iNGENū CRO in Canada

About iNGENū CRO

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnecessary barriers.

We are a physician-led, full-service CRO with in-house access to an established network of clinical trial research professionals including medical writing, quality assurance, scientific affairs, biostatistics, data management, pharmacokinetics, project management, monitoring, safety, and pharmacovigilance.

OUR FDA-EXCLUSIVE FOCUS:

As a full service CRO, our team members have the experience of hundreds of clinical trials behind them. Our unique, FDA-exclusive focus has created a CRO performing:

1. Clinical Trials (Phase 1, 2 and 3)
2. IND-Enabling Non-Clinical Studies with Data in FDA-Compliant SEND Format
3. FDA Regulatory Submissions (PIND, IND, NDA)

WHY WORK WITH US:

1. Government Grant Access: As an Australian CRO, all our clients (clinical and non-clinical) will receive up to 43.5% Government R&D Incentive to perform their research with us.

2. Fast, High-Quality Research: We excel in conducting fast-paced research that strictly adheres to FDA guidelines and regulations. Our clients' timelines are met without sacrificing quality.

3. FDA Regulatory Expertise: With extensive experience in FDA regulatory work, we specialize in making full FDA pre-IND and IND submissions for our clients.

4. Diverse Therapeutic Specialty Leaders: Our team comprises physician and scientific specialists with expertise in a wide variety of therapeutic areas, enabling us to provide highly tailored solutions that meet your unique clinical trial needs.