“Optimal Clinical Trials has done an excellent job for us on this trial and I hope to work with them again. I would recommend them to any other CRO and sponsor who want world class recruitment and quality data in a timely fashion.”

-Carly Anthony, Lead CRA

“Optimal Clinical Trial provided us with world-class recruitment- 123% recruitment target in 1/3 of the time allocated to the study”

-CRO

“With the study deadline approaching Dr Montgomery’s team worked incredibly hard and randomized most of the remaining patients which meant we were able to reach our target number with 1 day to spare and avoided a costly and time consuming extension of the study saving us and the sponsor a considerable amount of money and resources.”

-CRO

“Optimal Clinical Trials exceeded recruitment targets, and provided high quality data in a very timely fashion. Optimal Clinical Trials were excellent to work with and we would definitely recommend them and look forward to working with them again in the future.”

-Large International Sponsor

 

Pharmaceutical Sponsors and CROs

Optimal Clinical Trials is an independent, clinical research company in Auckland, New Zealand. We specialize in phase II-IV trials.

Optimal Clinical Trials is the solution for pharmaceutical companies and CROs who want to perform clinical studies in New Zealand.

Our research team includes doctors and nurses who are all GCP trained, have experience in Clinical Trials from Phase I-IV and enjoy what we do.

Our knowledge, experience and enthusiasm ensure a well-organized and high quality research site that will provide clean, quality data with rapid enrollment.

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Free Report: The definitive CRO & sponsors guide to Successful (high recruitment and quality data) Clinical Trials in New Zealand.” – How to avoid the 5 biggest mistakes”




 

We are interested in:

  • Considering all phase II-IV trials that can be done as outpatients. We have access to a large database of patients through General Practice (Family Practice) clinics with a wide variety of conditions.
  • Acute trials
  • Healthy volunteer trials

We focus on providing you with:

  • Quality data in a timely fashion
  • World class recruitment
  • Excellent consent processes and documentation
  • High standards of internal quality control and effective processes
  • Strict adherence to GCP
  • Recruiting and training high quality staff
  • Hands on PI’s
 

Quality Data

Our clinical focus is on producing high quality research.  We emphasize attention to patient safety and delivery of quality clinical data.

We have developed an internal quality control process, which ensures the quality of our work.

We are looking for continuous improvement and welcome all feedback.
Our client partnership goal is to high quality data, timely study start-up and world class recruitment while ensuring patient safety and integrity of data.

Recruitment

  • We recruit subjects from our network of General Practice (Family Practices) databases, radio, internet, print and other targeted advertisements.
  • Our trial-specific targeted marketing strategies reach large numbers of potentially eligible patients. Extensive pre-screening is done to ensure patients are fully eligible to participate in a particular trial.
  • Auckland has a population over 1.3 million. There is wide ethnic diversity and therefore a variety of medical conditions.
  • We also have affiliations with a number of specialists so can consider a wide range of trials.
 

Start-Up and Ethics Submissions

We aim to provide prompt turnaround on internal contracts, feasibility and ethics committee submissions to ensure your study is up and running on time.

Regulatory Requirements for Clinical Trials in New Zealand

Before Clinical Trials can be conducted in New Zealand they must have

  • HDEC (Health, Disability & Ethics Committee) and
  • Regulatory Approval – (Medsafe) – coordinated through SCOTT (Standing Committee On Therapeutic Trials). Not all trials require regulatory approval.

These two processes occur in parallel. The time can vary but usually takes approximately four to six weeks from submission to approval depending on how complex the study is.

Health & Disability Ethics Committee
All applications to HDECs must be submitted through the Online Forms website and are allocated to the next available meeting. The committees meet every week and studies are usually approved within 4-6 weeks. NZ utilizes a central ethics review system – 1 application for all NZ study sites.

The committees require the following information:

  • Completed ethics application form
  • Study protocol
  • Investigator CV
  • Investigational drug brochure & and any subsequent safety updates.
  • Patient information Sheet (PIS) and Consent Forms (CF)
  • Evidence of sponsor insurance and CI indemnity
  • Any advertisements

For meeting dates see http://ethics.health.govt.nz

SCOTT
The pharmaceutical company or local NZ representative, is responsible for the Regulatory application for the trial. The information that is required includes:

  • Completed SCOTT application form
  • Study protocol
  • Investigator(s) CV
  • Agreement to conduct the trial
  • Investigational drug brochure and any subsequent safety reports.
  • Patient information Sheet (PIS) and Consent Forms (CF)
  • Evidence of sponsor insurance and CI indemnity
  • Application fee ($6525.00 NZD)
  • GMP certificate and license of manufacturer and packaging site
  • Copy of proposed drug labels

Approvals are typically processed within 4 weeks. Applications are submitted via the online system.

Site Capabilities

 1.    Staff

  • All GCP trained.
  • Multiple primary investigators and sub investigators.
  • Experienced, enthusiastic study coordinators, study nurses and admin staff.
 

2.    Recruitment department

 

3.    Finance Department

 

4.    Quality Assurance Department

  • Source doc creation
 

5.    Training Department

  • SOPs
 

6.    Access to Record Storage Facility

 


7.    Regulatory Department

  • Rapid feasibility completion
  • Rapid CTA/budget turnaround
  • Fast-track study start-up
 

8.    In-house or nearby access to:

  • Secured Drug storage
  • 12 Lead EKG/ECG
  • Wireless/FAX/Copier/Scanner
  • In-House Certified Phlebotomist
  • Radiology modalities: X-RAY, Ultrasound, MRI, CT, DEXA
  • Treadmill for cardiac testing if required
  • Centrifuges
  • Regular calibration of equipment.