News

Dilworth, MN – Clinical and bioanalytical studies supporting pharmacology projects and multi-site patient trials continue at AXIS. Various projects supporting research to address the Coronavirus pandemic and other critical research for oncology, neurology, women’s health, and other key therapeutic areas are ongoing.

We have placed critical polices for safety and sanitization protocols for staff and participants. Daily reviews are being undertaken to ensure that our facilities and overall operations continue to be a clean and safe environment for all. We believe these steps will be appropriate and allow healthy volunteer studies with in-house stays to be conducted safely as well as overseeing clinical trials given the current SARS-Cov2 outbreak restrictions.

Dilworth, MN – Axis Clinicals USA announces they have received ERT Certification. The Certification program ensures sites are proficient in collecting the highest quality ECG data. This is done by conducting Phase I QT assessments using ERT’s proprietary Expert Precision QT approach.

With Axis Clinicals being ERT certified, we are able to work with biopharmaceutical clients making recommendations on the design, conduct, analysis, and interpretation of continuous Holter recordings to assess the cardiac safety profile of a drug during various pharmacology studies. AXIS’ encompassing clinical and bioanalytical operations at our purposed built facility in Dilworth, Minnesota allows expedited results with bioanalysis samples walked to an adjacent laboratory to the clinic, ideal for First-In-Human, Single Ascending Dose/Multiple Ascending Dose and Cardiac Safety pharmacology studies conducted at any time of a drug developments’ program.

About AXIS Clinicals USA
Our Dilworth, Minnesota (Fargo, ND area) Clinical/bioanalytical operations is centrally located in the US with a proven history of enrolling large panels of compliant healthy volunteers and targeted patient populations for complex studies.

For more information
John Pottier – Vice President, Business Development
j.pottier@axisclinicals.com

Dilworth, MN- AXIS Clinicals is pleased to announce the hire of Michael S. Willett, PharmD, RAC as the newest Senior Advisor for our clinical and scientific affairs team. Dr. Willett provides senior scientific input into the design and execution of early phase clinical trials. Dr. Willett has over 30 years of experience in clinical research and started his career at Marion Laboratories and Bristol-Myers Squibb where he was involved in all phases of cardiovascular and metabolic clinical research and multiple key product launches. Later he moved to the contract research organization (CRO) side of the industry. In 1994, he founded Advanced Biomedical Research, Inc, a full-service Phase I-IV CRO that focused on innovator compounds and complex studies. In 2009, he established Ready Clinical, LLC as a clinical and regulatory consultancy. Dr. Willett received his Bachelor and Doctor of Pharmacy degrees with honors from the University of Illinois and completed a residency in adult internal medicine at the University of Missouri-Kansas City and Truman Medical Center. For the past decade, he has maintained a US regulatory affairs certification from the Regulatory Affairs Professional Society.

Hyderabad, INDIA – AXIS Clinicals Limited (AXIS), a full-service clinical research organization (CRO), announces the opening of clinical operations in China with a Phase 1 BA/BE facility in Changsha, China in the province of Hunan.

“Our New Phase 1 BA/BE Clinical Facility is established to support best in class research for innovative as well as generic pharmaceutical product development. This expansion compliments AXIS Clinicals continued growth in various geographies and is intended to assist our clients in maximizing their opportunities,” said B. Phani Bhushan Reddy, Executive Director of AXIS Clinicals – Hyderabad.

This new hospital-based facility will assist AXIS Clinicals in meeting expanding client bases within China and globally while expanding into unmet areas of pharmaceutical research needs. This increases worldwide bed capacity as well as providing significant space for future expansion due to a continuing increase in demand for our services.

Highly experienced technical team for AXIS Clinicals was instrumental in establishing the world-class CRO services in China. The plans include a state-of-the-art Bioanalytical facility meeting local and international regulatory requirements.

This new Phase 1 BA/BE Clinical facility complements AXIS Clinicals established clinical and bioanalytical facilities in India, Mexico, and the USA. The current global AXIS Clinicals sites have successfully completed many global regulatory and client audits. “We are excited about our growth opportunities in Changsha, China and have already begun expansion plans.” Added Mr. B. Phani Bhushan Reddy.

About AXIS Clinicals

AXIS Clinicals is a Global Clinical Research Organization with operations in India, China, Mexico, and the United States. AXIS Clinicals is committed to serving the biopharmaceutical industry with Quality Deliveries. The AXIS team is well-experienced in the conduct of Phase I/IIa pharmacology clinical trials including First-In-Man, BA/BE, DDI’s, Bioanalysis, and Clinical End Point Trials (Phase II-IV).

Global AXIS has 14 years of audit success with FDA-USA, MHRA-UK, INFARMED- Portugal, AFSSAPS/ANSM-France, ANVISA- Brazil, WHO, GCC, NPRA-Malaysia, MCC-South Africa, MHSD RoK, Thai GLP, Turkey MOH, NABL, and India CDSCO; and therefore has the Quality Standards to ensure the ‘Best in Class Standards’ for Changsha, China.

For further information, please feel free to contact AXIS Business Development Team at BD@axisclinicals.com or www.axisclinicals.com

Dilworth, MN – AXIS Clinicals is pleased to announce the expansion of our US clinical site with the addition of 45 hospital beds, offering the flexibility of 225 total beds in four clinical units and one outpatient unit. This addition compliments the original Dilworth facility design which was built to accommodate simultaneous studies of differing complexity. The addition of hospital beds highlights the current expansion of AXIS Clinicals in the North American and International marketplace. Likewise, this expansion enhances our capabilities to accommodate the complex project needs of the ever evolving pharmaceutical research industry.

“In addition of hospital beds to our existing phlebotomy recliners provides enhanced subject safety and flexibility while affording comfort in our clinical research facility. This expansion effort supports our ongoing pharmacology studies for NDA, ANDA and 505(b)(2) filings as well as post-market product assessments. AXIS USA continues to support our clinical and bioanalytical operations for Single-Ascending-Dose/Multiple Ascending Dose, FIH, and Drug-Drug-Interaction studies, Cardiac Safety, and Topical Products in addition to expedited projects and reports, and all under a single roof” said Dr. James Carlson (Chief Scientific Officer).”

As a CRO focused in early clinical as well as offering support for bioavailability, bioequivalence and topical product programs, AXIS strategically continues to provide complete solutions for global filings ranging from study designs to integrated final reports.

About AXIS Clinicals USA:
AXIS Clinicals USA, a full-service Contract Research Organization (CRO), is joined by the global sites of AXIS Mexico (Est. 2010), AXIS India (Headquarters & In-House Clinical Studies, Est. 2004) and Axis India (Patient and Clinical Endpoint Studies, Est. 2015). AXIS USA offers the convenience of a purpose-designed 120,000 square foot facility to handle multiple studies simultaneously, including an in-house bioanalytical lab capable of handling over 15,000 samples per month, an on-site Dermatology Center, and a fully licensed, DEA registered Pharmacy. With our global locations, we offer the flexibility and convenience of working with one company across multiple countries.

For more information

John Pottier
Vice President, Business Development
913-314-6755
j.pottier@axisclinicals.com