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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 

Technical Specifications

Technologies like JAVA8, Spring Framework, Spring Security, Hibernate, Bootstrap 4 and PostgreSQL



Chief Investigator Details

Paras Nath Barwal