Eligibility supportability
Verification of inclusion and exclusion criteria against source documentation.
Physician-led clinical assurance
Targeted review of patient recordssupporting eligibility and safety decisions in clinical trials.
Clinical trial data begins in the patient record.
We review the source record, the clinical context, and the decision as it was made.
Safety traceability
Review of AE and SAE documentation across source, eCRF, and safety systems.
Inspection-facing defensibility
Assessment of whether selected records are coherent and suitable for regulatory scrutiny.
When sponsors call us
High-risk sites and RBQM signals
Follow-up review of elevated deviation rates, safety-reporting anomalies, or other signals requiring source-level clarification.
Difficult eligibility or safety cases
Assessment of cases where eligibility decisions, safety conclusions, or clinical interpretation are not straightforward and require physician-level judgment.
Before inspection
Focused review of whether selected records are complete, coherent, and suitable for regulatory scrutiny.
Early-phase review and due diligence
Assessment of limited datasets where subject-level inconsistencies may affect development, governance, or transaction decisions.
Peer-to-Peer Clinical Perspective
Core principle
Physician-led review enables direct peer-to-peer engagement with investigators and site physicians.
Where it matters
In complex cases, eligibility decisions, safety interpretation, and protocol-relevant clinical judgments cannot be resolved through documentation review or QA assessment alone.
Clinical context
Assessment focuses on how clinical information was interpreted at the time the decision was made.
Value
Enables clinically grounded, professionally credible evaluation of whether decisions were reasonable—supporting defensibility of participant safety and data integrity.
Why physician-led review matters
Some trial questions cannot be resolved through process review alone.
Because our reviewers are physicians, we assess records from both a clinical and inspection-facing perspective.
Where appropriate, we can engage investigators in peer-to-peer discussion to clarify how the clinical facts were understood at the time and whether the record and resulting decision remain supportable.
We assess whether the decision was reasonable at the time it was made, based on the information available at that time.
Reviews are conducted on-site at the investigational site, or within a sponsor-approved secure review environment.