
Case Brief
Scenario
One of the biggest challenges for clinical researchers is generating intuitive and usable patient profiles in a timely manner using real-time data. Several systems will extract data and generate outputs/graphs but not as a comprehensive document for medical monitors to review (ie., SpotFire). Medical monitors benefit from being able to see all data entered into EDC on a particular patient at any given time. The ability to generate profiles against several EDC systems is important; the ability to integrate from several systems (IRT, labs) is equally important.
Strategy
- Work with client to identify depth and breadth of need (data fields, timing, etc.)
- Review EDC system and EDC format
- Generate dry run output (only with fields, formatting and flow)
- Option a) provide client with the algorithm to generate the profiles on their own
- Option b) provide client with patient profiles according to their schedule or ad hoc
Outcome
To further enhance clinical trial efficiency, explore how we simplify literature searches for DSUR in our related post