Pharmacovigilance Technology
IDDCR provide a range of pharmacovigilance technology services to support the pharmaceutical industries. These technologies help streamline safety data management, reporting, and analysis, ensuring efficient and accurate pharmacovigilance practices.
Safety Data Management Systems (SDMS)
Selection and Implementation: Assisting in the selection, implementation, and validation of SDMS.
Data Migration: Migrating existing safety data into the SDMS.
Data Standardization: Ensuring data consistency and standardization across multiple sources.
Safety Reporting Systems
Regulatory Reporting: Automating the generation of regulatory reports, such as periodic safety update reports (PSURs) and individual case safety reports (ICSRs).
Adverse Event Reporting: Facilitating the capture, review, and reporting of adverse events.
Query Management: Streamlining the query management process to ensure timely resolution of queries.
​Signal Detection Systems
Data Mining: Using advanced data mining techniques to identify potential safety signals.
Risk Assessment: Quantifying the risk associated with identified safety signals.
Prioritization: Prioritizing safety signals based on their severity and likelihood.
Safety Data Analysis Tools
Statistical Analysis: Providing tools for statistical analysis of safety data, including descriptive statistics, hypothesis testing, and survival analysis.
Data Visualization: Creating visualizations to help identify trends and patterns in safety data.
Integration with Other Systems
EDC Integration: Integrating pharmacovigilance systems with Electronic Data Capture (EDC) systems to facilitate data sharing and analysis.
Clinical Trial Management Systems (CTMS): Integrating with CTMS to track safety events and manage safety-related activities.
Laboratory Information Management Systems (LIMS): Integrating with LIMS to capture and analyze safety data from laboratory tests.