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AXIS Clinicals USA offers the gold standard in expertise and timeliness when it comes to BA/BE studies.  With over 200 years of collective upper management experience, we offer quick turnaround, flexible scheduling, and on-site bioanalysis for immediate sample analysis. Whether you need Fed, Fast, or Sprinkle, a Pilot, Pivotal, or a Fast-to-File, our team of experts can seamlessly support you from protocol development to final report.

To date, AXIS Clinicals USA has dosed capsules, tablets, patches, sublingual films and tablets, injectable suspensions, and gummy products, with the knowledge and experience to dose many additional drug forms across all therapeutic areas and routes of administration.

Our clinical staff has experience in running clinical trials for both generic and innovator pharmaceutical clients, including multiple study designs, dosage forms, and a wide variety of sponsor requirements. The clinical unit is fully integrated with a  licensed pharmacy capable of handling Schedule II-V controlled substances with temperature and humidity controls.

The in-house bioanalytical laboratory offers method development, assay validation, and sample analysis in compliance with FDA and international regulatory requirements and constant check from in-process quality control and quality assurance teams. We perform Incurred Sample Reanalysis (ISR) in strict compliance with the protocol and regulatory requirements.

Our recruiting team has a history of efficient enrollment in multiple subject populations, including healthy males and females, older adults, smokers, and menopausal women.

The AXIS appeal features a very friendly staff, great food, and reclining phlebotomy chairs for both comfort and safety. 

BA/BE

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Phase 1

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Our Phase I facility is a one-stop shop for all your clinical trial needs:

  • Drug-Drug Interaction (DDI)
  • Food Effects
  • Single Ascending Dose (SAD)
  • Multiple Ascending Dose (MAD)

Our AXIS Clinicals USA team has extensive experience in all forms of dermatology products and studies. Our clinic is well equipped to handle overnight dermatology studies and outpatient visits. The 6,000 square-foot, walk-in Dermatology Center can handle numerous outpatient visits per day.

We have the ability to conduct a wide spectrum of studies for dermatology products, including

  • Topical products (patch, gel, cream, lotion, ointment, foam, liquid, etc.)
  • Vasoconstrictor assay (VCA) for topical corticosteroids
  • Transdermal patches
  • Dermal PK (safety and efficacy studies)
  • Dermal adhesion (FDA standard and dot adhesion models)
  • Primary and cumulative dermal irritation and sensitivity studies
  • Human Repeat Insult Patch Test (HRIPT) Studies

Our dermatology team includes industry leaders in vasoconstrictor studies, with

  • Extensive experience of dose duration response, bioequivalence, and relative potency for many corticosteroid products.
  • Outstanding recruiting rates for all our vasoconstrictor
  • Validated CR400 Konica Minolta Chroma Meters.

Our in-house medical writing and statistics teams work with industry experts and are well versed on the latest FDA requirements for dermatology data analysis and reporting. Our team provides a complete end-to-end service for all forms of topical pharmaceuticals.

Dermatology

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