DATA MANAGEMENT LAB DATA – Phase I
Phase I studies require collecting a large amount of safety data, and conduct an exhaustive validation in order to ensure data quality. This clinical trial had two different cohorts, the first one consisted in dose escalation. The population was enrolled at one unique site.
- Handling a large volume of lab data.
- Handling a large volume of queries.
- Accomplishing tight timing requirements in order to deliver quickly the final database.
- Conduct lab data transfers instead of entering all data into the eCRF.
- Manage all quereis together (fired by eCRF + programmed using SAS).
- Provide an ad hoc tool to accelerate the resolution of queries.
Data collection and query resolution times wee reduced significantly, compensating the previous logistic delays. The client could proceed to start the CSR as committed to the advisory board.