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