Clinical Research Services
Pharmacovigilance
The Pharmacovigilance Department provides full-cycle, compliance-driven drug safety services, covering risk monitoring, signal detection, adverse reaction management, and the development of risk management plans. With a scientific and rigorous approach to building safety systems, we help enterprises meet domestic and international regulatory requirements and safeguard the safety of drugs throughout their entire lifecycle.
Pharmacovigilance
INTRODUCTION
The Pharmacovigilance Department is dedicated to providing comprehensive, compliance-oriented pharmacovigilance services for pharmaceutical enterprises, covering drug safety monitoring, risk assessment, adverse reaction management, signal detection, and risk management plan development. With a scientific and rigorous approach, we establish robust drug safety systems to help enterprises meet domestic and international regulatory requirements, enhance drug safety management capabilities throughout the product lifecycle, safeguard public health, and build a solid defense for drug safety.
OUR ADVANTAGES
Full Lifecycle Coverage
We have full-lifecycle pharmacovigilance service experience, having supported over 300 projects covering all phases—from IND, BE, Phase I to Phase III clinical studies, as well as NDA submission and post-marketing safety monitoring—to safeguard drug safety.
Multi-Category Layout
Our services cover both innovative drugs and generics, spanning chemical drugs, traditional Chinese medicines, and biological products. We have pharmacovigilance experience in projects involving advanced therapies such as immunotherapy, targeted radiotherapy, and cell therapy, meeting diverse R&D needs.
Broad Disease Coverage
We serve a wide range of therapeutic areas, including oncology, liver diseases, endocrine disorders, nephropathy, hematological diseases, ophthalmic diseases, and dermatological conditions. We also have rich project experience in rare disease fields, helping ensure medication safety for special populations.
SERVICE CONTENT
Document Review and Training
- We provide protocol review, investigator's brochure audit, MedDRA and WHO-Drug standard coding, literature screening, project deployment, and team training services to ensure pharmacovigilance work starts in compliance.
System Integration and Configuration
- We support pharmacovigilance system configuration and integration testing, meeting data submission standards in regions like China, the US, and the EU, to ensure efficient global transmission of drug safety information.
Full Process of Individual Case Reporting
- We cover end-to-end lifecycle management of individual case safety reports (ICSRs), including data entry, review, medical assessment, external review, expedited report drafting, cross-checking, and consistency verification, to ensure data accuracy and compliance.
Risk Document Preparation
- We provide professional drafting services for Risk Management Plans (RMP), risk control plans, and periodic safety update reports (PSUR/DSUR/PBRER), helping enterprises fully manage drug risks.