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Our areas of expertise are:

First-in-Human, Phase I – IV studies in healthy participant and patient populations.

 

Clinical trials include: 

    • Single and multiple ascending dose trials using small and large molecules plus food effect groups 
    • Umbrella and complex protocols  
    • Biosimilar trials  
    • Vaccine trials
    • Proof of concept and validation trials
    • Drug -Drug interactions 
    • Gene-modifying and Gene-editing technologies 
    • mRNA drugs 

Medical device trials include: 

    • Observational studies, including long-term follow up  
    • Protocol consultation and review
    • Feasibility and research project management support

We produce research in a wide range of therapeutic areas:

    • Renal Impairment
    • Hepatic Impairment
    • Oncology
    • Endocrinology
    • Respiratory
    • Metabolic  
    • Special Populations – Ethnic bridging
    • Inflammation
    • Gene editing or modifying
    • Analgesics
    • Cardiovascular

We provide Laboratory and Pharmacy manual consultation. 

We have established collaborations in all therapeutic areas (Read more link to our collaborators). 

 NZCR has onsite laboratory and pharmacy services and partnerships with local advanced laboratory and imaging service providers. 

Quality is at the forefront of all our operations

    • Precision and accuracy are paramount within the highly regulated world of clinical trials. Our focus on clear articulation and understanding helps researchers articulate their objectives, protocols, and methodologies, minimising misunderstandings and errors.  
    • Streamlined processes enable timely and accurate information accelerating decision-making processes. 
    • Our electronic quality management system is used to support operating processes and assist regulatory compliance. 
    • NZCR’s trials are approved by New Zealand’s regulatory authorities, the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) and the Health and Disability Ethics Committee (HDEC), to ensure all procedures comply with national and international guidelines for clinical research. 
    • FDA audited in 2017, 2021 and 2023 with numerous CRO and Sponsor audits completed. Any findings are actioned with robust responses provided.   

Recruitment is key to project success

  • Dedicated recruitment and marketing teams are focused on your trial. 
  • Active healthy participant and patient population databases ensure fast recruitment and trial startup. 
  • Our dedicated recruitment teams produce exceptional recruitment rates over a wide range of healthy and patient populations and therapeutic areas. 
Our experienced research team achieves enviable trial retention and visit completion rates with our large biosimilar studies having retention and visit completion rates of 98%+ 

Participant Retention

Recruitment Rate:

94% of all healthy volunteer participants were dosed on time in 2024.

Retention Rate:

98% of participants remained on the study for the entire study in 2024.

Net Promoter Score: 

NPS = 65% for the past 12 months. This is a measure of participant’s loyalty by looking at their likelihood of recommending NZCR to family and friends. A figure above 50% is considered excellent.  

NZCR conducts clinical trials over a wide range of therapeutic areas

Specific areas of expertise include:
  • Over 220+ Hepatology trials completed 
  • World-leading Primary Investigator Hepatologist – Professor Edward Gane 
  • Leading contributor to Hepatitis C cure and global efforts towards a Hepatitis B cure 
  • Over 55+ nephrology trials completed 
  • Experienced Primary Investigator Nephrologists – Dr Nick Cross and Professor Richard Robson 
  • Renal trials undertaken in both healthy and patient populations  
  • Over 55+ oncology trials completed 
  • Experienced Primary Investigator Oncologist – Dr Chris Wynne and Dr Tony Rahman 
  • Strong collaboration with local oncology specialty groups across New Zealand 
  • Over 15 gene modifying trials 
  • World-leading expertise, and world-first regulatory submissions  
  • Experienced physicians for regulatory guidance and medical oversight  
  • Over 42 biosimilar trials completed with 4000+ participants dosed 
  • Proven recruitment track record 
  • Consistent high retention and compliance rates of 98%+ 

Examples:

NZCR 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 2023 we completed a large biosimilar trial with a cross-over design, 160 healthy volunteers were dosed. The sponsors were delighted with our 100% retention and visit completion rates asking us to dose more than the originally requested volume by 14%. 

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% with 99.2% of trial visits attended as scheduled. 

40 healthy volunteers were recruited and dosed with a very tight inclusion and exclusion criteria, to support a poorly recruiting site overseas. 

NZCR Key research indications and Specialist Collaborations

NZCR Research Highlights:

Our focus on quality and innovation has resulted in many exciting medical breakthroughs. This has included the development of therapies for many previously untreatable diseases, including hepatitis, cystic fibrosis, paroxysmal nocturnal haemoglobinuria, alpha-1-antitrypsin deficiency, and neuromuscular diseases.

Examples of our research highlights are:  

    • 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 in world in vivo Gene editing trials (SiRNA, mRNA delivery, CRISPR/CAS9) 

Examples of NZCR publications:

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.