Start-up Biotech
Situation: BiotechX has its first molecule. They have run 3 healthy-volunteer Phase 1 trials, and are about to start their first trial in patients. They want to get started quickly, and know that the data-related decisions they make now will affect their whole development program, including their submission.
Implementation: They license in Core DLPs, which define all the core data domains they will need to include.
For example, they don’t have to spend time identifying the AE questions to ask.
The AE DLP tells them how they’ll be expected to present the safety data, how it should be analyzed, and what the database structure should be.
It provides a CRF layout and completion instructions, along with recommended data quality checks.
The Core DLPs eliminate the need for the development team to spend its time reinventing the core data domains and lets it focus its time and expertise on the data specific to its molecule.