CRO Services – AXIS Clinicals

Phase II to IV

Let’s take your product from concept to approval

AXIS is uniquely positioned to provide cost and time-efficient solutions for
any of your clinical development needs at phases II to IV.

We have established in-depth expertise in Clinical Pharmacology and Early stage development

We have experience conducting Pharmacology studies for NCE, NBE, Biosimilars, 505(b)(2) and repurposed NCEs
Our qualified and experienced staff and board-certified dermatologists allow us to execute studies for Topicals and Transdermal products.
We have proven experience of conducting all type of Clin Pharm studies such as SAD/MAD, DDI, Dose proportionality, FE, hADME, TQT.
We are the only CRO licensed to perform dOFM studies in the US

We have established in-depth therapeutic area expertise.

Oncology

We have conducted multiple studies across the US in hematological cancers as well as solid tumors.

Dermatology

We combine our highly qualified staff with a proven network of dermatology investigators to give your study the exceptional attention it deserves.

Respiratory

Our team will help in rapid start-up and selection of high-enrollment sites.

Explore our comprehensive CRO services

We handle everything from the big picture to the smallest detail

We offer stand-alone services for your project as well.

Reducing complexity with meticulous planning and real time communication

Our approach

We understand that each project is unique. We start with a structured kickoff meeting to ensure that every project is carefully planned for timely communication and seamless workflow. We strive for quality and precision in study conduct to facilitate regulatory approval.

Our project managers and CRAs maintain real-time communication with the sites to monitor enrollment and study conduct. Our preferred vendor partners help us ensure seamless study execution.

The team’s highest priority is to achieve stakeholder satisfaction
through project engagement to successfully execute the study.

Ensuring quality and consistency in data with robust planning and regular monitoring

Clinical trial success starts early with a robust study design. Our data managers develop effective and comprehensive CRFs to ensure quality and consistent data are collected during the study.

The CRAs perform real-time monitoring to resolve inconsistencies early and perform onsite source document verification to ensure accuracy of the data.

Success Through Transparent and Real-Time Communication

Communication is key

Clear communication at all times is the bedrock of a successful trial. Our project manager and CRAs maintain a close watch on enrollment, study conduct, and vendor supplies. Any potential issues are identified early and brought to the Sponsor’s attention for appropriate resolution.

With our always-on team availability, we have the flexibility needed to respond quickly to any challenge and develop mitigation strategies to reduce risk to project execution.

The team’s highest priority is to achieve stakeholder satisfaction
through project engagement to successfully execute the study.

Comprehensive clinical monitoring by experienced staff

Our start-up monitoring includes Protocol Training, Therapeutic Training, Pre-study Site Visits, Investigator Meeting/Site Initiation Visit, Staff Training, Site Communication, and Enrollment Strategy
Our enrollment and maintenance processes involve Site Management Calls, Remote Review, Query Resolution, Protocol Compliance, Training, Enrollment Gaps, Identifying Trends, Issue Escalation, Safety Review, and Essential Document Collection
Our close-out procedure includes Database Lock Activities, Query Resolution, Closing of Action Items, Close-Out Visit, and Final Essential Document Collection

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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