What is a Clinical Trial Rescue?
A clinical trial rescue is a targeted intervention that fixes an at-risk study’s statistics: its sample size and power calculations, its endpoint or estimand, its Statistical Analysis Plan, its interim analyses, or its CDISC-compliant datasets.
Clinical Trial Rescue Services
The Purpose of Our Clinical Trial Rescue Service
EvoClinical’s clinical trial rescue service is for one specific situation: a study already underway that’s run into a statistical or data problem serious enough to put its results at risk.
We step in, find exactly what’s wrong, and fix it, so you get a trial that holds up under regulatory review instead of one headed for a costly re-run.
Clinical Trial Rescue Services
90% of clinical trials fail to reach approval
That number covers every kind of trial failure, not just the preventable kind. But a real share of it traces back to the trial’s statistics, not its science, and most rescue conversations in this industry never look there. They start with sites and enrollment.
Signs Your Trial Needs a Statistical Rescue
A handful of warning signs point to a problem rooted in your trial’s statistics rather than its operations. If any of these sound familiar, it’s worth a second look before the study goes further off track.
Sample size or power calculation
A sample size or power calculation that stopped holding up once the trial began enrolling
Endpoint or estimand
An endpoint or estimand that regulators pushed back on, or that doesn't match what the data is actually showing
Interim analysis
An interim analysis that came back unclear, or a DSMB recommendation nobody is sure how to act on
Letter from Regulatory Bodies
A statistical deficiency letter from FDA, Health Canada or EMA
Statistical Analysis Plan
A Statistical Analysis Plan that reads like a template rather than a plan built for this specific trial
CDISC compliant
Data that isn't CDISC compliant, which is holding up database lock or submission
Tables, listings, and figures
Tables, listings, and figures that keep coming back late, wrong, or inconsistent with the protocol
CRO Continuity
A statistics team at your current CRO that turned over mid-study, taking the trial's institutional knowledge with them
EvoClinical's Clinical Trial Rescue Process
01
Rapid statistical audit
We review the Statistical Analysis Plan, the sample size assumptions, the endpoint definitions, and the current state of your data against the protocol and what regulators expect.
02
Root-cause diagnosis
We pinpoint exactly where the design or analysis went wrong, and what it’s costing the study in time, credibility, or both.
03
Remediation plan
A plan scoped to your trial specifically: re-power the study, rewrite the SAP, realign the endpoint, rebuild the datasets, or prepare the regulatory response, whichever combination applies to what we found.
04
Execution
Our senior statisticians carry out the plan directly. We can work alongside your existing CRO or take the engagement on as a standalone project, depending on what your trial needs.
Clinical Trial Rescue Services
Common Statistical Rescue Engagements
Here’s what a statistical rescue engagement typically covers. Most projects involve two or three of these, not all ten.
- Statistical Analysis Plan audit and rewrite
- Sample size and power re-estimation
- Endpoint and estimand realignment
- Interim analysis and DSMB support
- CDISC SDTM/ADaM remediation
- Database lock recovery
- Regulatory response support for statistical deficiency letters
- TLF (tables, listings, figures) programming rescue
- Data quality triage and cleaning
- Adaptive design correction
Clinical Trial Rescue Services
Why Clients Choose EvoClinical For Clinical Trial Rescue
Senior Expertise
You get senior statisticians from day one. No one on your project is learning your trial for the first time while the clock is running.
Credentials
Half of our statisticians hold PhDs, and our team carries credentials with the American Statistical Association, the Statistical Society of Canada, CDISC, SAS, and PSTAT.
Therapeutic Areas
We've worked across oncology, rare disease, CNS, and other therapeutic areas, so the fix fits your trial instead of a generic template.
Flexible CRO Partner
We can work alongside your current CRO instead of replacing them, if that's the better path for your study.
Talk to Our Clinical Rescue Team
A trial that’s already slipping doesn’t get better with time. Talk to a senior statistician about what’s happening in yours, and what it would take to fix it.
FAQ - Clinical Trial Rescue
What is a clinical trial rescue?
A clinical trial rescue is when a sponsor brings in a new team to fix a study that’s in trouble, whether that’s a missed enrollment target, a data problem, or a flaw in the trial’s design or analysis. EvoClinical’s rescue work focuses specifically on the statistics: the sample size, the endpoint, the analysis plan, and the data itself.
How is a statistical rescue different from a full CRO rescue?
A full CRO rescue usually replaces the entire team running your trial, including sites, monitoring, and project management. A statistical rescue is narrower. EvoClinical’s statisticians fix the design, endpoint, or data problem specifically, often while your existing CRO keeps running everything else.
Can EvoClinical work alongside our current CRO instead of replacing them?
Yes. Rescue engagements typically run alongside a sponsor’s existing CRO. We take on the statistical work directly and coordinate with your current team rather than requiring a full switch.
How fast can a statistical rescue start?
That depends on how quickly we can get access to your trial data and documentation. Once we have it, the initial audit is usually the fastest part of the process. Reach out and we’ll tell you what a realistic timeline looks like for your specific situation.
What causes a trial to need a statistical rescue?
The most common causes are a sample size or power calculation that didn’t hold up once the trial got underway, an endpoint that regulators pushed back on, an interim analysis that came back unclear, or a Statistical Analysis Plan that wasn’t built for the trial it’s supposed to serve.
Can you help after we've received an FDA, Health Canada or EMA statistical deficiency letter?
Yes. Responding to a statistical deficiency letter is one of the more common reasons sponsors bring us in. We review what the agency flagged, build a response grounded in the actual data, and work with you on next steps.