEs’) had to manually access the database and study the entire clinical trials records to identify details of an SQE event. The raw information was lengthy which made the whole process tedious and time-consuming.
The SMEs were also not able to get any insights to understand the reason, trends and patterns from the historical SQE data. The client approached i2e to reduce the manual effort in monitoring SQEs and design an analytics system for the SQE data. They even wanted an algorithm to identify protocols at risk.
Our team understood the client’s requirements and divided the project into three phases, solving one problem in each phase.