As an Australian-based CRO specializing in the FDA regulatory pathway, iNGENū is able to cut 70 percent of the cost of a full GCP, FDA-compliant clinical trial. And we can reduce startup time by over 80%.
Yes. That’s a significant cut.
Understandably, many people who are new to iNGENū wonder how we do it. So, in this article, we'll talk you through some of the most common questions we’re asked.
Is Australian data valid for the FDA?
The answer is…
Absolutely.
- Since 2018, more than half of all NDAs submitted to the FDA have had Australian data as a component.
- The FDA has approved and is continuing to approve Australian data without issue.
- Plus, iNGENū has proven expertise in meeting FDA standards. All data collected is 21 CFR 312 120 compliant in accordance with FDA guidelines.
iNGENū is a full-service Contract Research Organization, and one of the only in Australia with integrated services, encompassing both nonclinical and clinical expertise.
This spans from preclinical drug development through to Phase 1 and Phase 2 clinical trials.
We have significant FDA regulatory experience, with our Regulatory Affairs professionals collectively having handled more than 100 pre-IND submissions and numerous INDs throughout their careers.
Can Australian clinical sites even secure enough patients?
Yes.
Australia might have a relatively low population of 25 million people, but the population is highly concentrated in four major cities, which makes access relatively easy.
Plus, with fewer competing studies and more centralized, searchable data, it is often easier to find patients with rare diseases or orphan syndromes.
How can we ensure CRO oversight when trials are happening on the other side of the world?
As a new client, this one is sure to cross your mind.
At iNGENū, we’ve specifically built our business to serve American clients. So transparency, visibility, and service culture are all fundamental parts of our DNA.
iNGENū’s Relationship Managers are based in the US.
Additionally, we hold weekly strategy meetings with all our clients to ensure effective communication and accurate feedback are maintained.
Do you have other questions for us?
Book a discovery call to get the answers.
Our application process is simple
- First, book a Discovery Call with one of our Therapeutic Experts by completing the form below
- After the Discovery Call, we’ll put forward a proposal and strategy within 5 business days
- If you’d like to proceed from there, we only require a signed letter of intent and a small refundable deposit to start designing your clinical trial