Our pharmacovigilance (PV) team has experience in working on more than 100 regional and global projects. Our team has decades of experience in working at both large and small biopharma companies and CROs. With the desire to always put the customers’ needs first, the pharmacovigilance team merges their expertise, premier professionalism, and commitment to quality in order to guide customers through a successful and safe development journey, from discovery through submission in both drug and medical devices.
Clinical pharmacology services including:
- PV system setup
- Clinical safety data management
- Post marketing safety data management
- PV database system service
- Signal detection and evaluation
- Development Safety Updated Reports (DSUR)
- Risk Management Plan (RMP)
- Periodic Safety Updated Reports (PSUR)
- PV training and consultation
