Focused engagement
Submission Readiness Pre-Audit
An independent, risk-based review of whether study evidence is coherent, traceable and ready for its next formal gate.
When to use it
Best fit
Sponsors and CROs preparing for CSR completion, internal audit, due diligence, vendor transfer or a regulatory submission milestone.
Scope
- Review dataset inventory and SDTM/ADaM consistency.
- Assess SAP-to-output alignment and end-to-end traceability.
- Review available metadata, define.xml, reviewer guides and validation findings.
- Classify material findings and establish a remediation sequence.
Inputs
- Protocol, SAP and analysis specifications.
- Versioned SDTM/ADaM datasets and relevant source inventories.
- TLF package, define.xml and reviewer guides where available.
- Validation reports and prior review comments.
Deliverables
- Submission-readiness pre-audit report.
- Findings classified by severity and likely impact.
- Traceability and metadata findings.
- Remediation roadmap and executive summary.
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 guarantee regulatory acceptance or inspection success.
- Does not include eCTD publishing, formal agency interaction or complete reprogramming unless separately scoped.
- Does not make Algoria a critical GxP system or host for real study data.
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.