AXIS Clinicals USA - Full-Service CRO - A Mighty Year in Review

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Looking Back on 2015: Successful FDA and Sponsor Audits, the Launch of Patient Trials, Joining the Verified Clinical Trails Network, Completed Studies, Company Growth, and Receiving the Star Business Award.

“At AXIS, we have a commitment to excellence and quality, day in and day out.”

AXIS Clinicals USA, although new to the area, has made great headway shortly after opening doors in November 2014 at their 120,000 square foot facility just outside of the Fargo, ND area.

AXIS Clinicals USA, a full-service Contract Research Organization (CRO), is joined by other global sites - AXIS Mexico (Est 2010) and AXIS India (Headquarters, Est 2004). AXIS USA offers the conveniences of its purpose-built facility to handle multiple studies at once, including an in-house Bioanalytical lab capable of handling over 15,000 samples per month, an on-site Dermatology Center, and a fully licensed Pharmacy. Moreover, it offers the additional benefits of employee technical expertise, flexibility, and the convenience of working with one company across multiple countries.

Having a location in the Fargo, ND - Moorhead, MN area has many benefits, including a high concentration of universities with access to tens of thousands of student volunteers, a community familiar with clinical studies, and a vast pool of trained professionals with years of experience in the clinical research field.

In 2015, AXIS Clinicals USA conducted 26 studies, paid out over $1,000,000 in study volunteer stipends and referrals, and dosed over 850 volunteers. AXIS currently has 80 employees, including 40 full-time employees, and was awarded the Star Business of the Year Award from The City of Dilworth in recognition of what it has done for the city and community.

Along with the many studies conducted in 2015 came many sponsor audits, as well as a very successful FDA audit following two of the pivotal studies completed at AXIS Clinicals USA. Dinkar Sindhu, CEO of AXIS Clinicals USA, stated, "We were very pleased with the outcome of the audit, and how our day to day attention to quality clearly displays our overall commitment to excellence.”

While AXIS USA has primarily focused on Phase I, Bioavailability/Bioequivalence, and Dermatology trials in its initial years of business, 2015 marked the launch of the AXIS USA Patient Trials Division, Phase II - IV. As the other global AXIS locations have been conducting successful patient trials for years, AXIS is bringing the same capabilities to the USA. In 2015, Patricia Henderson, Director of Clinical Operations (Patient Trials), joined the team to lead the way.

Patricia brings over 24 years of experience to AXIS Clinicals and has been recognized by four of the top Big Pharma companies for her outstanding work in running research sites. She has created a growing network of more than 250 physicians for patient trials across the United States. Patricia commented, “Building a new division goes beyond the department – it’s creating a culture in employees who are passionate about the cause. It’s being a part of a community that can cure diseases and make a difference that can impact future generations to come. In patient trials, we take that to heart.”

AXIS sets the bar high when it comes to volunteer safety. In June 2015, AXIS took a step further in safety precautions and became the first in the region to initiate the use of the Verified Clinical Trials (VCT) system. VCT addresses the issue of duplicate enrollment in clinical trials across different CRO sites by identifying those volunteers currently enrolled in other clinical studies or dosed in a study within the last 30 days. This system protects the health of each volunteer and also improves the quality of the data that is collected for the study, thus benefitting the volunteer and the sponsor.

John Peterson, Senior Director, Clinical Operations, led the implementation of VCT and currently serves as Principal Investigator and Pharmacist at AXIS. Dr. Peterson stated, “We are acutely aware of the issues surrounding the professional research subject. While we know volunteers will travel great distances to enroll in more than one trial too soon, having three units in close proximity in the region only increases the chances of duplicate enrollment and protocol violations. We care about our volunteers and our sponsors, and joining VCT was an easy decision to make.”

With 2015 behind them, AXIS is looking for another great year in 2016 as the company aims to double the number of studies conducted and employ over 100 personnel. AXIS is dedicated to becoming one of the top CROs in North America in the years to come.

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Darby Miller, Project Manager

Sidharth Mishra, Vice President, Business Development & Project Management
since: 01/2014
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