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 – small and large molecule, Phase 1 – IV, Biosimilar, Food effect, Proof of concept, Drug interactions, Umbrella and complex protocols, in healthy participants and patient populations.
  • 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:

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 Mark Marshall

Dr Nick Cross

Dr Michael Collins

 

Hepatology Professor Ed Gane Dr Ashok Raj

Dr Tim King

Dr Helen Evans (Paediatrics)

Dr Jeffrey Ngu

Oncology Dr Chris Wynne

Dr Rajiv Kumar

Dr Catherine Han
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.

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