Our facility in Dilworth, Minnesota was built to accommodate multiple simultaneous studies. Our expert professional staff has over 75 years of collective experience in clinical research and a proven track record. In addition, our
- State-of-the art facility has three clinical suites with a total of 180 beds.
- Bioanalytical center, equipped with LC-MS/MS with HPLC and UHPLC systems, Hamilton Nimbus, and Watson LIMS, is capable of handling more than 15,000 samples per month.
- Dedicated Dermatology Center can accommodate multiple outpatient visits per hour for irritation/sensitization scoring or any adhesion evaluation.
- Close proximity to three large universities gives us access to over 20,000 students throughout the year.
- In-house pharmacy has the following:
- Minnesota State Board of Pharmacy licensing
- DEA licensing (Schedule II-V)
- Temperature and humidity control
- Long-term storage
- Secure access (limited)
The AXIS Clinicals USA clinical team has over 75 years of collective 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. In addition, AXIS Clinicals USA has
A thorough training program for all staff members.
Licensed physicians, pharmacists, nurses, and paramedics.
Extensive advertising efforts and access to more than 20,000 students from three large universities.
A vast pool of active, healthy volunteers and successful recruitment for large studies in record time.
Our EDC systems ClinsparkTM allows us to capture and review data in real time, ensuring a complete audit trail and compliance with CDISC standards.
Our 120,000 square-foot facility includes the following:
Three clinical study units
Total capacity of 180 beds (60 per unit)
Comfortable, hospital-grade phlebotomy chairs
Separate 6,000 square-foot unit for outpatient dermatology studies
Sample processing lab with refrigerated centrifuges
Licensed pharmacy with temperature and humidity control
Volunteer screening center with medical history, ECG, and physical exam rooms plus sample collection stations
Volunteer recruiting call center
The AXIS Clinicals USA bioanalytical team is highly experienced and has an extensive understanding of the specific regulatory requirements of the FDA and other international regulatory agencies, as well as constant oversight from an in-process quality control and an independent quality assurance team. In addition, Incurred Sample Reanalysis (ISR) is performed in strict compliance with protocols and regulatory requirements. Our significant expertise in stringent bioanalytical methodologies promises precise and timely analysis with accurate, high-quality results.
We provide end-to-end bioanalytical services, including custom method development, assay validation, and sample analysis in a variety of biological species and matrices.
The experienced bioanalytical team is competent in conducting all types of bioanalysis, including
Pre-and-post-column derivatization procedures
Chiral separation of optical isomers
Conjugate and non-conjugate drug level estimations
Our bioanalytical unit is a 10,000 square-foot lab adjacent to our 180-bed clinical unit in the same building. Notably, it is
Perfectly designed for a single flow, seamless transfer of samples from the clinical freezers into the bioanalytical freezer area.
Equipped with LC-MS/MS with HPLC and UHPLC systems and Hamilton Nimbus workstations for automated sample preparation. Samples are securely stored in -20°C and -80°C freezers that are constantly monitored by Smart-Vue™ Wireless Monitoring system.
Protected by an uninterrupted power supply (UPS) and backup generator system.
AXIS Clinicals USA uses Analyst 1.6.2 software for data acquisition and data processing, along with Thermo Scientific Watson LIMS for study design and data and sample management. A full chain of custody reports for sample tracking, data review, data transmission between sites, reporting, and document management system results in a reduced timeline for report submission.
Chief Executive Officer
Mr. Dinkar brings a rich experience of over 20 years in building and developing organizations. With that, he has developed business and organizational design plans, and has executed these in all phases of organizational maturity. Dinkar has held many leadership positions in the CRO, Pharmaceutical, Engineering, and Railroad industries. He has led teams in International Commercial Operations, Business Development, and General Management. Dinkar holds a Masters Degree in Business Administration and a Bachelors Degree in Engineering.
Chief Scientific Officer
Dr. James “Jim” Carlson, Pharm. D provides over 30 years of experience in the clinical research industry. Dr. Carlson co-founded the PRACS Institute, LTD in Fargo in 1983 and assumed ownership and principal investigator status in 1990. He participated in the expansion at PRACS which included adding e-DC, scientific affairs, regulatory affairs, bioanalytical sample analysis, data management, business development and dermatology studies. Dr. Carlson also served as President/CEO of Algorithme Pharma USA LLC in Fargo. Dr. Carlson received his Bachelors and Doctor of Pharmacy degrees from the Universities of Iowa and Michigan, respectively, as well as a Clinical Pharmacy Residency from Buffalo General, NY. At AXIS Clinicals, Dr. Carlson aids in enhancing our clinical and bioanalytical services to support various studies while facilitating study designs and project execution of these programs.
Vice President, Bioanalytical Operations
With over 25 years of experience in the Bioanalytical field, Mr. Khadang provides overall direction of the Bioanalytical Division, offering hands on leadership in the areas of method development, analytical method validation, and sample analysis. Mr. Khadang has held numerous leadership positions at major CROs at the global capacity by leading teams in the bioanalytical techniques including mass spectrometry, chromatography, and automation. Over the last two decades, he has developed and/or overseen hundreds of LC/MS-MS methods and authored several publications. Mr. Khadang received his B.S. in Analytical Chemistry from Concordia University in Montreal, Quebec. He is a member of the American Society for Mass Spectrometry and the American Association of Pharmaceutical Scientists.
Senior Director, Clinical Operations
Mr. John D. Peterson, Pharm.D., R.Ph., C.C.R.C., has over 20 years in the clinical research industry. He has held management positions with PRACS Institute, Ltd., and Cetero Research. Prior to coming to AXIS Clinicals, Peterson worked as an independent consultant for Lachman Consultant Services and CSM, Inc.
Currently as Sr. Director of Clinical Operations, Peterson oversees clinical study logistics, protocol writing, marketing and recruitment of volunteers, along with pharmacy operations. Historically, has been a Principal Investigator on 60+ projects, and Sub-Investigator on 2,200+ projects.
Peterson is a registered pharmacist in both Minnesota and North Dakota. He received his Doctor of Pharmacy degree from North Dakota State University, Fargo, ND. He is also a member of the Minnesota Pharmaceutical Association, North Dakota Pharmaceutical Association and the Association of Clinical Research Professionals.
Vice President, business development
As a collaborative business development executive, John Pottier has over 25 years of leadership experience within the contact research industry. Identifying and implementing sales and marketing strategies, John has built business models to serve the pharmaceutical markets’ research and development requirements of bioequivalence, 505(b)(2), and pharmacology programs. Facilitating business development initiatives,John addressed clinical research markets within areas of dermatology, cardiac safety, diabetes, and neurology/psychology for ANDA and NDA regulatory filings. John earned a Bachelor of Science Business degree with a major in Marketing and is a member of American Association of Pharmaceutical Scientist, Drug Information Association, and Associates for Affordable Medicines.
Senior Manager, Quality Assurance
Amy Karels brings with her a rich experience of 16 years in clinical research with 11 of those years as a Senior Clinical Coordinator. As a Senior Clinical Coordinator, she worked on a multitude of clinical projects and gained in-depth working perspective on clinical studies. Amy was also involved in many sponsor visits and responded to questions raised during these visits. In addition, she has worked with many disciplines to assure timelines were met and a quality product delivered. For the past year, Amy has been with the Quality Assurance Department with AXIS Clinicals.