Pharmacovigilance Services
Provide pharmacovigilance total solutions and set a benchmark for Chinese pharmacovigilance.

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.

Pharmacovigilance System
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eArchives-intro-chart
Pharmacovigilance Business Process Outsourcing —— Professional, Comprehensive and Close to Customers
Top-level Information Security Management System 150+ Team with PV Experts & IT Engineers
Before approval
Formulation of risk management plans
  • 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
After approval
PV processes formulation and system implementation
  • 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
Online Pharmacovigilance Training

Pharmacovigilance crash course, a hands-on, project-based introduction to achieve personal growth and meet business needs.

PV fundamentals

Basic concepts of pharmacovigilance
Industry trends of pharmacovigilance
Construction of pharmacovigilance system
Pharmacovigilance staff training

PV advances

Pharmacovigilance signal detection
Pharmacovigilance risk managemen
MedDRA

Applications

Compulsory course for SAE filling
Practice of SUSAR brief report
Pharmacovigilance practice
Guidance of applicable pharmacovigilance system
Submission requirements of FDA

International developments

GVP guidelines
ICH E2 guidelines
Mobile APP—eCollege Makes Learning More Convenient
Diverse Course Modes : MP3 audio&Text；Video
Courses with Big names: fusion of key points & cases
Curriculum test: review and improve learning results
Essential Drug Monitoring Projects

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

the Advantage of Project Execution

Project Execution Phase:
professional pharmacovigilance team assists with solutions formulation

• Solutions formulation: Develop specific monitoring plans based on product characteristics and existing
•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

• Electronic data management to ensure its completeness and accuracy
• 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