Keep up with the development of regulations and encompass the entire life cycle of drugs, and develop a robust pharmacovigilance system.
Meet regulatory requirements, lower the risk of drug re-registration. Extend product life cycles, explore new indications, create commercial value.Effectively manage the drug safety, guaranteeing patients to use medicines safely.


- Drafting of relevant reports of PV required for clinical research application
- Collection and medical reviews of SAE and SUSAR in clinical trials
- Submission of clinical trial SUSAR and new drug registration: Submit to drug regulatory authorities in E2B R2/R3 format
- Drafting and submission of DSUR
- 7/24 adverse events calling services
- Literature retrieval
- Entry and submission of individual case report
- Batch processing and submission of drug safety data from drug regulatory authorities
- Drafting and submission of PSUR and annual reports
- Overall outsourcing of important drug safety monitoring projects
- Other customized PV services
Pharmacovigilance crash course, a hands-on, project-based introduction to achieve personal growth and meet business needs.

PV fundamentals
Industry trends of pharmacovigilance
Construction of pharmacovigilance system
Pharmacovigilance staff training

PV advances
Pharmacovigilance risk managemen
MedDRA

Applications
Practice of SUSAR brief report
Pharmacovigilance practice
Guidance of applicable pharmacovigilance system
Submission requirements of FDA

International developments
ICH E2 guidelines




Regulations
in-depth interpretation of policies and regulations to ensure the progress of projects
Costs
use the essential drug monitoring information platform to replace part of the manpower and reduce project costs
Willingness
use mobile data entry mode to reduce the actual burden on project participants and improve the cooperation

Project Execution Phase: professional pharmacovigilance team assists with solutions formulation
•Communication with regulatory authorities to ensure compliance with regulatory requirements

Project execution phase: use electronic information processing platform to replace manpower for efficiency and lower costs
• PV medical writing in standardized norms with efficient communication and implementation
• Data entry at one time to satisfy the information collection from curative effect database and security-database
• The system forwards / generates the specified format, reporting security information efficiently and accurately