Contract Research Organization (CRO) Australia – iNGENū CRO
Your Global Partner for Biotech Clinical Trials: Australian Excellence with iNGENū
iNGENū CRO is your partner for excellence in clinical research, dedicated to bringing innovative medicines to market faster and more efficiently. With a wealth of experience and a team of highly skilled professionals, we offer a comprehensive range of services to support your clinical trials from early phase to late phase studies.
- Early Phase Clinical Trials: We specialize in conducting Phase I clinical trials in Australia, providing customized solutions to meet your specific needs.
- Oncology: We have extensive experience in oncology trials, ensuring the highest standards of safety and efficacy.
- Late Phase Clinical Studies: We offer support for Phase III and IV clinical trials in Australia and New Zealand, leveraging our established clinical trial site networks.
- Regulatory and Site Set-up: We guide you through the complex regulatory processes and ensure seamless site activation.
- Clinical Trial Monitoring Services: Our experienced monitors meticulously track study progress, ensuring compliance with protocols and regulatory standards.
- Data Management: We capture, clean, and manage your clinical trial data, providing accurate and reliable results.
- Statistics: Our expert statisticians analyze your data, generating meaningful insights for decision-making.
- Medical and Scientific Writing: We produce clear and concise clinical study reports, manuscripts, and abstracts.
- Medical Monitoring and Pharmacovigilance: We safeguard patient safety by monitoring adverse events and ensuring compliance with regulatory requirements.
- Quality Control Processes and GCP Auditing: We maintain the highest quality standards throughout your clinical trial, ensuring data integrity and regulatory compliance.
Why Choose iNGENū CRO?
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Local Trials, Global Approvals
Australian expertise combined with direct FDA submission capabilities, offering a streamlined path for global approval.
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Disciplined, Cost-Efficient Execution
Every dollar is strategically allocated, eliminating unnecessary costs while maintaining the highest quality.
Australian-HQ'ed, Asia-Pacific Reach
Access high-quality trials in the Asia-Pacific region, enhancing speed and scalability.
Expertise from the Start
Engage directly with our team of highly qualified doctors and PhD scientists from the outset.
Reducing Clinical Trial Costs
- NGENū CRO specialises in helping biotechs conduct cost-effective clinical trials without compromising quality. Our expertise in regulatory strategies, trial design, and site selection allows us to maximize efficiency and minimize unnecessary expenses
Key Factors Behind Significant Cost Reduction
R&D Tax Incentive (RDTI) for Australian Biotechs
- Eligible biotech companies can access up to a 43.5% Australian Government Research and Development Incentive – a cash refund paid directly into the Sponsor’s bank account.
- This powerful incentive significantly reduces the financial burden of clinical trials, allowing biotechs to reinvest in further development and innovation.
Strategic Use of Asia-Pacific Sites
- Where appropriate, leveraging sites in the Asia-Pacific region can further optimize costs by reducing the cost per patient while maintaining high data quality.
- Our extensive network across the region allows us to select the most suitable locations for your trial while ensuring smooth regulatory integration with Australian and global submissions.
Decentralised Clinical Trials (DCTs) for Cost Efficiency
- Our expertise in Decentralized Clinical Trials (DCTs) enables Australian biotechs to reduce operational costs while enhancing patient recruitment and retention.
- DCT models reduce reliance on traditional site-based visits, lowering overall costs and increasing trial accessibility.
"We have been using iNGENū for a Phase 1, first-in-human trial of our investigational drug. We have used iNGENū for: Medical writing, project management, clinical data management and full end-to-end, clinical trial execution and monitoring.
We have been very happy with all aspects of the management of the clinical trial and have been particularly impressed by the out-of-the-box creative solutions to speed up and reduce overheads for our company during this clinical trial."
Giles Moss
Chief Executive Officer
Australia Headquarters
