Every engagement is scoped to the trial, the sponsor, and the specific risk in front of you — not a fixed package.
Site, vendor, and CRO audits assessing compliance with ICH E6(R3) and applicable regulations.
Preparing sites and sponsors for regulatory inspections, with mock inspections and gap remediation.
Risk-based quality management strategy and implementation aligned with ICH E6(R3).
TMF review, protocol and informed consent quality checks.
Structured comparison of current practices against regulatory requirements, identifying risks before they surface in an audit or inspection.
Ongoing QMS development and review, and broader quality oversight support for sponsors, biotechs, and CROs.
Every audit is grounded in physician-level knowledge of how drugs act in the body, how safety signals emerge, and how benefit and risk are weighed in practice. This means going beyond procedural checklists to assess whether trial conduct actually protected the people enrolled in it. Audit findings are interpreted through a physician's understanding of drug mechanism, safety signal detection, and benefit-risk evaluation, extending assessment beyond procedural compliance to the clinical adequacy of participant protection.
Tell us the scope, timeline, and location, and we'll come back with a personalized proposal within 24 hours.
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