Delivering Quality, Timely Solutions In Early Phase Clinical Research

Auckland Clinical Studies (ACS) provides state-of-the-art world class research facilities and the expertise to perform Phase I and II studies for the pharmaceutical and biotechnology industry.

About ACS

Professor Ed Gane

MB ChB, MD, FRACP, MNZM Professor Gane has a vast research experience. He is first author of more than 50-refereed publications. He has been Principal Investigator for many important and ground-breaking hepatitis studies conducted at ACS.

Want to get involved as a volunteer?

Participant Info

About Clinical Trials Learn More

Our Facilities

See our modern new facilities See More

Current Clinical Trials

View our list of current studies and clinical trials Learn More

Completed Trials


ACS first became involved in developing a novel oral compound for the treatment of hepatitis C under the Sponsorship of US biotech, Pharmasset, a company subsequently acquired by Gilead Sciences Inc. Since that date, ACS has been integrally involved in the Phase 2 development of the compound (now known as sofosbuvir) under the study name Electron. Ground-breaking results of this study were recently published in the New England Journal of Medicine (N Engl J Med 2013;368:34-44).


ACS was asked to conduct a Phase I Absorption, Distribution, Metabolism & Excretion (ADME) study of a C14-labelled oncology agent. Working with an oncologist from University of Auckland and the Department of Nuclear Medicine at Auckland City Hospital, ACS dosed 8 subjects with a single infusion of the IMP. The subjects were inpatient for approximately 8 days until >85% of radiation was recovered. Continuous urine and fecal collections were made for liquid scintillation counting and blood samples collected for PK analysis.


This Phase 1 study evaluated the pharmacokinetics and safety of a biosimilar in healthy volunteers. The challenge was to recruit, randomise and dose 200 subjects in a 3-month timeframe. In collaboration with sister-company CCST, regulatory and Ethics Committee approval was gained in two weeks for both sites under one application. Screening to last subject dosed was achieved in the 3-month timeframe.


This entry-in-human study evaluated the safety and efficacy of single ascending doses of a topical IMP as a wound healing agent in 43 healthy volunteers. Working with an infectious diseases physician and a dermatologist, a series of punch biopsies were made and IMP dosed. The wounds were assessed histologically, photographically and visually at follow-up visits. This was a challenging study and successfully completed within agreed timelines.

Why Auckland New Zealand?

  • Auckland is New Zealand’s largest city and has a patient/volunteer regional catchment population of around 2 million.
  • ACS is situated directly opposite Auckland’s leading tertiary referral hospital, Auckland City Hospital (ACH) and has access to a full range of medical specialities and LabPLUS, ACH’s premier medical laboratory.
  • Auckland is fortunate in having many clinical research groups in most therapeutic disciplines associated with the Auckland School of Medicine and Auckland’s major tertiary hospitals. These researchers are fully supportive and keen to participate in joint ventures and recruit patients for Phase I and II studies.
  • ACS is within walking distance of New Zealand’s major university, the University of Auckland; many of the students are willing to participate in healthy volunteer studies. ACS now has more than 4,000 names on its volunteer data-base.
  • The favourable New Zealand economic environment and supportive Regulatory system enables us to offer timely and quality services at a competitive price.

News & Events

ACS stand out among IQVIA preferred clinical trial sites

Auckland Clinical Studies has been recognized for superior performance and quality in clinical research in 2017.  After being selected by IQVIA In November 2016 as their first preferred partner clinical trial site globally,


Professor Ed Gane’s outstanding contributions to the development of a simple and potent cure for chronic Hepatitis C were recently recognized when he was named the 2017 New Zealand Innovator of the year


ACS joins Christchurch Clinical Studies Trust as the first two ECD QuintilesIMS Prime Sites


The symposium on 12th October 2017 at the Marion Davis Libraray at ACH was to celebrate the last 10yrs

University of Hong Kong-Shenzhen Hospital delegation visiting ACS

“ACS has an enviable global reputation not only based on their contribution to finding very effective new treatments for chronic hepatitis C, but also as a result of innovative studies in many other therapeutic indications including oncology rare diseases” – Associate Prof Wai-Kay Seto


28 April 2017 – Auckland Clinical Studies (ACS) proudly celebrated 10 years as an early phase clinical pharmacology unit in Auckland, New Zealand.