CASE SNAPSHOT 03

Phase II/III Rescue / CNS Multi-Country

Trial rescue is not cosmetic project management. It is the restoration of signal integrity, feasibility realism, and execution control before the dataset loses decision value.

CONTEXT

The situation

A late-phase CNS program was at risk due to feasibility drift, unstable enrollment, delayed activation, and vendor underperformance.

DECISION CHALLENGE

What had to be resolved

Over-optimistic feasibility assumptions
Misaligned country and site mix
Startup and recruitment cadence failing against plan
RBQM and escalation logic not tuned to endpoint and data-quality risk

OUR INTERVENTION

What changed in the decision system

Re-forecasted feasibility using operational reality rather than legacy assumptions
Rebuilt country/site strategy and activation cadence
Reset vendor oversight, delivery metrics, and escalation rules
Aligned RBQM with endpoint risk, recruitment variance, and database-lock interpretability

OUTCOMES

What the programme gained

Enrollment stabilized
Forecast accuracy improved through rolling forecasts and activation cadence
Measurement and data-quality controls restored interpretability at database lock
Governance became more predictable and decision-oriented

STRATEGIC IMPLICATION

A rescue plan must protect the future evidence package, not only accelerate recruitment.

RELATED CAPABILITY

Trial Rescue & Execution Governance

Restore feasibility realism, decision rights, vendor control and evidence integrity before delay becomes loss of programme value.

A SIMILAR DECISION?

Use the evidence before the next irreversible commitment.

Bring the live decision, the next hard milestone and the uncertainty that is currently exposed.