Amarex Clinical Research is a specialized clinical research organization (CRO) delivering comprehensive regulatory and clinical trial management services [1]. Under the leadership of President Kush Dhody, M.D., M.S., and a seasoned executive team, the organization maintains close collaboration with sponsors and regulatory authorities to navigate complex drug development landscapes [4].
- Kush Dhody, M.D., M.S. - President
- Hana Mekonnen, M.A. - Chief Operating Officer
- Herman Wong, B.S. - Senior Vice President, Information Technology
- Chia-Hua Maggie Ho, DPhil - Vice President & COO, Amarex Taiwan [4]
With over two decades of experience, Amarex has established particular expertise in three key therapeutic areas:
- 20+ years specialized experience with 45+ clinical trials across 315+ sites
- 4,035+ patients enrolled
- Five successful NDA market approvals [1]
- 15+ years dedicated experience managing 40+ clinical trials
- 2,000+ patients enrolled across 300+ sites
- Multiple regulatory approvals including INDs, NDAs, and PMAs [2]
- 20+ years experience with 15+ clinical trials across 500+ sites
- 20,000+ patients enrolled
- Five market approvals (2 NDAs, 1 PMA, 2 510(k)s) [3]
- Full-spectrum FDA submissions (IND, NDA, BLA, IDE, ANDA, PMA)
- Fast track and orphan drug designations
- Emergency use authorizations
- Electronic submissions through FDA's Gateway [3]
- New Chemical Entities (NCEs)
- Botanical products
- Biologics and vaccines
- Cell and gene therapies
- Medical devices and diagnostics
- Authorization for Progerinin clinical trial for ultra-rare Progeria [1]
- Orphan drug designation for Gibson Oncology's LMP744 [2]
- Successful FDA GCP audit completion [3]
The company's innovation-driven culture emphasizes professional development and staff retention, ensuring consistent project oversight and long-term trial success [4]. This approach has earned Amarex recognition among the top 20 bioscience employers by the Washington Business Journal [3], while maintaining an impressive operational track record of over 400 clinical trials and 25 regulatory approvals [5].