Focused engagement
Study Rescue Diagnostic
A rapid, senior review that identifies what is failing, what matters first and what a defensible recovery path looks like.
When to use it
Best fit
Biotech, sponsor or CRO teams with a delayed, blocked or technically uncertain study and an immediate decision to make.
Scope
- Review the protocol, SAP and available specifications.
- Assess dataset, output and issue inventories at the level needed to locate material gaps.
- Examine alignment across analysis decisions, data structures, TLFs and the target milestone.
- Classify risks and define the smallest credible next phase.
Inputs
- Protocol and SAP or current analysis specification.
- Available raw, SDTM or ADaM inventories and specifications.
- Priority TLFs, validation findings and current issue log.
- Target milestone, deadline and known constraints.
Deliverables
- Rescue diagnostic memo.
- Prioritised P1/P2/P3 issue log.
- Open-decision table and remediation plan by workstream.
- Recommended scope for any follow-on QC, reprogramming or readiness work.
Data handling
Real patient or confidential study data remains within the client, sponsor, CRO or contractually approved environment. The permitted data, access model and retention rules are agreed before work begins.
Do not send patient, clinical or confidential study data.
Boundaries
- Does not include full reprogramming, upstream data management, final submission or complete medical writing.
- Does not include hosting real study data in Algoria-owned infrastructure.
- The diagnostic identifies and prioritises risk; it does not guarantee that every issue can be resolved within the initial engagement.
Discuss this engagement
Confirm fit before sharing materials.
Begin with the study situation, intended decision and timing. Data access is agreed only after scope and safeguards are defined.