Bioanalytical – AXIS Clinicals

Bioanalytical Services

Delivering Bioanalytical Results for Pharmacokinetic and Pharmacology Studies Rapidly and Reliably

Our state of the art bioanalytical lab is one of the leading labs for small-molecule bioanalysis in the US.

Obtain expedited results for your SAD/MAD studies from our Integrated bioanalytical laboratory and Phase I Clinical Research Unit

Our Sponsors cut weeks from their early-phase programs by utilizing our onsite bioanalytical laboratory. We provide expedited analysis for dose-escalation.

Expert Bioanalytical Services for Early-Phase Pharmacology Studies

Our bioanalytical capabilities are fully integrated to support and advance your studies during early Phase I. Our experts will ensure the analytical method of choice is suitable for your early Phase I needs.

We develop and validate methods, ensuring they conform to all global regulatory requirements. If the method is already developed, we will transfer and re-validate it fully.   Our bioanalytical laboratory is equipped to handle 15,000+ samples per month, ensuring that sample analysis for your studies is performed in a matter of days.

Did you know? We have access to more than 500 validated assays and we can develop and validate an assay within 4 weeks.

Fully Integrated Bioanalytical Services for Late-Stage Phase II-IV Studies

Our late-stage bioanalytical offering seamlessly connects with CROs and clinical sites for Phase II-IV trials. Our bioanalytical team works with CRO project managers and CRAs to ensure on-time availability of PK sample kits at all sites while maintaining appropriate masking.

The process for dispatch, shipping, and collection of samples is closely monitored to ensure temperature control is maintained and documented in coordination with partner courier agencies.

The PK sample results are rapidly provided according to Data Transfer Agreements. A complete bioanalytical report per ICH M10 norms is generated at the end of your study for regulatory submission.

We have successfully delivered end-to-end bioanalytical services for large Phase III studies with sites across the US, Asia, and Europe.

AXIS Clinicals’ bioanalytical laboratory features state-of-the-art research platforms

The Scinote® ELN system and Thermo Scientific Watson® LIMS are used for all data collection, processing, and reporting. This provides a complete audit trail, ensuring compliance with global regulatory guidelines.

Our bioanalytical laboratory was audited by the FDA as recently as 2023 with no 483s.

What the industry is saying about AXIS

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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.

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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.

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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.

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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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