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Where tomorrow is today

First-in-Human trials with clinical oversight and FDA-ready data — faster and with no IND and CTA required. 

With faster ethics approval, no IND or CTA required, and digitized data delivered immediately, we help you gain a critical time advantage without compromising quality. Our physician-led teams provide scientific oversight at every stage. The integrated site and regulatory model keeps your trial moving with speed, clarity, and control.

First in line for First-in-Human

The sooner you start, the sooner you advance. We help you reach first dose faster with fewer delays and greater control.

  • IND-exempt model with no US regulatory delays
  • Ethics approval in as short as 4 to 6 weeks
  • Fast, flexible startup with regulatory and site support combined
  • Digitized operations for rapid, reliable data delivery
  • Proven experience with over 240 First-in-Human studies

Globally positioned. FDA-ready.

Our systems are built to global standards, so you get audit-ready data, total traceability, and confidence your results will stand up anywhere.

  • US-aligned regulatory model with globally harmonized protocols
  • Digitized operations with real-time data
  • GMP-aligned facilities and validated processes
  • Electronic QMS with full audit trails
  • 80+ successful audits, including FDA inspections

Straight to the scientists

You’ll have direct access to the experts running your study, with clinical leadership involved from first conversation to final data delivery.

  • Clinician-led from feasibility through to close-out
  • Direct input into protocol design and startup planning
  • Scientific oversight built into every stage of delivery
  • Trusted by global sponsors across 750+ trials
  • 75% of studies come from repeat business and referrals

Get in touch to find out how soon your study could be up and running

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