PCC nomination supporting studies

IND-enabling studies

NDA/BLA-enabling studies

Exploration of the MOA

PD Evaluation (in vitro/in vivo)

ADME studies of chemical drugs

PK studies of biologics

Clinical development strategy

Phase I/II studies

Study design and operations

Medical monitoring

Pharmacovigilance

Data management

Phase II/III studies

Study design and operations

Medical monitoring

Pharmacovigilance

Reporting and regulatory submission

Supporting clinical services