Executive summary

A readiness diagnostic for clinical operations teams who must decide where to invest so a trial can open sites and enroll on plan. It scores the operating system around a study on anchored scales and turns gaps into a prioritized, costed investment choice.

What is inside

The 13 sections

Inside are a seven-dimension rubric with scoring anchors and evidence rules, and a two-assessor calibration procedure. Enrollment and schedule formulas link readiness gaps to the three outcome measures. A business case approach keeps capacity separate from cash. Execution, governance and measurement tables are built for activation. A synthetic worked case, a failure case and an alternate scenario show the method in use, and copy-ready tools include a scoring sheet, gap register, feasibility worksheet and calibration log.

  • Purpose and decision
  • Context and applicability
  • Inputs and evidence
  • Definitions and assumptions
  • Method and analytical logic
  • Current-state assessment
  • Options and business case
  • Recommended design
  • Execution and activation
  • Governance and risk
  • Measurement and benefits
  • Worked example and practice
  • Working tools and references