Amanda Devito

Background

About Amanda Devito

WHAT WE DO: iNGENū CRO partners with innovative biotechs to deliver seamless, high-quality clinical trials with a dual focus on local expertise and direct FDA submission capability. We manage all the heavy lifting to ensure that our clients can focus on what they do best – creating life-saving treatments. OUR EXPERTISE: 1. Clinical Trials tailored to meet diverse sponsor needs. FDA Regulatory Submissions, ensuring data generated locally aligns with global standards. Comprehensive trial oversight across Australia and the Asia-Pacific region, backed by Australian-based project management. WHY WORK WITH US: 1. Local Trials, Global Approvals: We uniquely combine Australian expertise with direct FDA submission capabilities, offering a streamlined path for sponsors to achieve global approval. Disciplined, Cost-Efficient Execution: iNGENū CRO takes a highly strategic and disciplined approach to clinical research, ensuring that every dollar is directed toward generating meaningful outcomes. Asia-Pacific Reach: Expand your trial footprint with cost-efficient, high-quality research in the Asia-Pacific region, supported by Australian-based oversight to ensure quality and reliability. Expertise from the Start: At iNGENū CRO, you engage directly with experienced specialists from the outset. Our team is comprised of highly qualified doctors and PhD scientists, providing immediate, precise answers to your complex inquiries. OUR TYPICAL CLIENT: A biotech company who is looking for: • Expert guidance on conducting clinical trials in Australia and the Asia-Pacific region. • A streamlined path to global regulatory approvals, including the U.S. FDA. • Cost-effective trial expansion while maintaining high standards of quality and compliance. READY TO TALK? Like to find out more? Book a time to connect with us.