Clinical Research Quality & Audit Readiness
Evidence-backed audit workflows, CAPA support, quality intelligence, and inspection-readiness tools for sites, CROs, sponsors, and regulated research teams. Professional starts at $199/month; Enterprise is custom-priced.
Professional — starting at $199/month
Designed for independent consultants, QA professionals, clinical research sites, and smaller study teams seeking evidence-backed audit support without enterprise complexity. Includes internal audit preparation, source-document review support, CAPA workflow support, missing-document detection, evidence-linked findings, confidence indicators, audit-ready reporting, and single-site deployment.
Enterprise — custom pricing
Built for CROs, sponsors, and regulated quality programs requiring portfolio-level oversight, sponsor visibility, vendor oversight support, organization-specific workflows, dedicated onboarding, validation support, custom reporting, and enterprise implementation.
Built around how your organization works
From a single site to a full portfolio, AuditingLab adapts to your role in the study.
Clinical Research Sites
Identify documentation gaps, protocol compliance risks, consent issues, and inspection-readiness concerns before they become findings.
CROs
Improve quality oversight across studies, standardize review processes, reduce manual effort, and strengthen sponsor reporting.
Sponsors
Gain visibility into study quality, vendor performance, documentation risk, and portfolio-wide inspection readiness.
Pricing aligned to study complexity, risk, and scale
Organizations differ significantly in study volume, documentation requirements, quality workflows, and oversight needs. AuditingLab pricing scales according to deployment complexity and organizational requirements.
- Number of studies
- Number of sites
- Number of users
- CRO vs Sponsor vs Site
- Audit volume
- CAPA workflow complexity
- Reporting requirements
- Implementation support
- Validation requirements
See what an evidence-backed finding looks like
Every finding is grounded in your documents, flagged with a confidence indicator, and built for human review — never an automated verdict.
Example finding: Informed consent version may not match the current protocol amendment.
Evidence cited: ICF v2.1 references Protocol v3.0, while the protocol on file is v4.0 (Amendment 2).
- Linked to the exact source pages so your team can verify in seconds.
- A suggested CAPA step is provided — your QA team decides and signs off.
Built for evidence-backed audit workflows
Trust comes from clear evidence and human-reviewable outputs — not badges or guarantees.
- Findings grounded in documentation
- Confidence indicators
- Missing information clearly identified
- Audit trail support
- CAPA workflow support
- Human-reviewable outputs
- Evidence-linked reporting
- Inspection-readiness support
Not sure which plan fits? Book a 30-minute strategy session with our QA team, or schedule a consultation and we will reach out. Read client testimonials to see real outcomes.