Adverse Drug Reactions Monitoring System

An Indigenous Adverse Drug Reactions Monitoring System (ADRMS) by Indian Pharmacopoeia Commission (IPC), Ministry of Health & Family Welfare, Govt. of India, to ease reporting and monitoring of adverse events (side effects) on patients due to medical products (medicine, vaccine & medical device) for the safety of patients.

Key Modules:

• User management
• Reporter management
• Organization management
• Individual case safety report (ICSR) processing for drug, vaccine and medical device.
  • Report information
  • Primary reporter information
  • Patient & parent
  • Patient history & profiling
  • Adverse reaction integrated with Medical Dictionary for Regulatory Activities (MedDRA) 24.0
  • Drug profiling integrated with WHO Drug Dictionary
  • Adverse reaction assessment
• Direct reporting for individual customer/ health care professional
• Quality Control of ICSR
• Signal generation process based on Data
• Data Analytics
• Data exchange module for E2B(R2) & E2B(R3) standards
• Support Management
• Feedback System
• Communication Management
• MedDRA Browser
• WHO DD Browser

Salient Features

• ICRS Reporting process as per the E2B(R3) standards
• Support global data standards {E2B(R2) & E2B(R3)} for exchange of information.
• Support Adverse Reaction assessment
• Integrated with Mobile SMS and Email services
• ADRMS application fully integrated with third party available Medical Dictionary for Regulatory Activities (MedDRA).
• ADRMS architecture support global WHO drug dictionary and it can be integrated easily with SNOMED CT (Systematized Nomenclature of Medicine -- Clinical Terms).
• Support other international language can be integrated for reaction coding
• Protect the confidentiality of patient data
• Global assessment process for reaction
• Generate report in various formats (pdf, excel, XML, etc)
• Customer/ healthcare professional feedback reporting

Support Customization as per the need