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  • GLOBAL LOCATIONS

Axis Clinicals

Contract Research Organization

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    • Complex Pharmacology and 505(b)(2)
    • Bioavailability/
      Bioequivalence
    • Topical Delivery – Dermatology
    • Patient Multi-site and Confinement Clinical Trial Management
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  • Participants
    • Upcoming Studies
    • FAQs
  • About Us
    • Clinical
    • Bioanalytical
    • Our Team
  • Services
    • Complex Pharmacology and 505(b)(2)
    • Bioavailability/
      Bioequivalence
    • Topical Delivery – Dermatology
    • Patient Multi-site and Confinement Clinical Trial Management
  • Careers
  • News
  • Sponsor Contact

About Us

Our pharmacology facility in Dilworth, Minnesota was built to accommodate multiple studies simultaneously

AXIS’ scientific and operational management has significant industry experience conducting clinical pharmacology and bioanalytical research projects for a variety of global regulatory NDA, ANDA, 505(b)(2) submissions. Their expertise is proven by our excellent Sponsor and federal regulatory audit track record and results in high rate of returning clients.

  • State-of-the-art facility has four clinical study units that are flexible to suit various study designs
  • Over 228 beds including 48 are hospital beds for both confinement and ambulatory studies
  • Project management to simplify client communication
  • Onsite Clinical laboratory provides prompt results with off-site reference lab back-up
  • Bioanalytical laboratory is equipped with AB-Sciex LC-MS-MS with HPLC and UHPLC systems and supported by the Watson® LIMS and Hamilton Nimbus systems
  • Semi-automated bioanalytical laboratory is capable of handling over 15,000 samples monthly
  • Flex Dermatology Center can accommodate multiple outpatient visits per hour for irritation/sensitivity studies as well as ambulatory adhesion studies
  • Topical products clinical staff can accommodate transdermal PK and vasoconstrictor data collection
  • Adaptable study units can support ambulatory or short onsite visits for Human Factor Studies
  • Close proximity of several universities and college systems provides access to over 30,000 healthy students
  • In-house pharmacy has:
    • Minnesota State Board of Pharmacy Licensure
    • Drug Enforcement Administration (DEA) Certification for Schedule 2-5
    • Temperature and humidity tracking with alarm support systems
    • Routine equipment maintenance and qualification
    • Short and Long-term retention drug sample storage
    • Detailed security system supported by limited, licensed staff access

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Participants

  • Upcoming Studies
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About

  • Clinical
  • Bioanalytical
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Services

  • Complex Pharmacology for NDA, ANDA, and 505(b)(2) filings
  • Bioavailability/Bioequivalence
  • Topical Delivery Products (Dermatology) Transdermal, Creams, Lotions, Ointments, Foam
  • Patient Populations available for Confinement and Multi-site Clinical Trial Management Phase IIa-III

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  •  218-284-AXIS

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