Early-Stage Phase I – AXIS Clinicals

Early-Stage Phase I Services

Leveraging our experience with a scientifically grounded approach to progress your pharmacology studies

AXIS will be your clinical research partner for all your early-stage pharmacology enabling studies throughout your development program.

Our studies support NDA, 505(b)(2), Vaccines, and Biologics License Application (BLA) regulatory filings

We have experience conducting clinical studies of new chemical entities from a new biological entity, novel formulations, and complex generics.

We are accomplished at all early-stage studies required for drug development

Our onsite bioanalytical laboratory provides expedited analysis for dose-escalation studies

Our clinical units and bioanalytical laboratory are in the same building which elimates the need for shipping the samples.

We conduct our studies at our state-of-the-art Clinical Pharmacology Units (CPUs) in Minnesota

Over 40 studies a year are successfully conducted at the CPUs, with participant size ranging from 10 to 300+

120,000 sq ft facility
consisting of multiple flexible study units

234 participant
capacity

54
Hospital beds

Onsite
clinical safety lab

We have more than 130 staff with industry experience, various degree levels Masters, PhD, PharmD, and MD degrees

Our team has experience with a wide array of drug-delivery methods

Our pharmacists will aid you in the development of a robust drug preparation, compounding, and dosing protocol and provide training to ensure consistent dosing.

What the industry is saying about AXIS

"
Partnering with AXIS has been a transformative experience for us. Their team deeply understands the complexities of pharmacology cardiac safety TQT projects and has been exceptionally responsive and proactive at every stage. What could have been a challenging process was made significantly smoother, with seamless coordination between clinical and bioanalysis under one roof, keeping timelines on track and delivering high-quality data.

"
AXIS has been our long-time reliable partner for clinical research. Their team understands the challenges of developing 505(b)(2) products and has provided solid support throughout our clinical development program of studies. They’ve helped us stay on track and navigate a complex process with professionalism and quality data. I would recommend them to all of my industry contacts looking for a dependable CRO partner.

"
AXIS has consistently delivered outstanding support as a Phase 1 site partner. Their ability to recruit and enroll subjects quickly and efficiently has been a key factor in keeping our timelines on track. The team is professional, responsive, and well-organized, ensuring the smooth execution of even the most complex pharmacology studies. We value their expertise and look forward to continued collaboration.

"
We've worked with AXIS Clinicals USA on several Phase 1 studies, and their ability to quickly enroll subjects has been a huge advantage for us. They’re efficient, easy to work with, and always meet our timelines. Their team handles everything smoothly, which makes our job easier. We’re grateful for their support and look forward to working with them again.

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