Adverse Drug Reactions Monitoring System
An Indigenous Adverse Drug Reactions Monitoring System (ADRMS) by Indian Pharmacopoeia Commission.
Brief Description
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
Group Coordinator
E-Governance Division