iNGENu CRO
Company Details
Status: Private
Employees: 11-50
Location:
22/456 St Kilda Rd Melbourne 3004 VIC Australia
Type:
sample
sample
Technology:
About: ▶ WHAT WE DO:
iNGENū CRO delivers FDA-compliant clinical trials for US Biotechs and saves them 70% of their clinical trial costs... WITHOUT the lengthy timelines typically associated with clinical trials.
We manage all the heavy lifting to ensure that our clients can focus on what they do best – creating life-saving treatments.
▶ 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 I, II, and III)
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. We ensure that 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 the unique demands of your clinical trials.
▶ OUR TYPICAL CLIENT:
An early-stage US biotech company who is looking for:
• >70% cost reduction on FDA-compliant clinical and nonclinical trials
• All data being 21 CFR 312.120 compliant for US FDA submission
• Clinical trial startup time in 8-10 weeks
• Commence FIH clinical trials prior to opening an IND
• Perform rodent and second-species nonclinical studies at a fraction of the cost of the US
▶ READY TO TALK?
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iNGENu CRO | Active clinical trials on ClinicalTrials.gov
Active Clinical Trials Count | 0
No Active Trials Found On ClinicalTrials.gov.