Pivotal trials for regulatory approval

Discuss your regulatory studies with Edge Trials early in your planning.

Discuss Your Trial

Regulatory studies need researchers able to meet the standards needed to withstand regulatory audit. Edge Trials have the experienced team and infrastructure to meet these standards.

Overview

We have worked with commercial partners to bring their products to market through regulatory studies - for Europe and the FDA. Regulatory studies require the highest standards in research quality, which we  pride ourselves on being able to deliver. We welcome you to discuss your needs and timelines. We work collaboratively across New Zealand, and therefore have a strong track record in rapid enrolment and study completion timelines.

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About Edge Trials

Edge Trials was founded specifically to conduct commercial clinical research in diabetes and endocrinology - both in the device and medication fields. As an independent unit, we are flexible, and efficient, without compromising scientific integrity. Importantly, we conduct research across the lifespan, with our team having over a decade of experience in both paediatric and adult clinical trials.

We are located within the health precinct in Christchurch, New Zealand. Our team is strategically located alongside pharmacy, laboratory, radiology,  inpatient and outpatient facilities. Our premises are modern and world class in order to meet the needs of commercial trials, including regulatory studies.

Meet The Team

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Clinical trial solutions tailored to your needs

Tailored Consulting

Led by global leaders in diabetes technology, with 40+ feasibility and pivotal trials delivered.

Tailored Consulting

Led by global leaders in diabetes technology, with 40+ feasibility and pivotal trials delivered.

Efficient Delivery

Proven ability to move from concept to first patient in ~12 weeks, without compromising quality.

Efficient Delivery

Proven ability to move from concept to first patient in ~12 weeks, without compromising quality.

Rigorous Standards

Scientific integrity backed by a strong publication record and robust internal quality procedures.

Rigorous Standards

Scientific integrity backed by a strong publication record and robust internal quality procedures.

Questions? Answers!

Find quick answers to the most common questions we're being asked.

How long does it take from research concept to first patient first visit?

This depends on how complete and/or complex the study protocol. Typically from first contact to first patient first visit, is approximately 12 weeks.

How does Edge Trials differ from other research providers?

We have a unique set of skills – from being able to write protocols, set up electronic research databases, to statistical analyses. We can provide for short feasibility studies, to large scale multi-centre pivotal studies. We can cover the lifespan – with both paediatric and adult experience. Further, New Zealand is uniquely positioned, where regulatory processes for conducting first in human studies are efficient, and we can therefore accelerate research programs.

Do timezone differences from NZ cause issues?

The team at Edge are highly flexible. Having worked with international sponsors for over a decade, we’ve never encountered time-zone issues.

Is Edge Trials a CRO?

Edge Trials is not a CRO, however, we conduct all study procedures commonly performed by CROs. Reach out and find out what we can offer for your needs.

Would you conduct studies outside the diabetes technology space?

Discuss your study with us. We don’t conduct phase I and II studies, but are co-located within a research precinct that does, and can likely connect your needs with others if we can’t provide the service for your study needs. Our health expertise is within diabetes and endocrinology.

Feel free to mail us for any enquiries

Questions? Answers!

Find quick answers to the most common questions we're being asked.

How long does it take from research concept to first patient first visit?

How does Edge Trials differ from other research providers?

We have a unique set of skills – from being able to write protocols, set up electronic research databases, to statistical analyses. We can provide for short feasibility studies, to large scale multi-centre pivotal studies. We can cover the lifespan – with both paediatric and adult experience. Further, New Zealand is uniquely positioned, where regulatory processes for conducting first in human studies are efficient, and we can therefore accelerate research programs.

Do timezone differences from NZ cause issues?

The team at Edge are highly flexible. Having worked with international sponsors for over a decade, we’ve never encountered time-zone issues.

Is Edge Trials a CRO?

Edge Trials is not a CRO, however, we conduct all study procedures commonly performed by CROs. Reach out and find out what we can offer for your needs.

Would you conduct studies outside the diabetes technology space?

Discuss your study with us. We don’t conduct phase I and II studies, but are co-located within a research precinct that does, and can likely connect your needs with others if we can’t provide the service for your study needs. Our health expertise is within diabetes and endocrinology.

Feel free to mail us for any enquiries

Questions? Answers!

Find quick answers to the most common questions we're being asked.

How long does it take from research concept to first patient first visit?

This depends on how complete and/or complex the study protocol. Typically from first contact to first patient first visit, is approximately 12 weeks.

How does Edge Trials differ from other research providers?

We have a unique set of skills – from being able to write protocols, set up electronic research databases, to statistical analyses. We can provide for short feasibility studies, to large scale multi-centre pivotal studies. We can cover the lifespan – with both paediatric and adult experience. Further, New Zealand is uniquely positioned, where regulatory processes for conducting first in human studies are efficient, and we can therefore accelerate research programs.

Do timezone differences from NZ cause issues?

The team at Edge are highly flexible. Having worked with international sponsors for over a decade, we’ve never encountered time-zone issues.

Is Edge Trials a CRO?

Edge Trials is not a CRO, however, we conduct all study procedures commonly performed by CROs. Reach out and find out what we can offer for your needs.

Would you conduct studies outside the diabetes technology space?

Discuss your study with us. We don’t conduct phase I and II studies, but are co-located within a research precinct that does, and can likely connect your needs with others if we can’t provide the service for your study needs. Our health expertise is within diabetes and endocrinology.

Feel free to mail us for any enquiries

Diabetes technology feasibility studies

Discuss your regulatory studies with Edge Trials early in your planning.

Discuss Your Trial

Regulatory studies need researchers able to meet the standards needed to withstand regulatory audit. Edge Trials have the experienced team and infrastructure to meet these standards.