TRIAL RESCUE & EXECUTION GOVERNANCE

Restore control before the dataset loses decision value

A structured recovery mandate for trials that are slow, unstable, misaligned or no longer protecting the development thesis.

The problem

Activity is increasing while confidence is falling

Enrollment plans drift, sites behave differently from feasibility assumptions, vendor reports do not clarify decisions and quality signals surface too late. Recovery requires diagnosis of the system, not more pressure on isolated metrics.

What we do

Diagnose the failure mode and reset the system

Recruitment, eligibility and patient-flow diagnosis
Country, site and vendor performance reset
Protocol-burden and screen-failure analysis
Rater strategy, calibration and variability control
Risk-based quality management and signal review
Governance, escalation and decision-right redesign
Recovery plan tied to interpretability at database lock

Best fit

Use this mandate when delay is no longer the only risk

Enrollment is materially behind plan or screen failure is rising.
Countries, sites or vendors are underperforming without a clear cause.
Protocol amendments are being discussed without a system diagnosis.
Quality, rater or data variability threaten signal integrity.
Governance produces reports but not timely decisions.

WHAT CHANGES AFTER THE ENGAGEMENT

From unexplained drift to governed recovery

BEFORE

The programme was losing control

Recruitment, country and site performance, vendor behaviour and quality signals were drifting without one diagnosis of the underlying system.

INTERVENTION

Reset the operating architecture

Feasibility, country and site mix, activation cadence, vendor oversight, RBQM, escalation and sponsor decision rights were reconnected to the intended readout.

WHAT CHANGED

Variance became actionable

The sponsor regained a controlled recruitment and governance cadence with earlier visibility of site, vendor and quality deviations.

VALUE PROTECTED

The readout remained the objective

Recovery was governed around signal integrity and interpretability rather than activity volume or calendar pressure alone.

See the anonymised case snapshots →

Reconnect recovery to the development thesis

A decision-grade next step

Recover the trial without sacrificing the readout.

The recovery plan must protect decision value, not only the calendar.