270+ Protocols audited

100% Compliance

0% Delay Rate

$20M+ Funding secured

The Challenge

Operating under strict federal mandates, a single compliance breach could trigger an immediate funding freeze across the institution. Teams often viewed governance review as a bureaucratic hurdle and sometimes under-reported risk to avoid delays — creating hidden liability.

The Solution

Built a proactive, upstream advisory model instead of a reactive gate — coaching technical leads on risk mitigation before formal submission, reframing governance as a partner rather than a bottleneck. Co-designed workflow solutions that preserved teams' original project designs while embedding regulatory safeguards.

The Impact

• 100% regulatory compliance sustained across 270+ protocols over a multi-year period.

• Zero funding disruptions — no project lost funding or missed a critical window due to internal review delays.

• Culture shift — moved technical teams from risk-avoidant reporting to proactive, compliance-first collaboration.

• Improved Research Design — Anticipating ethical and regulatory constraints increased participant satisfaction, and investigator effectiveness