When a trial needs a
clear recovery plan

When timelines slip or the data no longer tells a clear story, we step in quickly to find the issue, reset the priorities and get the study moving again.

Trial in trouble?
We help stabilise the study and find a clear way forward.

Rapid triage

We assess the data, deliverables, vendors and timeline within one to two weeks, giving you a clear view of what is working, what is at risk and what needs attention first.

Rapid team mobilisation

We bring in experienced biostatisticians, programmers and data managers quickly, focusing first on the workstreams that are holding the study back.

Biometrics provider takeover

We take over from an existing biometrics provider, reviewing datasets, code and documentation before moving the work into a controlled handover.

Re-validation & QC

Where previous validation is incomplete, we rebuild the evidence, close quality gaps and bring the work back to a standard that can be defended.

Documentation rebuild

We reconstruct missing or inconsistent documentation and restore traceability, so the study record is clear, complete and ready for review.

Delivery or FSP handover

We stay with the study through database lock or submission, or prepare a structured handover into an FSP model when longer-term support is needed.

When a trial goes off track, we know where to start

Whether the issue is a mismatch between the SAP and SDTM, repeated team changes or a quality concern close to submission, we step in quickly to understand what is happening. From there, we identify the critical issues, set clear priorities and put a practical recovery plan in place to get the study back under control.

  • We bring a structured rescue approach to studies already under pressure.
  • Senior specialists assess the programme quickly, even when we were not part of the original team.
  • We establish what is working, what is not, and what needs attention first.
  • We build a recovery plan that carries the study through to database lock, submission or a stable handover.
Metronomia colleagues in a corridor huddle

The right judgement, from day one

Rescue starts with understanding the problem quickly and clearly. We begin with senior-led triage, bring in the right expertise early, and turn what we find into a practical recovery plan that gives the study a clear way forward.

Rapid support

Senior biostatisticians and project managers can join an initial assessment within 24 hours, with on-site support available within a week when the situation requires it.

95% staff retention

The people who step into the rescue stay with it, preserving context and continuity through recovery, handover and close-out.

36 years of experience

Our teams are used to stepping into programmes they did not start, quickly understanding what is there and rebuilding the work to a clear, defensible standard.

Zero critical findings

Across sponsor-triggered FDA, EMA, PEI and Swissmedic inspections following rescue work, we have had no critical or major findings.