It is expected that each ICSR before reporting is supposed to be validated in lieu of minimal requirements. As a valid ICSR needs to have four minimum elements an adverse event, a reporter, a patient and a drug. The quality of data entry affects the further processing of the case. Details of the four pillars of a valid case have to be reported meticulously. Patient information has to follow the HIPPA code for confidentiality. Event report has to be detailed enough for the evaluator to decide on the cause of the adverse event. This would include chronological description of the event or events, nature, localization, severity, characteristics of the event, results of investigations and tests, start date, course and outcome, concomitant medications and other risk factors. The only way to manage this load is using latest software tools where ARS PV completely is qualified to monitor those recordings, inputs and is your partner in capturing data and generating of E2B XMLs for ICSRs which is supposed to be submitted to regulatoy authority.
- Advance reporting System is software solution that offers complex data analysis and querying of safety data sets, meeting all the global regulatory requirements, while ensuring high quality standards and compliances.
- Innovative dashboard tool for measuring ICSR compliance and it’s expeditedness.
- User friendly interface for new case creation and data entry.
- Case alert management for all workflow cases.
- Integrated outlook mailing facility for appropriate timely actions
- Enables you to make duplicate checks at the time of data entry stage very initially, reduces extra efforts for conducting duplicate check.
- Field labels can be understood by laymen.