Site auditing
Independent Auditing for GLP-Aligned Preclinical Studies
Effective site auditing is a core risk control mechanism in preclinical development.
Many organisations engage auditors too late, after discrepancies emerge. At that point, corrective actions become costly and timelines are shift.
PROMAFUN CRIO provides independent site study auditing to confirm that studies are performed according to agreed standards and protocols, with a focus on Good Laboratory Practice (GLP) compliance and decision relevance.
We do not inspect as a checklist exercise. We audit to verify robustness, traceability, and defensibility of study execution and documentation.
Why
Study Auditing Matters
Audit findings can affect:
• Regulatory acceptance
• Credibility of data packages
• Investor confidence
• Internal governance reviews
• Project timelines
When audits are reactive rather than proactive, organisations risk:
• Incomplete documentatioon
• Protocol deviations
• Data integrity issues
• Regulatory pushback
• Delayed reporting
Outcome:
Lost time, cost overruns, and weakened strategic position.
Site study auditing mitigates these risks before they become barriers.
Our Independent Audit Role
PROMAFUN CRIO serves as an external, unbiased auditor between your organisation, CRO partners, and regulatory frameworks.
We evaluate study execution against:
• Protocol requirements
• GLP standards
• Quality assurance expectations
• Funder reporting norms
• Documentation completeness
Our objective:
Verify that study conduct and documentation are defensible in external evaluations, audits, and regulatory scrutiny.
Core Auditing Services
Protocol Review and Pre-Audit Assessment
We review:
• Protocol design
• Methodology alignment
• Endpoint definitions
• Quality assurance mechanisms
Outcome:
Early identification of gaps before study execution.
On-site Execution Evaluation
We audit :
• Test site infrastructure and equipment
• Conduct of study procedures
• Sample handling and traceability
• Adherence to GLP norm
Outcome: Confidence that execution matches documented plans.
Documentation and Record Review
We assess:
• Raw data and audit trails
• Chain of custody
• Deviations and corrective actions
• QA and QC reports
• Final study records
Outcome: You can demostrate data integrity to external reviewers.
Compliance Insight and Reporting
We provide independent audit reports that:
• Identify risks and non-conformances
• Suggest corrective actions
• Place findings in regulatory context
• Support reporting to funders or agencies
Outcome: Clear documentation for governance and external stakeholders.
Decision-Centric Auditing
We audit with the expectation that:
Study records must be defensible in regulatory reviews, funding evaluations, and partner due diligence
This means:
• We interpret findings in context
• We frame issues in terms of decision impact
• We recommend actions that lower strategic risk
Outcome: Your audit outcomes support, rather than jeopardise, regulatory and funding pathways.
Who Engages Site Study Auditing
Organisations that benefit most include:
• Companies commissioning external preclinical studies
• Project coordinators responsible for study portfolios
• Research teams preparing regulatory submissions
• Organisations seeking investor confidence
• SMEs without internal QA/audit capacity
• Consortia managing multi-site studies
These teams engage us when independent verification of study conduct and documentation is important for decisions and compliance.
Start with an Audit Readiness Assessment
If you are planning or conducting preclinical toxicology, pharmacology, or efficacy studies and want to confirm whether you site and documentation are audit-ready, we recommend starting with an audit readiness review.
This helps identify:
• Documentation gaps
• Protocol conflicts
• GLP deviations
• Traceability issues
• Risk points requiring mitigation
Why This Approach Works
PROMAFUN CRIO audits are:
• Independent – no execution bias
• Context-aware – aligned with regulatory expectations
• Decision-focused – oriented toward defensible outcomes
• Standardized – consistent with GLP and documentation norms
• Clear – audit reports supported with actionable insights
This prevents post-hoc surprises and supports confident external reporting
Contact Form
Ensure your study meets the highest standards.
Tell us about your study, sites, and audit needs. Our team will get back to you within 48 hours.