Nonclinical Program Development & Study Oversight
Designing and overseeing studies that meet global regulatory standards.
We provide end-to-end oversight of nonclinical studies spanning toxicology, pharmacology, ADME, DART, Juvenile, and Safety Pharmacology to ensure high-quality design, precise execution, GLP compliance, and regulatory-ready data.
What we provide:
- Study design aligned with clinical dosing rationale
- CRO selection, qualification & site assessments
- Study monitoring (US, EU, China, India)
- Exposure margin assessment & NOAEL justification
- Data QC and scientific interpretation
- Support for specialized routes (ocular, dermal, inhalation, CNS)
Nikao’s Unique Value:
- Hands-on oversight not passive reviewing
- Trusted global CRO partnerships
- Expertise in complex study types and sensitive populations