HAROM
- HUMAN ADVERSE REACTION ONLINE MONITORING SYSTEM
ABOUT
HAROM – Human Adverse Reaction Online Monitoring System (One of it’s kind) is the world’s most comprehensive real-time source of ICSRs management and to maintain a continually updated information of ICSRs in more than 150 countries. HAROM provides you a single source to carry out an easy processing and reporting of your ICSRs for legal Pharmacovigilance obligation globally.
HAROM has been designed to fasten the process of Case Processing in Pharmacovigilance which helps Pharmaceutical and Clinical Research Organizations to manage ICSRs data from multiple sources, meeting strict global compliance guidelines, and access with ease.
KEY FEATURES
CORE PHARMACOVIGILANCE
- HAROM enables end-to-end processing of ICSRs from all sources including automated system, easy reporting and transmission of cases, E2B compliance, and detailed analytics etc.
- Manage ICSR data from multiple sources like spontaneous, clinical trials, literature, PMS studies, regulatory etc.
- Compatible as per global regulatory guidelines
- Instinctive graphical edge
- Complete and integrated view of reported ICSRs
- Complete Training and IT support
- Technical team with appropriate qualifications, level of access and defined responsibilities to carry out operational activities
- Developed with an appropriate quality management system
- Validated system
- Defined procedure and well documented for any Change and Configuration Management
- Periodic evaluations for validity and compliance
- Electronic Signature
- In build quality tracking system
- Workflow management
DATA SECURITY
- Restricted access with user based configurations
- Appropriate built-in checks for the correct and secure processing of data
- Secured data by both physical and electronic means against damage
- Regular back-ups of all relevant data
COMPLIANCE
- 21 CFR Part 11 compliance
- International Conference on Harmonization’s guidelines for transmitting data elements in individual case safety reports (ICH:E2B)
FUNCTIONALITIES
- Personalized control panel
- User friendly system to ease the processing and reporting with unique functionalities
- Authorization based case processing activities
- Customized as per the client requirements
- Integrated and Automated workflows route cases through the data entry and assessment process
- Integrated MedDRA browser
- Inergrated workflow management
- Integrated Quality system
E-REPORTING
- On demand and quick reporting
- Electronic submission of ICSRs with pdf and XML reports
- Compatible with all Pharmacovigilance databases
- Automated and Customized report scheduling and Delievery
- Quality assurance through logical quality control checks
- Regulatory compliant audit trail
- PSUR reporting
KEY BENEFITS
1
HAROM has been designed by experts from Pharmacovigilance industry to simplify the process of ICSR data.
2
TIME SAVING: The time saved in using HAROM Literature Management System is excess of 65%
3
Allow time for improvements in Quality and data analysis
4
Improved compliance with cumulative data reviews and analysis.
5
Manual processing replaced by automated system with guaranteed delivery methods
6
Lowered cost as many manual review and data entry tasks are automated now.
7
Faster processing of cases with full track of misplaced cases which improved the regulatory compliance.
8
Increased case volumes with fewer resources results in increase productivity and the business.
9
Assured quality as automated data entry reduced data entry mistakes.
10
Aiding better decision making
