Executive summary
A research pack for life sciences clinical operations teams that turns every number behind the feasibility investment case into a sourced, graded, challengeable assumption.
What is inside
What the pack covers
The asset covers the assumption classes a trial operations investment case depends on, how observed performance is kept separate from hypotheses about improvement, how research effort is prioritized and capped, and how the finished register is challenged and frozen before the options appraisal begins. It includes a worked synthetic example and a failure case.
- Why trial operations investment cases stall at review: enrollment and startup numbers nobody can trace
- Five assumption classes the investment case needs: demand, unit cost, benefit, alternatives, and uncertainty
- Where this pack sits: after the baseline diagnostic and readiness assessment, before the options appraisal
- Separating observed site and enrollment performance from recruitment hypotheses
- Directing research effort only at the assumptions that move the case
- A challenge and freeze gate that produces an auditable version 1.0
- A worked synthetic sponsor example, a failure case, and a community practice activity