About Us

We are a physician-led audit and consulting practice built on more than 20 years of experience in clinical research and GCP auditing.

Our team combines medical expertise with deep quality assurance background. Our experts are physicians and auditors — a rare combination developed through more than 20 years of work across clinical operations, medical monitoring, pharmacovigilance, and regulatory inspections.

That combination matters because it allows clinical data to be assessed from both sides: as medical evidence and as inspection-facing audit material. We understand how data is generated, interpreted, challenged, and defended.

This matters because clinical trial data originates at the patient level. Every eligibility decision, every safety event, and every data point reflects a clinical reality — not just documentation.

We focus on that level.

What physician review adds

Our audits are performed by physicians who assess not only compliance with GCP requirements, but also the clinical validity and internal consistency of the data. This includes:

Inclusion/Exclusion verification based on source records

AE/SAE identification, medical interpretation, and reconciliation

Subject-level data integrity and clinical plausibility

Inspection readiness aligned with ICH GCP E6(R3)

We do not replace standard GCP audits.

We strengthen them where medical judgment matters.

  • Patient-level evidence
  • Medical plausibility
  • Inspection-facing clarity