Regulatory Affairs for Clinical Trials
- Preparation and submission of clinical trial applications to regulatory authorities (RA) and perform follow up as per RA requirement.
- To support investigators with the preparation and submission of Institutional Review Board or Ethics Committee documentation
- Submission of DSUR, SAEs and other reports as per RA requirements
- Submission of clinical study reports
- Study transparency/disclosure
PharmXL further provide supports on import and supply and management of clinical trial investigational products.
- Study drug import and management
- Permission for Import/export of investigational product and biological samples
- Management of Investigational product:
- Local label design
- Storage & Distribution
- Return & destruction
- Facilitation and management of service vendors