Our Expertise

Our skilled, experienced team of research professionals will work with you to ensure timely delivery of projects with participant safety and quality of data at the forefront.

Our areas of expertise are:

Early in human Phase 1 – IV studies in healthy participants and patient populations.

These trials include:
Small and large molecule, Biosimilar, Food effect, Proof of concept, Drug interactions, Umbrella and complex protocols,
Medical device trials
Protocol review / consultation
Feasibility and research project management support
We produce research in a wide range of therapeutic areas
- Renal Impairment
- Hepatic Impairment
- Oncology
- Special Populations – Ethnic bridging
NZCR has onsite laboratory and pharmacy services and partnerships with local advanced laboratory and imaging service providers
We can also provide Laboratory and Pharmacy manual consultation
NCZR is conducting world leading research in Hepatology and Gene editing.
We have established collaborations in all therapeutic areas (Read more link to our collaborators).

Quality is at the forefront of all our operations

Q Pulse is an electronic quality document management system used to support our quality processes and assist our compliance with regulatory compliance.
Both our units are fully GCP Compliant
FDA audited 2017 – no 483 form or findings
FDA remote record review June 2021 – no observations

Recruitment is key to project success

Dedicated recruitment teams
Large, active healthy participant and patient population databases
Our dedicated recruitment teams produce exceptionally high recruitment rates over a wide range of healthy and patient populations and therapeutic areas.

Our experienced research team ensures enviable trial retention and visit completion rates with our large biosimilar studies having retention and visit completion rates of 98%+

NZCR conducts clinical trials over a wide range of therapeutic areas

Examples of our specific areas of expertise are:

Nephrology Trials

40+ Nephrology trials undertaken across both locations
Experienced Nephrology PI team led by Dr Nick Cross, Professor Richard Robson.
Renal trials undertaken in both healthy and patient populations

Hepatology Trials

147+ Hepatology trials undertaken across both locations
PI World leading Hepatologist Professor Edward Gane
Major role in the development of a cure for Hepatitis C
Leading contributor to Hepatitis C cure and global efforts towards a Hepatitis B cure

Oncology Trials

25+ oncology trials undertaken across both NZCR locations
Experienced Oncologist PI teams
Dedicated oncology trial unit at NZCR- CHC
Strong collaboration with local oncology specialty groups across New Zealand

Biosimilar Trials

35 biosimilar trials completed with 3500+ participants dosed
Proven recruitment track record
Consistent high retention and compliance rates of 98%+

Examples

Over 2017, 2018, ACS and CCST together completed one of the largest global biosimilar trials. 696 healthy volunteers were dosed at two sites, over two time periods. This trial was recruited on time with a < 2% early termination rate. 98%+ of trial visits were completed.
In another large biosimilar study with a cross-over design, 160 healthy volunteers were dosed. The sponsors were delighted with our 100% retention and visit completion rates.
As a rescue site, 114 healthy volunteers were vaccinated and given antibiotic cover according to a complex trial protocol. This trial had a retention rate of 100% and only 0.8% of trial visits were missed

NZCR Key research indications and Specialist Collaborations

NZCR has well established collaborations with local medical specialists

This supports our research in the following key indications.

Key Indication	NZCR Principal Investigators	NZCR Principal Collaborators
Nephrology	Professor Richard Robson Dr Nick Cross
Hepatology	Professor Ed Gane	Dr Ashok Raj Dr Tim King Dr Helen Evans (Paediatrics) Dr Jeffrey Ngu
Oncology	Dr Chris Wynne Dr Tony Rahman	Dr Catherine Han Dr Jennifer McLaughlan
Endocrinology	Professor Russell Scott Dr Jane Kerr	Dr Martin de Bock Dr Ole Schmiedel
Immunology		Professor Rod Dunbar Dr Hilary Longhurst
Cardiovascular		Dr Iain Melton Dr Patrick Gladding
Neurology	Dr Deborah Mason	Dr Justin Kao Dr Gina O’Grady (Paediatrics)
Respiratory		Dr Mark O‘Carroll Dr Mike Epton
Infectious Diseases		Dr Tony Walls
Ophthalmology		Dr Narme Deva Dr Oliver Comyn
Paediatrics	Dr Kerry Orlowski
Obstetrics	Dr Jo Gullam
Gene Editing / Silencing	Professor Ed Gane Dr Hiliary Longhurst

NZCR Research Highlights and Publications

NZCR is at the forefront of early phase clinical research. Our focus on quality and innovation has resulted in many exciting medical breakthroughs. This has included development of break-through therapies for many previously untreatable diseases, including hepatitis, cystic fibrosis, paroxysmal nocturnal haemoglobinuria, alpha-1-antitrypsin deficiency and neuromuscular diseases.

NZCR Research highlights

As ACS and CCST and with our partnering medical specialists, we are at the forefront of clinical research. Examples of our research highlights are as follows:

Major role in the development of a cure for chronic Hepatitis C.
Leading contributor to global efforts for a chronic Hepatitis B cure
Conducted one of the largest global biosimilar studies involving 696 subjects
Completed the initial dose-finding trial which led to Herceptin Sub cutaneous delivery
First in world to develop umbrella protocols
First global in vivo Gene editing trials (SiRNA, mRNA delivery, CRISPR/CAS9)

Examples of NZCR research publications are below:

Lawitz C; Landis CS; Flamm SL; Bonacini M; Ortiz-Lasanta G; Huang J; Zhang J; Kirby BJ; De-Oertel S; Hyland RH; Osinusi AO; Brainard DM; Robson RA; Maliakkal BJ; Gordon SC; Gane EJ. Sofosbuvir plus ribavirin and sofosbuvir plus ledipasvir in patients with genotype 1 or 3 hepatitis C virus and severe renal impairment: a multicentre, phase 2b, non-randomised, open label study. Lancet Gastroenteraol Hepatol 2020: June 9; 1-9.

Kirschbrown WP, Wynne C, Kågedal M, Wada R, Li H, Wang B, Nijem I, Badovinac Crnjevic T, Gasser H, Heeson S, Eng-Wong J, Garg Amit. Development of a Subcutaneous Fixed‐Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose‐Finding Study. Journal of Clin Pharm. 2019 May: 59(5):702-716.

Wright RS, Collins MG, Stoekenbroek RM, Robson R, Wijngaard PLJ, Landmesser U, Leiter LA, Kastelein JJP, Ray KK, Kallend D. Effects of Renal Impairment on the Pharmacokinetics, Efficacy, and Safety of Inclisiran: An Analysis of the ORION-7 and ORION-1 Studies. Mayo Clin Proc. 2020 Jan;95(1):77-89.

Wynne C, Schwabe C, Vincent E, Schueler A, Ryding J, Ullmann M, Ghori V,Kanceva R, Stahl M. Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: A randomized, double-blind trial.Pharmacol Res Perspect. 2020 Apr;8(2):e00578.

Wynne C, Schwabe C, Sachdeva Batra S, Lopez-Lazaro L, Kankanwadi S. A comparative pharmacokinetic study of DRL_BZ, a candidate biosimilar of bevacizumab, with Avastin® (EU and US) in healthy male subjects. British Journal of Clinical Pharmacology. 2018 Oct:84(10):2352-2364.

Our Expertise

Our skilled, experienced team of research professionals will work with you to ensure timely delivery of projects with participant safety and quality of data at the forefront.

Quality is at the forefront of all our operations

Recruitment is key to project success

Our experienced research team ensures enviable trial retention and visit completion rates with our large biosimilar studies having retention and visit completion rates of 98%+

NZCR conducts clinical trials over a wide range of therapeutic areas

Examples of our specific areas of expertise are:

Examples

NZCR Key research indications and Specialist Collaborations

NZCR has well established collaborations with local medical specialists

NZCR Research Highlights and Publications

Examples of NZCR research publications are below:

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