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.
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.
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.
We bring in experienced biostatisticians, programmers and data managers quickly, focusing first on the workstreams that are holding the study back.
We take over from an existing biometrics provider, reviewing datasets, code and documentation before moving the work into a controlled handover.
Where previous validation is incomplete, we rebuild the evidence, close quality gaps and bring the work back to a standard that can be defended.
We reconstruct missing or inconsistent documentation and restore traceability, so the study record is clear, complete and ready for review.
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.
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.
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.
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.
The people who step into the rescue stay with it, preserving context and continuity through recovery, handover and close-out.
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.
Across sponsor-triggered FDA, EMA, PEI and Swissmedic inspections following rescue work, we have had no critical or major findings.
Evidence beyond the trial, from PASS to external controls.
Explore →Independent data monitoring for studies under review.
Explore →Preclinical statistics and regulatory writing.
Explore →FSP or project-based — flexibility post-rescue.
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