Development
Proof of Concept (POC) &Pivotal Clinical Research
Statistical Expertise: Designs of proof-of-concept trials and pivotal trials are diverse and choosing which design to use is largely depending on statistical science. We have completed more than 5 FDA-delivered NDA filings. We provide expert consulting services through trial design, implementation, and reporting phases.
Drug safety and surveillance:Our independent PV team and experienced medical monitors handle incidents regarding drug adverse events in particular concerns to regulators.
Our clinical operations team is located across major cities in China and covers major clinical trial facilities; We provide clinical audit and project management services that meet ICH national regulatory requirements.
Our own biological sample analysis lab conducts population PK determination and analysis.
We have extensive experience in setting up and managing Independent Data Monitoring Committees (DMCs).
Provide unblinding services that meet regulatory requirements for double-blind trials.
